James H Doroshow

Summary

Affiliation: National Institutes of Health
Country: USA

Publications

  1. ncbi Phase II trial of PN401, 5-FU, and leucovorin in unresectable or metastatic adenocarcinoma of the stomach: a Southwest Oncology Group study
    James H Doroshow
    Division of Cancer Treatment and Diagnosis, National Cancer Institute, City of Hope National Medical Center, Duarte, CA, USA
    Invest New Drugs 24:537-42. 2006
  2. ncbi Antiproliferative mechanisms of action of the flavin dehydrogenase inhibitors diphenylene iodonium and di-2-thienyliodonium based on molecular profiling of the NCI-60 human tumor cell panel
    James H Doroshow
    Center for Cancer Research, National Cancer Institute, National Institutes of Health, 37 Convent Drive, Bethesda, MD 20892, USA
    Biochem Pharmacol 83:1195-207. 2012
  3. ncbi Advances in using PARP inhibitors to treat cancer
    Shivaani Kummar
    Division of Cancer Treatment and Diagnosis, Bldg, 31, Room 3A 44, 31 Center Drive, National Cancer Institute, Bethesda, MD, 20892, USA
    BMC Med 10:25. 2012
  4. ncbi Five strategies for accelerating the war on cancer in an era of budget deficits
    James H Doroshow
    National Cancer Institute, Bethesda, MD 20892, USA
    Oncologist 14:110-6. 2009
  5. ncbi Role of Phase 0 trials in drug development
    James H Doroshow
    Division of Cancer Treatment and Diagnosis, National Cancer Institute, NIH, Bethesda, MD 20892, USA
    Future Med Chem 1:1375-80. 2009
  6. ncbi Oncologic phase 0 trials incorporating clinical pharmacodynamics: from concept to patient
    James H Doroshow
    Division of Cancer Treatment and Diagnosis, and the Laboratory of Molecular Pharmacology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland 20892, USA
    Clin Cancer Res 14:3658-63. 2008
  7. ncbi Phase I trial of GTI-2040, oxaliplatin, and capecitabine in the treatment of advanced metastatic solid tumors: a California Cancer Consortium Study
    Stephen I Shibata
    Department of Medical Oncology, City of Hope Comprehensive Cancer Center, 1500 E Duarte Road, Duarte, CA 91010, USA
    Cancer Chemother Pharmacol 64:1149-55. 2009
  8. ncbi Phase 0 clinical trial of the poly (ADP-ribose) polymerase inhibitor ABT-888 in patients with advanced malignancies
    Shivaani Kummar
    Center for Cancer Research and the Division of Cancer Treatment and Diagnosis, National Cancer Institute, NIH, Bethesda, MD 20892, USA
    J Clin Oncol 27:2705-11. 2009
  9. ncbi Prognostic indicators and survival in patients with stage IIIB inflammatory breast carcinoma after dose-intense chemotherapy
    George Somlo
    Department of Medical Oncoilogy and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA 91010, USA
    J Clin Oncol 22:1839-48. 2004
  10. ncbi Phase I trial of fixed-dose rate gemcitabine in combination with bortezomib in advanced solid tumors
    Thehang Luu
    Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, 1500 E Duarte Rd, Duarte, CA 91010, USA
    Anticancer Res 30:167-74. 2010

Detail Information

Publications82

  1. ncbi Phase II trial of PN401, 5-FU, and leucovorin in unresectable or metastatic adenocarcinoma of the stomach: a Southwest Oncology Group study
    James H Doroshow
    Division of Cancer Treatment and Diagnosis, National Cancer Institute, City of Hope National Medical Center, Duarte, CA, USA
    Invest New Drugs 24:537-42. 2006
    ..2 months. The ability to safely deliver twice the usual dose of 5-FU with leucovorin on a weekly schedule suggests that oral uridine analog supplementation with PN401 may enhance the therapeutic index of the fluoropyrimidines...
  2. ncbi Antiproliferative mechanisms of action of the flavin dehydrogenase inhibitors diphenylene iodonium and di-2-thienyliodonium based on molecular profiling of the NCI-60 human tumor cell panel
    James H Doroshow
    Center for Cancer Research, National Cancer Institute, National Institutes of Health, 37 Convent Drive, Bethesda, MD 20892, USA
    Biochem Pharmacol 83:1195-207. 2012
    ..These findings suggest that DPI and DTI may act therapeutically by altering ROS-related signal transduction...
  3. ncbi Advances in using PARP inhibitors to treat cancer
    Shivaani Kummar
    Division of Cancer Treatment and Diagnosis, Bldg, 31, Room 3A 44, 31 Center Drive, National Cancer Institute, Bethesda, MD, 20892, USA
    BMC Med 10:25. 2012
    ....
  4. ncbi Five strategies for accelerating the war on cancer in an era of budget deficits
    James H Doroshow
    National Cancer Institute, Bethesda, MD 20892, USA
    Oncologist 14:110-6. 2009
    ....
  5. ncbi Role of Phase 0 trials in drug development
    James H Doroshow
    Division of Cancer Treatment and Diagnosis, National Cancer Institute, NIH, Bethesda, MD 20892, USA
    Future Med Chem 1:1375-80. 2009
    ....
  6. ncbi Oncologic phase 0 trials incorporating clinical pharmacodynamics: from concept to patient
    James H Doroshow
    Division of Cancer Treatment and Diagnosis, and the Laboratory of Molecular Pharmacology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland 20892, USA
    Clin Cancer Res 14:3658-63. 2008
    ....
  7. ncbi Phase I trial of GTI-2040, oxaliplatin, and capecitabine in the treatment of advanced metastatic solid tumors: a California Cancer Consortium Study
    Stephen I Shibata
    Department of Medical Oncology, City of Hope Comprehensive Cancer Center, 1500 E Duarte Road, Duarte, CA 91010, USA
    Cancer Chemother Pharmacol 64:1149-55. 2009
    ..It was combined with oxaliplatin and capecitabine in a phase I trial in patients with advance solid tumors based on previous studies demonstrating potentiation of chemotherapy with ribonucleotide reductase inhibitors...
  8. ncbi Phase 0 clinical trial of the poly (ADP-ribose) polymerase inhibitor ABT-888 in patients with advanced malignancies
    Shivaani Kummar
    Center for Cancer Research and the Division of Cancer Treatment and Diagnosis, National Cancer Institute, NIH, Bethesda, MD 20892, USA
    J Clin Oncol 27:2705-11. 2009
    ..It was a first-in-human study of the poly (ADP-ribose) polymerase (PARP) inhibitor ABT-888 in patients with advanced malignancies...
  9. ncbi Prognostic indicators and survival in patients with stage IIIB inflammatory breast carcinoma after dose-intense chemotherapy
    George Somlo
    Department of Medical Oncoilogy and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA 91010, USA
    J Clin Oncol 22:1839-48. 2004
    ..Tumor- and treatment-related factors were analyzed to generate a prognostic model...
  10. ncbi Phase I trial of fixed-dose rate gemcitabine in combination with bortezomib in advanced solid tumors
    Thehang Luu
    Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, 1500 E Duarte Rd, Duarte, CA 91010, USA
    Anticancer Res 30:167-74. 2010
    ..Bortezomib demonstrates synergism with gemcitabine via a fixed-dose rate (FDR). The aim of this phase I trial in solid tumors was to establish the maximum tolerated dose (MTD) and safety data for this combination...
  11. ncbi A phase I trial of UCN-01 and prednisone in patients with refractory solid tumors and lymphomas
    Shivaani Kummar
    Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA
    Cancer Chemother Pharmacol 65:383-9. 2010
    ..We designed a phase I study to determine the maximum tolerated dose (MTD) of UCN-01 with prednisone in patients with advanced malignancies...
  12. ncbi Phase I trial of intraperitoneal gemcitabine in the treatment of advanced malignancies primarily confined to the peritoneal cavity
    Robert J Morgan
    Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, California, USA
    Clin Cancer Res 13:1232-7. 2007
    ..To determine the maximally tolerated dose, toxicity, and pharmacokinetics of i.p. gemcitabine...
  13. ncbi Immunohistochemical detection of poly(ADP-ribose) polymerase inhibition by ABT-888 in patients with refractory solid tumors and lymphomas
    Sherry X Yang
    Division of Cancer Treatment and Diagnosis, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, MD, USA
    Cancer Biol Ther 8:2004-9. 2009
    ..We aimed to determine whether the PARP inhibitor ABT-888 hits its therapeutic target in tumors by immunohistochemistry during a Phase 0 trial conducted at the National Cancer Institute...
  14. ncbi Dose-escalating and pharmacologic study of oxaliplatin in adult cancer patients with impaired hepatic function: a National Cancer Institute Organ Dysfunction Working Group study
    Timothy W Synold
    City of Hope Comprehensive Cancer Center, Duarte, California, USA
    Clin Cancer Res 13:3660-6. 2007
    ..To determine the toxicities, pharmacokinetics, and maximally tolerated doses of oxaliplatin in patients with hepatic impairment and to develop formal guidelines for oxaliplatin dosing in this patient population...
  15. ncbi Up-regulation and sustained activation of Stat1 are essential for interferon-gamma (IFN-gamma)-induced dual oxidase 2 (Duox2) and dual oxidase A2 (DuoxA2) expression in human pancreatic cancer cell lines
    Yongzhong Wu
    Laboratory of Molecular Pharmacology of the Center for Cancer Research, Division of Cancer Treatment and Diagnosis, NCI, National Institutes of Health, Bethesda, MD 20892, USA
    J Biol Chem 286:12245-56. 2011
    ....
  16. ncbi Paclitaxel-based high-dose chemotherapy with autologous stem cell rescue for relapsed germ cell cancer
    Kim A Margolin
    Department of Medical Oncology, City of Hope National Medical Center, Duarte, California 91010, USA
    Biol Blood Marrow Transplant 11:903-11. 2005
    ..The Beyer prognostic system is a valuable predictor for patients undergoing aPSCT...
  17. ncbi Phase I study of PARP inhibitor ABT-888 in combination with topotecan in adults with refractory solid tumors and lymphomas
    Shivaani Kummar
    Center for Cancer Research and Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, USA
    Cancer Res 71:5626-34. 2011
    ..Results of this trial reveal that PARP inhibition can modulate the capacity to repair topoisomerase I-mediated DNA damage in the clinic...
  18. ncbi Phase I trial of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), a heat shock protein inhibitor, administered twice weekly in patients with advanced malignancies
    Shivaani Kummar
    Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA
    Eur J Cancer 46:340-7. 2010
    ....
  19. ncbi Plasma and cerebrospinal fluid pharmacokinetics of topotecan in a phase I trial of topotecan, tamoxifen, and carboplatin, in the treatment of recurrent or refractory brain or spinal cord tumors
    Robert J Morgan
    Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, 91010, USA
    Cancer Chemother Pharmacol 66:927-33. 2010
    ....
  20. ncbi Monitoring drug-induced gammaH2AX as a pharmacodynamic biomarker in individual circulating tumor cells
    Lihua H Wang
    Laboratory of Human Toxicology and Pharmacology, Science Applications International Corporation, Frederick, MD, USA
    Clin Cancer Res 16:1073-84. 2010
    ..Here, we describe an assay that directly examines changes in levels of the nuclear DNA damage marker gammaH2AX in individual CTCs of patients treated with chemotherapeutic agents...
  21. ncbi The statistics of phase 0 trials
    Larry V Rubinstein
    Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA
    Stat Med 29:1072-6. 2010
    ..The phase 0 trial promises to become an increasingly important tool for facilitating and speeding the development of new therapeutic agents, particularly in oncology...
  22. ncbi Phase I study of the synthetic triterpenoid, 2-cyano-3, 12-dioxoolean-1, 9-dien-28-oic acid (CDDO), in advanced solid tumors
    Giovanna Speranza
    Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA
    Cancer Chemother Pharmacol 69:431-8. 2012
    ....
  23. ncbi Poly(ADP-ribose) polymerase and XPF-ERCC1 participate in distinct pathways for the repair of topoisomerase I-induced DNA damage in mammalian cells
    Yong Wei Zhang
    Laboratory of Molecular Pharmacology, Center for Cancer Research, National Cancer Institute, National Institute of Health, Bethesda, MD 20892, USA
    Nucleic Acids Res 39:3607-20. 2011
    ..Our findings indicate the involvement of XPF-ERCC1 in inducing ?H2AX response and repairing topoisomerase I-induced DNA damage as an alternative pathway from PARP and tyrosyl-DNA phosphodiesterase 1...
  24. ncbi Phase II trial of carboplatin and infusional cyclosporine in platinum-resistant recurrent ovarian cancer
    Robert J Morgan
    Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, 1500 E Duarte Rd, Duarte, CA 91010, USA
    Cancer Chemother Pharmacol 54:283-9. 2004
    ....
  25. ncbi Feasibility and pharmacokinetic study of infusional dexrazoxane and dose-intensive doxorubicin administered concurrently over 96 h for the treatment of advanced malignancies
    Warren A Chow
    Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, 1500 E Duarte Rd, Duarte, CA 91010, USA
    Cancer Chemother Pharmacol 54:241-8. 2004
    ..Since delivery of doxorubicin by 96-h continuous intravenous infusion also reduces cardiac injury, we studied delivering dexrazoxane and doxorubicin concomitantly by prolonged intravenous infusion...
  26. ncbi Designing phase 0 cancer clinical trials
    Anthony J Murgo
    Division of Cancer Treatment and Diagnosis and Center for Cancer Research, National Cancer Institute, Bethesda, Maryland 20892 2440, USA
    Clin Cancer Res 14:3675-82. 2008
    ....
  27. ncbi Phase I trial of intraperitoneal docetaxel in the treatment of advanced malignancies primarily confined to the peritoneal cavity: dose-limiting toxicity and pharmacokinetics
    Robert J Morgan
    Division of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, California 91010, USA
    Clin Cancer Res 9:5896-901. 2003
    ..The purpose of this Phase I study was to determine the maximum tolerated dose and dose-limiting toxicities (DLTs) of i.p. docetaxel and to determine the peritoneal pharmacokinetics and pharmacological advantage of this agent...
  28. ncbi Expression of NADPH oxidase homologues and accessory genes in human cancer cell lines, tumours and adjacent normal tissues
    Agnes Juhasz
    Laboratory of Molecular Pharmacology, Center for Cancer Research, and Division of Cancer Treatment and Diagnosis, National Cancer Institute, NIH, Bethesda, MD, USA
    Free Radic Res 43:523-32. 2009
    ..The results demonstrate tumour-specific patterns of NOX gene expression that will inform further studies of the role of NOX activity in tumour cell invasion, growth factor response and proliferative potential...
  29. ncbi Phase I trial of MS-275, a histone deacetylase inhibitor, administered weekly in refractory solid tumors and lymphoid malignancies
    Shivaani Kummar
    Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland 20892, USA
    Clin Cancer Res 13:5411-7. 2007
    ..The aims of this phase I trial were to determine the dose-limiting toxicities and maximum tolerated dose of oral MS-275 in humans administered with food on a once weekly schedule and to study the pharmacokinetics of oral MS-275...
  30. ncbi Multihistology, target-driven pilot trial of oral topotecan as an inhibitor of hypoxia-inducible factor-1? in advanced solid tumors
    Shivaani Kummar
    Center for Cancer Research and Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 21702, USA
    Clin Cancer Res 17:5123-31. 2011
    ..We designed a pilot trial to measure HIF-1? inhibition in tumor biopsies from patients with advanced solid tumors overexpressing HIF-1?, after treatment with oral topotecan...
  31. ncbi Phase I trial of menadiol diphosphate (vitamin K3) in advanced malignancy
    Dean Lim
    Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, CA 91010, USA
    Invest New Drugs 23:235-9. 2005
    ..Plasma menadione concentrations peaked at 1.9-7.4 microM during the infusion in 3 patients receiving 1360 mg/m2. Further phase 1 and 2 combination trials using longer infusion durations have resulted from this trial...
  32. ncbi Quantification of chemotherapeutic target gene mRNA expression in human breast cancer biopsies: comparison of real-time reverse transcription-PCR vs. relative quantification reverse transcription-PCR utilizing DNA sequencer analysis of PCR products
    Agnes Juhasz
    Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, California 91010, USA
    J Clin Lab Anal 17:184-94. 2003
    ..By allowing the measurement of intratumoral target gene expression, these new methods may prove useful in predicting the clinical utility of gemcitabine- and platinum-containing chemotherapy programs in patients with solid tumors...
  33. ncbi Poly(ADP-ribose) polymerase inhibition enhances p53-dependent and -independent DNA damage responses induced by DNA damaging agent
    Diana Nguyen
    Division of Cancer Treatment and Diagnosis, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
    Cell Cycle 10:4074-82. 2011
    ..Abrogating the cell-cycle arrest induced by PARP inhibition plus chemotherapeutics may be a strategy in the treatment of BRCA-proficient cancer...
  34. ncbi Adenocarcinoma of the small bowel: changes in the landscape?
    Giovanna Speranza
    Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland 20892, USA
    Curr Opin Oncol 22:387-93. 2010
    ..In recent years, improved diagnostic imaging and an increase in reported experience with use of chemotherapy may alter the way we manage SBA. This review will summarize recent advances in characterization, imaging, and treatment of SBA...
  35. ncbi Analysis of Food and Drug Administration-approved anticancer agents in the NCI60 panel of human tumor cell lines
    Susan L Holbeck
    National Cancer Institute, Division of Cancer Treatment and Diagnosis, Developmental Therapeutics Program, Information Technology Branch, Bethesda, MD 20892, USA
    Mol Cancer Ther 9:1451-60. 2010
    ..These data are freely accessible to the public on the DTP website (http://dtp.cancer.gov/). The FDA-approved anticancer agents are themselves available from the NCI as a plated set of compounds for research use...
  36. ncbi Utilizing targeted cancer therapeutic agents in combination: novel approaches and urgent requirements
    Shivanni Kummar
    Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892, USA
    Nat Rev Drug Discov 9:843-56. 2010
    ....
  37. ncbi Histone gammaH2AX and poly(ADP-ribose) as clinical pharmacodynamic biomarkers
    Christophe E Redon
    Laboratory of Molecular Pharmacology, Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA
    Clin Cancer Res 16:4532-42. 2010
    ..We also discuss the choices of relevant samples for ?H2AX and PAR analyses...
  38. ncbi Phase II trial of bryostatin-1 in combination with cisplatin in patients with recurrent or persistent epithelial ovarian cancer: a California cancer consortium study
    Robert J Morgan
    Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, 1500 E Duarte Rd, Duarte, CA 91010, USA
    Invest New Drugs 30:723-8. 2012
    ....
  39. ncbi Neurophysiological study of peripheral neuropathy after high-dose Paclitaxel: lack of neuroprotective effect of amifostine
    Harry Openshaw
    Department of Neurology, City of Hope National Medical Center, Duarte, California 91010, USA
    Clin Cancer Res 10:461-7. 2004
    ..To determine if there is a beneficial effect of amifostine in preventing or reducing the neuropathy induced by high-dose paclitaxel...
  40. ncbi Cancer pharmacogenomics and pharmacoepidemiology: setting a research agenda to accelerate translation
    Andrew N Freedman
    National Cancer Institute, National Institutes of Health, Bethesda, MD 20892 7393, USA
    J Natl Cancer Inst 102:1698-705. 2010
    ....
  41. ncbi Role of Se-dependent glutathione peroxidases in gastrointestinal inflammation and cancer
    Fong Fong Chu
    Department of Medical Oncology and Therapeutics Research, Beckman Research Institute of City of Hope, Duarte, CA 91010 3000, USA
    Free Radic Biol Med 36:1481-95. 2004
    ..This review summarizes the current view of GPX in inflammation and cancer with emphasis on the GI tract...
  42. ncbi A phase I study of veliparib in combination with metronomic cyclophosphamide in adults with refractory solid tumors and lymphomas
    Shivaani Kummar
    National Cancer Institute, Bethesda, MD, USA
    Clin Cancer Res 18:1726-34. 2012
    ..We conducted a phase I trial of the PARP inhibitor veliparib and metronomic cyclophosphamide in patients with refractory solid tumors and lymphoid malignancies...
  43. ncbi Phase 0 clinical trials: conceptions and misconceptions
    Shivaani Kummar
    Center for Cancer Research, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland 20892, USA
    Cancer J 14:133-7. 2008
    ..We review here the fundamental requirements of clinical studies conducted under an exploratory IND and address some common misconceptions regarding oncologic phase 0 trials...
  44. ncbi Phase 0 clinical trials: recommendations from the Task Force on Methodology for the Development of Innovative Cancer Therapies
    Shivaani Kummar
    Center for Cancer Research, National Cancer Institute, NIH, Bethesda, MD 20892, USA
    Eur J Cancer 45:741-6. 2009
    ..Construction of a 'decision chart' was highly recommended to assist investigators and sponsors in determining whether an agent is suitable for evaluation in a Phase 0 trial...
  45. ncbi Phase I trial of vandetanib and bevacizumab evaluating the VEGF and EGF signal transduction pathways in adults with solid tumours and lymphomas
    Shivaani Kummar
    Center for Cancer Research, National Cancer Institute, 10 Center Drive, Bethesda, MD 20892, USA
    Eur J Cancer 47:997-1005. 2011
    ..We designed a phase I study to evaluate the combination of vandetanib, an investigational agent with activity against EGF receptor and VEGF receptor 2, and bevacizumab, a monoclonal antibody against VEGF...
  46. ncbi Phase I trial of fenretinide lym-x-sorb oral powder in adults with solid tumors and lymphomas
    Shivaani Kummar
    National Cancer Institute, Building 31, Room 3A44, 31 Center Drive, National Institutes of Health, Bethesda, MD 20892, USA
    Anticancer Res 31:961-6. 2011
    ..A novel lipid matrix, Lym-X-Sorb (LXS), was evaluated to improve fenretinide bioavailability and attain higher plasma concentrations...
  47. ncbi Compressing drug development timelines in oncology using phase '0' trials
    Shivaani Kummar
    Center for Cancer Research, SAIC Frederick, Inc, NCI Frederick, Frederick, Maryland, USA
    Nat Rev Cancer 7:131-9. 2007
    ..We expect that such trials will become a routine part of early-phase oncological drug development in the future...
  48. ncbi Phase I study of cisdiamminedichloroplatinum in combination with azidothymidine in the treatment of patients with advanced malignancies
    Robert J Morgan
    Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, 1500 E Duarte Rd, Duarte, CA 91010, USA
    Cancer Chemother Pharmacol 51:459-64. 2003
    ....
  49. ncbi AACR-FDA-NCI Cancer Biomarkers Collaborative consensus report: advancing the use of biomarkers in cancer drug development
    Samir N Khleif
    National Cancer Institute, Raritan, New Jersey, USA
    Clin Cancer Res 16:3299-318. 2010
    ....
  50. ncbi Drug development in oncology: classical cytotoxics and molecularly targeted agents
    Shivaani Kummar
    Medical Oncology Branch, Center for Cancer Research and Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA
    Br J Clin Pharmacol 62:15-26. 2006
    ..Thus, there is an increasing interest in making the best possible use of biomarkers and pharmacogenomics in early phases of drug development...
  51. ncbi Phase 0 trials: expediting the development of chemoprevention agents
    Shivaani Kummar
    Division of Cancer Treatment and Diagnosis, National Cancer Institute, NIH, Bethesda, MD 20892, USA
    Cancer Prev Res (Phila) 4:288-92. 2011
    ....
  52. ncbi Oxidative DNA base damage in MCF-10A breast epithelial cells at clinically achievable concentrations of doxorubicin
    Ewa Gajewski
    Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, 1500 E Duarte Road, Duarte, CA 91010, USA
    Biochem Pharmacol 73:1947-56. 2007
    ..Thus, clinically achievable concentrations of doxorubicin induce a level of oxidative stress in MCF-10A cells that is capable of oxidizing DNA bases and significantly altering cellular proliferation...
  53. ncbi Development of a validated immunofluorescence assay for ?H2AX as a pharmacodynamic marker of topoisomerase I inhibitor activity
    Robert J Kinders
    Laboratory of Human Toxicology and Pharmacology, Applied Developmental Research Support Directorate, Science Applications International Corporation Frederick, Inc, NationalCancer Institute Frederick, Frederick, MD 21702, USA
    Clin Cancer Res 16:5447-57. 2010
    ..A quantitative pharmacodynamic immunofluorescence assay for ?H2AX was developed, validated, and tested in human tumor xenograft models with the use of clinically relevant procedures...
  54. ncbi Preclinical modeling of a phase 0 clinical trial: qualification of a pharmacodynamic assay of poly (ADP-ribose) polymerase in tumor biopsies of mouse xenografts
    Robert J Kinders
    Laboratory of Human Toxicology and Pharmacology, Applied Developmental Research Support Directorate, Science Applications International Corporation Frederick, Inc, National Cancer Institute Frederick, Frederick, MD 21702, USA
    Clin Cancer Res 14:6877-85. 2008
    ..S. Food and Drug Administration's Exploratory Investigational New Drug Application. Performance of the study design, needle biopsy procedure, and validated pharmacodynamic assay were evaluated in human tumor xenograft models...
  55. ncbi A Phase I trial of 90Y-anti-carcinoembryonic antigen chimeric T84.66 radioimmunotherapy with 5-fluorouracil in patients with metastatic colorectal cancer
    Jeffrey Y C Wong
    Division of Radiation Oncology, Beckman Research Institute and City of Hope National Medical Center and Beckman Research Institute, Duarte, California 91010, USA
    Clin Cancer Res 9:5842-52. 2003
    ..The primary objective of this trial was to evaluate the feasibility and toxicities of systemic 90Y-chimeric T84.66 (cT84.66) anti-carcinoembryonic antigen RIT in combination with continuous infusion 5-fluorouracil (5-FU)...
  56. ncbi CCI-779 in metastatic melanoma: a phase II trial of the California Cancer Consortium
    Kim Margolin
    Division of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, California 91010, USA
    Cancer 104:1045-8. 2005
    ..CCI-779 is not immunosuppressive when administered on an intermittent schedule, and its toxicity is modest, consisting of nausea, diarrhea, hypertriglyceridemia, thrombocytopenia, asthenia, and follicular dermatitis...
  57. ncbi Phase I pharmacodynamic study of time and sequence dependency of hydroxyurea in combination with gemcitabine: a California Cancer Consortium Trial
    Yun Yen
    Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, 1500 East Duarte Road, Duarte, CA 91010 3000, USA
    Cancer Chemother Pharmacol 50:353-9. 2002
    ..We are presently developing a phase II trial of this regimen for patients with platinum-resistant head and neck cancer...
  58. ncbi Interspecies differences in plasma protein binding of MS-275, a novel histone deacetylase inhibitor
    Milin R Acharya
    Clinical Pharmacology Research Core, National Cancer Institute, Bethesda, MD 20892, USA
    Cancer Chemother Pharmacol 57:275-81. 2006
    ..376), rat (0.393), rabbit (0.355), dog (0.436), and pig (0.439) (P < 0.01), which may explain, in part, the species-dependent pharmacokinetic profile of MS-275 observed previously...
  59. ncbi Development and use of integral assays in clinical trials
    Richard L Schilsky
    University of Chicago, Chicago, IL, USA
    Clin Cancer Res 18:1540-6. 2012
    ..In this article we elaborate on the steps required to get a biomarker assay ready for use as an integral component of a clinical trial and give an example of the use of an integral assay in a phase III trial...
  60. ncbi Genome-wide depletion of replication initiation events in highly transcribed regions
    Melvenia M Martin
    Laboratory of Molecular Pharmacology, CCR, NCI, Bethesda, Maryland 20892, USA
    Genome Res 21:1822-32. 2011
    ..Data presented here identify replication initiation sites throughout the genome, providing a foundation for further analyses of DNA-replication dynamics and cell-cycle progression...
  61. ncbi Administration of oxaliplatin to patients with renal dysfunction: a preliminary report of the national cancer institute organ dysfunction working group
    Chris H Takimoto
    Medicine Branch at Navy, National Naval Medical Center, National Cancer Institute, Bethesda, MD, USA
    Semin Oncol 30:20-5. 2003
    ..These data suggest that dose reductions of single-agent oxaliplatin are not necessary in patients with CrCLs >20 mL/min...
  62. ncbi Bacteria-induced intestinal cancer in mice with disrupted Gpx1 and Gpx2 genes
    Fong Fong Chu
    Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, California, USA
    Cancer Res 64:962-8. 2004
    ..The sensitivity exhibited in these mice suggests that peroxidative stress plays an important role in ileal and colonic pathology and inflammation, which can lead to tumorigenesis...
  63. ncbi Molecular mechanism of adaphostin-mediated G1 arrest in prostate cancer (PC-3) cells: signaling events mediated by hepatocyte growth factor receptor, c-Met, and p38 MAPK pathways
    Indranil Mukhopadhyay
    Laboratory of Clinical Trials Unit, Division of Cancer Treatment and Diagnosis, NCI, National Institutes of Health, Bethesda, Maryland 20892, USA
    J Biol Chem 281:37330-44. 2006
    ..These findings suggest that the tyrphostin member has a broader spectrum of activity than originally predicted...
  64. ncbi Pharmacology of oxaliplatin in solid tumor patients with hepatic dysfunction: a preliminary report of the National Cancer Institute Organ Dysfunction Working Group
    James H Doroshow
    Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA 91010, USA
    Semin Oncol 30:14-9. 2003
    ....
  65. ncbi Tirapazamine plus carboplatin and paclitaxel in advanced malignant solid tumors: a california cancer consortium phase I and molecular correlative study
    Primo N Lara
    California Cancer Consortium at the University of California Davis Cancer Center, Sacramento, California 95817, USA
    Clin Cancer Res 9:4356-62. 2003
    ..We conducted a Phase I study of tirapazamine, carboplatin, and paclitaxel and assessed potential plasma markers of hypoxia as surrogates for response...
  66. ncbi Trastuzumab plus docetaxel in HER2/neu-positive non-small-cell lung cancer: a California Cancer Consortium screening and phase II trial
    Primo N Lara
    Division of Hematology Oncology, Department of Internal Medicine, University of California Davis Cancer Center, Sacramento, CA 95817, USA
    Clin Lung Cancer 5:231-6. 2004
    ..In view of the limited target population for HER2 inhibition, future efforts and resources should be directed toward molecular targets other than HER2 in NSCLC...
  67. ncbi Gemcitabine in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy: a phase II California cancer consortium trial
    Primo N Lara
    University of California Davis Cancer Center, Sacramento, CA 95817, USA
    Clin Lung Cancer 6:102-7. 2004
    ..06). We concluded that salvage gemcitabine in this dose and schedule is safe and tolerable in previously platinum-treated patients with NSCLC...
  68. ncbi Pharmacokinetics of cetuximab after administration of escalating single dosing and weekly fixed dosing in patients with solid tumors
    Antoinette R Tan
    The Cancer Institute of New Jersey, New Brunswick, New Jersey 08901, USA
    Clin Cancer Res 12:6517-22. 2006
    ..The purpose of this trial was to evaluate the pharmacokinetics of cetuximab given as a single dose followed by weekly fixed repeated dosing in patients with solid tumors...
  69. ncbi Concentrations of the DNA methyltransferase inhibitor 5-fluoro-2'-deoxycytidine (FdCyd) and its cytotoxic metabolites in plasma of patients treated with FdCyd and tetrahydrouridine (THU)
    Jan H Beumer
    Molecular Therapeutics Drug Discovery Program, University of Pittsburgh Cancer Institute, Pittsburgh, PA, 15213, USA
    Cancer Chemother Pharmacol 62:363-8. 2008
    ..We assessed plasma concentrations of FdCyd and metabolites in patients receiving FdCyd and THU...
  70. ncbi Sequential vinorelbine and docetaxel in advanced non-small cell lung cancer patients age 70 and older and/or with a performance status of 2: a phase II trial of the Southwest Oncology Group (S0027)
    Paul J Hesketh
    Caritas St. Elizabeth's Medical Center of Boston, Boston, MA, USA
    J Thorac Oncol 1:537-44. 2006
    ..CONCLUSION: Sequential vinorelbine and docetaxel is a well-tolerated and effective regimen in comparison with reports of other treatments tested in patients with advanced NSCLC age 70 and older and/or with a PS of 2...
  71. ncbi A randomized phase II trial of the matrix metalloproteinase inhibitor BMS-275291 in hormone-refractory prostate cancer patients with bone metastases
    Primo N Lara
    University of California Davis Cancer Center and the University of California Davis School of Medicine, Sacramento, California 95817, USA
    Clin Cancer Res 12:1556-63. 2006
    ..Serial serum and urine specimens were collected to assess for markers of bone metabolism...
  72. ncbi Phase I and pharmacokinetic study of imatinib mesylate in patients with advanced malignancies and varying degrees of liver dysfunction: a study by the National Cancer Institute Organ Dysfunction Working Group
    Ramesh K Ramanathan
    Translational Genomics Research Institute, 13208 E Shea Blvd, Ste 100, Scottsdale, AZ 85259, USA
    J Clin Oncol 26:563-9. 2008
    ..To develop dosing guidelines and to evaluate the pharmacokinetics of imatinib in patients with liver dysfunction (LD)...
  73. ncbi SU5416 plus interferon alpha in advanced renal cell carcinoma: a phase II California Cancer Consortium Study with biological and imaging correlates of angiogenesis inhibition
    Primo N Lara
    University of California Davis Cancer Center, Sacramento, California 95817, USA
    Clin Cancer Res 9:4772-81. 2003
    ..Efficacy was correlated with serial plasma VEGF and plasminogen activator inhibitor-1 levels and with positron emission tomography scans...
  74. ncbi A Phase II trial of flavopiridol (NSC #649890) in patients with previously untreated metastatic androgen-independent prostate cancer
    Glenn Liu
    Medical Oncology Section, Department of Medicine, University of Wisconsin Comprehensive Cancer Center, 600 Highland Avenue, Madison, WI 53792, USA
    Clin Cancer Res 10:924-8. 2004
    ..Its use in prostate cancer should be reserved for evaluation in combination therapies or alternative schedules...
  75. ncbi Oxaliplatin pharmacokinetics and pharmacodynamics in adult cancer patients with impaired renal function
    Chris H Takimoto
    Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, Texas 78245 3217, USA
    Clin Cancer Res 13:4832-9. 2007
    ..To characterize the pharmacokinetics and pharmacodynamics of oxaliplatin in cancer patients with impaired renal function...
  76. ncbi Trastuzumab plus docetaxel in HER-2/neu-positive prostate carcinoma: final results from the California Cancer Consortium Screening and Phase II Trial
    Primo N Lara
    Division of Hematology Oncology, Department of Internal Medicine, University of California Davis Cancer Center, Sacramento, California 95817, USA
    Cancer 100:2125-31. 2004
    ..The authors screened for HER-2 overexpression in patients developing hormone-refractory prostate carcinoma (HRPC) and conducted a Phase II trial of trastuzumab plus docetaxel in HER-2-positive patients...
  77. ncbi Mutant DNA in plasma of lung cancer patients: potential for monitoring response to therapy
    Tatsuo Kimura
    University of California, Davis Cancer Center, Sacramento, California 95817, USA
    Ann N Y Acad Sci 1022:55-60. 2004
    ..It was concluded that detection of tumor DNA in plasma is feasible using molecular techniques and that this approach shows promise for monitoring patient response to therapy...
  78. ncbi Intermittent dosing of the farnesyl transferase inhibitor tipifarnib (R115777) in advanced malignant solid tumors: a phase I California Cancer Consortium Trial
    Primo N Lara
    University of California, Davis Cancer Center, Sacramento, CA 95817, USA
    Anticancer Drugs 16:317-21. 2005
    ..Three of these prolonged stable disease patients had non-small cell lung cancer. We conclude that intermittent dosing of R115777 is feasible and tolerable. The recommended phase II dose is 600 mg orally b.i.d. on alternate weeks...
  79. ncbi Bortezomib plus docetaxel in advanced non-small cell lung cancer and other solid tumors: a phase I California Cancer Consortium trial
    Primo N Lara
    University of California, Davis Cancer Center, Sacramento, California 95817, USA
    J Thorac Oncol 1:126-34. 2006
    ..This phase I study was performed to determine the dose-limiting toxicity and maximum tolerated dose (MTD) of docetaxel in combination with bortezomib in patients with advanced non-small cell lung cancer (NSCLC) or other solid tumors...
  80. ncbi The cyclin-dependent kinase inhibitor UCN-01 plus cisplatin in advanced solid tumors: a California cancer consortium phase I pharmacokinetic and molecular correlative trial
    Primo N Lara
    University of California Davis Cancer Center, Sacramento, California 95817, USA
    Clin Cancer Res 11:4444-50. 2005
    ..Our group has previously shown that UCN-01 potentiates the apoptotic response of agents such as cisplatin in vitro by preventing sequence-specific abrogation of G2 arrest caused by DNA-damaging chemotherapies...
  81. ncbi Redox modulation of chemotherapy-induced tumor cell killing and normal tissue toxicity
    James H Doroshow
    J Natl Cancer Inst 98:223-5. 2006
  82. ncbi Phase 0 clinical trials in cancer drug development: from FDA guidance to clinical practice
    Robert Kinders
    Laboratory of Human Toxicology and Pharmacology, Applied Developmental Research Support Directorate, SAIC Frederick Inc, NCI Frederick, Frederick, Maryland 21702, USA
    Mol Interv 7:325-34. 2007
    ....