A phase I and pharmacokinetic study of pemetrexed plus irinotecan in patients with advanced solid malignanciesEric K Rowinsky
Institute for Drug Development, Cancer Therapy, and Research Center, San Antonio, Texas, USA
Clin Cancer Res 13:532-9. 2007
..The study also sought to detect major pharmacokinetic drug-drug interactions between these agents and preliminary evidence of antitumor activity in patients with advanced solid malignancies...
- Targeted induction of apoptosis in cancer management: the emerging role of tumor necrosis factor-related apoptosis-inducing ligand receptor activating agents
Eric K Rowinsky
ImClone Systems, Branchburg, NJ 08876, USA
J Clin Oncol 23:9394-407. 2005
..The preclinical activity, the status of ongoing evaluations, and the potential clinical impact of these novel agents are reviewed...
Phase I and pharmacokinetic study of sequential paclitaxel and trabectedin every 2 weeks in patients with advanced solid tumorsQuincy Chu
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, Texas, USA
Clin Cancer Res 16:2656-65. 2010
..The study also sought to determine the maximum tolerated dose (MTD) level on this schedule, as well as to recommend doses for disease-directed studies...
- Phase I and pharmacokinetic study of cisplatin and troxacitabine administered intravenously every 28 days in patients with advanced solid malignancies
Chia Chi Lin
The Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX, USA
Cancer Chemother Pharmacol 65:167-75. 2009
....
- Phase I and pharmacokinetic study of pemetrexed administered every 3 weeks to advanced cancer patients with normal and impaired renal function
Alain C Mita
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX, 78229, USA
J Clin Oncol 24:552-62. 2006
..Additional studies are needed to define appropriate dosing for renally impaired patients receiving higher dose pemetrexed with vitamin supplementation...
- Phase I, pharmacokinetic, and biological study of erlotinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors
Amita Patnaik
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, Texas 78229, USA
Clin Cancer Res 12:7406-13. 2006
....
- Phase I and pharmacokinetic study of XRP6258 (RPR 116258A), a novel taxane, administered as a 1-hour infusion every 3 weeks in patients with advanced solid tumors
Alain C Mita
Institute for Drug Development, Cancer Therapy and Research Center and University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA
Clin Cancer Res 15:723-30. 2009
..v. infusion every 3 weeks. The study also sought to determine the maximum tolerated dose and the recommended dose, to describe the pharmacokinetic (PK) behavior of the compound, and to seek preliminary evidence of anticancer activity...
- A phase II, pharmacokinetic, and biologic study of semaxanib and thalidomide in patients with metastatic melanoma
Monica M Mita
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78229, USA
Cancer Chemother Pharmacol 59:165-74. 2007
....
- Phase I and pharmacokinetic study of pemetrexed with high-dose folic acid supplementation or multivitamin supplementation in patients with locally advanced or metastatic cancer
Chris H Takimoto
Institute for Drug Development at the Cancer Therapy and Research Center and University of Texas Health Science Center, San Antonio, Texas 78245 3217, USA
Clin Cancer Res 13:2675-83. 2007
..Pemetrexed plasma pharmacokinetics were evaluated for cycle 1...
- Phase I and pharmacokinetic study of trabectedin as a 1- or 3-hour infusion weekly in patients with advanced solid malignancies
Bahram Forouzesh
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX, USA
Clin Cancer Res 15:3591-9. 2009
..The study also sought to determine the maximum tolerated dose (MTD) levels of trabectedin on these schedules, as well as to recommend doses for disease-directed studies...
- Phase I trial of the novel mammalian target of rapamycin inhibitor deforolimus (AP23573; MK-8669) administered intravenously daily for 5 days every 2 weeks to patients with advanced malignancies
Monica M Mita
Cancer Therapy and Research Center, Institute for Drug Development, The University of Texas Health Science Center, San Antonio, TX, USA
J Clin Oncol 26:361-7. 2008
....
- Phase I and pharmacokinetic study of the oral fluoropyrimidine S-1 on a once-daily-for-28-day schedule in patients with advanced malignancies
Quincy Siu-Chung Chu
Institute for Drug Development, Cancer Therapy and Research Center and The University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229, USA
Clin Cancer Res 10:4913-21. 2004
....
- A phase I and pharmacokinetic study of Col-3 (Metastat), an oral tetracycline derivative with potent matrix metalloproteinase and antitumor properties
Samira Syed
Institute for Drug Development, Cancer Therapy and Research Center and University Health Science Center at San Antonio, San Antonio, Texas 78229, USA
Clin Cancer Res 10:6512-21. 2004
....
- Phase I study of paclitaxel poliglumex administered weekly for patients with advanced solid malignancies
Monica Mita
Cancer Therapy and Research Center, San Antonio, TX, USA
Cancer Chemother Pharmacol 64:287-95. 2009
..This study was designed to determine the MTD and pharmacology of PPX administered weekly to patients with solid malignancies...
- A phase I and pharmacokinetic study of lapatinib in combination with letrozole in patients with advanced cancer
Quincy S C Chu
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, Texas, USA
Clin Cancer Res 14:4484-90. 2008
....
- Phase I and pharmacokinetic study of tasidotin hydrochloride (ILX651), a third-generation dolastatin-15 analogue, administered weekly for 3 weeks every 28 days in patients with advanced solid tumors
Alain C Mita
Institute for Drug Development, Cancer Therapy and Research Center and University of Texas Health Science Center, San Antonio 78229, USA
Clin Cancer Res 12:5207-15. 2006
..v. infusion weekly for 3 weeks every 4 weeks...
- A phase I and pharmacokinetic study of SAM486A, a novel polyamine biosynthesis inhibitor, administered on a daily-times-five every-three-week schedule in patients with Advanced solid malignancies
Lillian L Siu
Cancer Therapy and Research Center, Institute for Drug Development, San Antonio, Texas 78229, USA
Clin Cancer Res 8:2157-66. 2002
..Pharmacodynamic assessment of tumoral tissues in 1 study patient demonstrated changes in the levels of polyamines and their biosynthetic enzymes consistent with SAMDC inhibition...
- Farnesyltransferase inhibitors and their potential in the treatment of breast carcinoma
Johann S de Bono
Institute for Drug Development, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA
Semin Oncol 30:79-92. 2003
..Randomized clinical studies investigating the clinical benefits of farnesyltransferase inhibition, with or without a taxane and trastuzumab, in patients with treatment-naive HER2-positive metastatic breast carcinoma are now warranted...
- Phase I study of E7820, an oral inhibitor of integrin alpha-2 expression with antiangiogenic properties, in patients with advanced malignancies
Monica Mita
Institute for Drug Development, Cancer Therapy and Research Center at the University of Texas Health Science Center, San Antonio, Texas, USA
Clin Cancer Res 17:193-200. 2011
..The starting dose of E7820 was 10 mg/d, which was increased to 20, 40, 70, 100, and 200 mg/d in cohorts of new patients...
- A phase I, pharmacokinetic, and biological study of the farnesyltransferase inhibitor tipifarnib in combination with gemcitabine in patients with advanced malignancies
Amita Patnaik
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, Texas 78229, USA
Clin Cancer Res 9:4761-71. 2003
..The study also sought to identify drug-drug pharmacokinetic interactions, evaluate effects on protein farnesylation, and seek preliminary evidence for clinical activity...
- A phase I and pharmacokinetic study of the nonpolyglutamatable thymidylate synthase inhibitor ZD9331 plus docetaxel in patients with advanced solid malignancies
Garry H Schwartz
Brooke Army Medical Center, San Antonio, TX, USA
Invest New Drugs 22:437-48. 2004
..Further studies with this regimen are warranted in tumor types that have demonstrated sensitivity to both agents...
- A phase I and pharmacokinetic study of ILX-295501, an oral diarylsulfonylurea, on a weekly for 3 weeks every 4-week schedule in patients with advanced solid malignancies
Bahram Forouzesh
Cancer Therapy and Research Center, Institute for Drug Development, San Antonio, Texas 78229, USA
Clin Cancer Res 9:5540-9. 2003
..The characteristics of the myelosuppressive effects of ILX-295501, the paucity of severe nonhematological toxicities, and preliminary antitumor activity warrant disease-directed evaluations of ILX-295501...
- A Phase I and pharmocokinetic study of exatecan mesylate administered as a protracted 21-day infusion in patients with advanced solid malignancies
Mitchell A Garrison
Brooke Army Medical Center, San Antonio, Texas 78229, USA
Clin Cancer Res 9:2527-37. 2003
..The MTD was defined for both minimally pretreated (MP) and heavily pretreated (HP) patients as the highest dose level at which the incidence of dose-limiting toxicity does not exceed 20%...
- Cantuzumab mertansine, a maytansinoid immunoconjugate directed to the CanAg antigen: a phase I, pharmacokinetic, and biologic correlative study
Anthony W Tolcher
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78229, USA
J Clin Oncol 21:211-22. 2003
..v.) once every 3 weeks and to seek evidence of antitumor activity...
- Phase I and pharmacokinetic study of 3'-C-ethynylcytidine (TAS-106), an inhibitor of RNA polymerase I, II and III,in patients with advanced solid malignancies
Lisa A Hammond-Thelin
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX, USA
Invest New Drugs 30:316-26. 2012
..This study was performed to principally evaluate the feasibility of administering TAS-106 as a bolus intravenous (IV) infusion every 3 weeks...
- A Phase I pharmacokinetic and biological correlative study of oblimersen sodium (genasense, g3139), an antisense oligonucleotide to the bcl-2 mRNA, and of docetaxel in patients with hormone-refractory prostate cancer
Anthony W Tolcher
Institute for Drug Development, Cancer Therapy, and Research Center, San Antonio, Texas 78229, USA
Clin Cancer Res 10:5048-57. 2004
....
- ING-1, a monoclonal antibody targeting Ep-CAM in patients with advanced adenocarcinomas
Johann S de Bono
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, Texas, USA
Clin Cancer Res 10:7555-65. 2004
....
- A phase I pharmacokinetic study of bexarotene with paclitaxel and carboplatin in patients with advanced non-small cell lung cancer (NSCLC)
Jordi Rodon
Institute for Drug Development, Cancer Therapy and Research Center at the University of Texas Health Science Center, San Antonio, TX, USA
Cancer Chemother Pharmacol 69:825-34. 2012
..The primary objective of this study was to determine whether repeated doses of bexarotene capsules affect pharmacokinetic parameters of paclitaxel or carboplatin in patients with advanced non-small cell lung cancer...
- Phase I and pharmacokinetic study of lapatinib in combination with capecitabine in patients with advanced solid malignancies
Quincy S C Chu
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX, USA
J Clin Oncol 25:3753-8. 2007
..This phase I trial (EGF10005) assessed the safety, optimally tolerated regimen (OTR), and pharmacokinetics of lapatinib and capecitabine in combination in patients with advanced solid malignancies...
- Phase I and pharmacokinetic study of sequences of the rebeccamycin analogue NSC 655649 and cisplatin in patients with advanced solid tumors
Alejandro D Ricart
Institute for Drug Development, Cancer Therapy and Research Center, and Department of Pharmacology, University of Texas Health Science Center at San Antonio 78229, USA
Clin Cancer Res 11:8728-36. 2005
..Major toxicologic and pharmacologic differences between the two sequences of drug administration were also assessed...
- A phase I and pharmacokinetic study of pegylated camptothecin as a 1-hour infusion every 3 weeks in patients with advanced solid malignancies
Eric K Rowinsky
Institute for Drug Development, Cancer Therapy, and Research Center, San Antonio, TX, USA
J Clin Oncol 21:148-57. 2003
..The study also sought to determine the maximum-tolerated dose (MTD) of PEG-CPT, characterize its pharmacokinetic behavior, and seek preliminary evidence of anticancer activity...
- Raf: a strategic target for therapeutic development against cancer
Muralidhar Beeram
University of Texas Health Science Center at San Antonio, San Antonio, TX, USA
J Clin Oncol 23:6771-90. 2005
....
- Phase I, pharmacokinetic and biological correlative study of OSI-7904L, a novel liposomal thymidylate synthase inhibitor, and cisplatin in patients with solid tumors
Alejandro D Ricart
Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA
Clin Cancer Res 14:7947-55. 2008
..To evaluate the safety and describe the pharmacokinetic profile of OSI-7904L, a novel liposomal thymidylate synthase inhibitor, in combination with cisplatin (CDDP) in adults with advanced solid tumors...
- A Phase I and pharmacokinetic study of squalamine, an aminosterol angiogenesis inhibitor
Desiree Hao
Institute for Drug Development, Cancer Therapy and Research Center and The University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229, USA
Clin Cancer Res 9:2465-71. 2003
..The purpose of this study was to assess the feasibility and characterize the pharmacokinetics of squalamine administered as a continuous i.v. infusion daily for 5 days every 3 weeks...
- Administration of CI-1033, an irreversible pan-erbB tyrosine kinase inhibitor, is feasible on a 7-day on, 7-day off schedule: a phase I pharmacokinetic and food effect study
Emiliano Calvo
Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA
Clin Cancer Res 10:7112-20. 2004
..Its tolerability and the biological relevance of concentrations achieved at the maximal tolerated dose warrant consideration of disease-directed evaluations. This intermittent treatment schedule can be used without regard to meals...
- Vascular endothelial growth factor receptor-1 in human cancer: concise review and rationale for development of IMC-18F1 (Human antibody targeting vascular endothelial growth factor receptor-1)
Jonathan D Schwartz
ImClone Systems Corporation, 33 ImClone Drive, Branchburg, NJ 08876, USA
Cancer 116:1027-32. 2010
..The preliminary results of phase 1 investigations have also indicated a favorable safety profile for IMC-18F1 at doses that confer antibody concentrations that are associated with relevant antitumor activity in preclinical models...
- Rationale for the development of IMC-3G3, a fully human immunoglobulin G subclass 1 monoclonal antibody targeting the platelet-derived growth factor receptor alpha
Gaurav D Shah
ImClone Systems Corporation, 33 ImClone Drive, Branchburg, NJ 08876, USA
Cancer 116:1018-26. 2010
..Currently, IMC-3G3 is being evaluated in early clinical development for patients with several types of solid malignancies...
- Effect of epidermal growth factor receptor mutations on the response to epidermal growth factor receptor tyrosine kinase inhibitors: target-based populations for target-based drugs
Emiliano Calvo
Institute for Drug Development, Cancer Therapy and Research Center and University of Texas Health Science Center at San Antonio, TX 78229, USA
Clin Lung Cancer 6:S35-42. 2004
..The result should be more efficient and scientifically founded clinical development strategies for rationally designed target-based therapeutic agents...
- Phase I, pharmacokinetic, and pharmacodynamic study of intravenously administered Ad5CMV-p53, an adenoviral vector containing the wild-type p53 gene, in patients with advanced cancer
Anthony W Tolcher
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78229, USA
J Clin Oncol 24:2052-8. 2006
....
- Phase I and pharmacokinetic study of AI-850, a novel microparticle hydrophobic drug delivery system for paclitaxel
Alain C Mita
Institute for Drug Development, Cancer Therapy and Research Center and University of Texas Health Science Center, San Antonio, Texas, USA
Clin Cancer Res 13:3293-301. 2007
..v. infusion without premedication every 3 weeks, determine the maximum tolerated dose and the phase II recommended dose of AI-850, study the pharmacokinetics of paclitaxel in this new formulation, and seek evidence of anticancer activity...
- Pharmacodynamic evaluation of the epidermal growth factor receptor inhibitor OSI-774 in human epidermis of cancer patients
Shazli N Malik
The University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA
Clin Cancer Res 9:2478-86. 2003
..On the basis of these findings and the relatively simple and reliable method to measure p27 expression, this biomarker appears to be the most promising and is being evaluated in Phase II studies as a predictor of clinical outcome...
- Challenges of developing therapeutics that target signal transduction in patients with gynecologic and other malignancies
Eric K Rowinsky
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78229, USA
J Clin Oncol 21:175s-186s. 2003
....
- A phase I and pharmacokinetic study of temsirolimus (CCI-779) administered intravenously daily for 5 days every 2 weeks to patients with advanced cancer
Manuel Hidalgo
Institute for Drug Development, Cancer Therapy and Research Center, Brook Army Medical Center, San Antonio, TX, USA
Clin Cancer Res 12:5755-63. 2006
..v. once daily for 5 days every 2 weeks to determine the maximum tolerated dose, toxicity profile, pharmacokinetics, and preliminary antitumor efficacy...
- A phase I study of pivaloyloxymethyl butyrate, a prodrug of the differentiating agent butyric acid, in patients with advanced solid malignancies
Amita Patnaik
Institute for Drug Development, Cancer Therapy and Research Center and The University of Texas Health Science Center at San Antonio, Texas 78229, USA
Clin Cancer Res 8:2142-8. 2002
..Additional disease-directed clinical evaluations of AN-9 are necessary to establish the breadth of its antitumor activity and to assess its role as an effective differentiating agent...
- A randomized phase I and pharmacological trial of sequences of 1,3-bis(2-chloroethyl)-1-nitrosourea and temozolomide in patients with advanced solid neoplasms
Lisa A Hammond
Cancer Therapy and Research Center, University of San Antonio Health Science Center at San Antonio, San Antonio, Texas, USA
Clin Cancer Res 10:1645-56. 2004
..The characteristics of the myelosuppressive effects of BCNU/TEM, the paucity of severe nonhematological toxicities, and antitumor activity at tolerable doses warrant disease-directed evaluations on this schedule...
- Novel agents that target tublin and related elements
Eric K Rowinsky
ImClone Systems Inc, Branchburg, NJ 08876, USA
Semin Oncol 33:421-35. 2006
..Besides taxanes with novel delivery systems and unique physicochemical characteristics, the epothilones and other natural products, as well as developmental therapeutics against new mitotic targets, will be reviewed...
The future of cytotoxic therapy: selective cytotoxicity based on biology is the keyJohann S de Bono
Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA
Breast Cancer Res 5:154-9. 2003
..It is hoped that these studies will support the identification of the molecules driving a tumor's growth, and the selection of the appropriate combination of targeted agents in the near future...
- Approaches to optimize the use of monoclonal antibodies to epidermal growth factor receptor
Emiliano Calvo
Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, 7979 Wurzbach Road, 4th Floor, Zeller Building, San Antonio, TX 78229, USA
Curr Oncol Rep 7:123-8. 2005
..This review highlights the results of current approaches for improvement of the therapeutic indices of these agents...
- Targeting FMS-related tyrosine kinase receptor 3 with the human immunoglobulin G1 monoclonal antibody IMC-EB10
Hagop Youssoufian
ImClone Systems Corporation, 33 ImClone Drive, Branchburg, NJ 08876, USA
Cancer 116:1013-7. 2010
..Future clinical trials will test these notions formally and will identify the most appropriate opportunities for this member of a new generation of antileukemic therapies...
- Development of rationally designed, target-based agents for the treatment of advanced colorectal cancer
Alain C Mita
Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, 4th Floor Zeller Building, 7979 Wurzbach Road, San Antonio, TX 78229, USA
Clin Colorectal Cancer 4:107-23. 2004
..It will also emphasize the complexity of these systems and the need to incorporate novel clinical development paradigms based on a thorough scientific understanding of these targets...
- Signal events: Cell signal transduction and its inhibition in cancer
Eric K Rowinsky
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, Texas 78229, USA
Oncologist 8:5-17. 2003
..However, responsiveness to these novel therapies is dependent on a multitude of factors that ultimately determine the robustness and quality of the downstream response...
- Clinical experience with monoclonal antibodies to epidermal growth factor receptor
Emiliano Calvo
Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, 7979 Wurzbach Road, 4th Floor, Zeller Building, San Antonio, TX 78229, USA
Curr Oncol Rep 7:96-103. 2005
..Other mAbs against EGFR, particularly panitumumab (ABX-EGF), h-R3, and EMD72000, are in advanced stages of clinical development...
- Therapeutics targeting signal transduction for patients with colorectal carcinoma
Johann S de Bono
Institute for Drug Development, Cancer Therapy and Research Center, 7979 Wurzbach Road, 4th Floor Zeller Building, San Antonio, TX 78229, USA
Br Med Bull 64:227-54. 2002
..Potential advantages and disadvantages of these different therapeutic modalities are discussed and future challenges for the evaluation of these targeted agents in the clinic is presented...
- Blockade of insulin-like growth factor type-1 receptor with cixutumumab (IMC-A12): a novel approach to treatment for multiple cancers
Eric K Rowinsky
Department of Clinical Research and Regulatory Affairs, ImClone Systems, a wholly owned subsidiary of Eli Lilly and Company, Bridgewater, NJ, USA
Curr Drug Targets 12:2016-33. 2011
..Herein, we review published preclinical and clinical data for cixutumumab and provide a comprehensive overview of selected clinical studies...
- Crossing the cancer cell membrane to improve clinical outcomes
Eric K Rowinsky
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, Texas 78229, USA
Oncologist 8:1-4. 2003
- Safety, pharmacokinetics, and activity of ABX-EGF, a fully human anti-epidermal growth factor receptor monoclonal antibody in patients with metastatic renal cell cancer
Eric K Rowinsky
Institute for Drug Development, Cancer Therapy and Research Center, 7979 Wurzbach Rd, 4th Floor, Zeller Building, San Antonio, TX 78229, USA
J Clin Oncol 22:3003-15. 2004
....
- Targeting the molecular target of rapamycin (mTOR)
Eric K Rowinsky
Institute for Drug Development, Cancer Therapy and Research Center, 7979 Wurzbach Road, 4th Floor Zeller Building, San Antonio, TX 78229, USA
Curr Opin Oncol 16:564-75. 2004
..The molecular target of rapamycin, which is a member of the phosphoinositide 3-kinase related kinase family and a central modulator of cell growth, is a unique and prime strategic target for anticancer therapeutic development...
- Curtailing the high rate of late-stage attrition of investigational therapeutics against unprecedented targets in patients with lung and other malignancies
Eric K Rowinsky
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, Texas, USA
Clin Cancer Res 10:4220s-4226s. 2004
..To validate the concept of RDTB therapeutics and to realize their full potential, radically different development, evaluation, and regulatory paradigms must be adopted...
- The ErbB receptor family: a therapeutic target for cancer
Johann S de Bono
Institute for Drug Development of the Cancer Therapy and Research Foundation and Division of Medical Oncology, The University of Texas Health Science Center at San Antonio, 7979 Wurzbach, San Antonio, TX 78229, USA
Trends Mol Med 8:S19-26. 2002
..Potential advantages and disadvantages of these different therapeutic modalities, as well as future challenges of evaluating ErbB-targeted agents in the clinic, are presented...
- A phase I and pharmacokinetic study of ecteinascidin-743 on a daily x 5 schedule in patients with solid malignancies
Miguel A Villalona-Calero
Institute for Drug Development, Cancer Therapy and Research Center, The University of Texas Health Science Center at San Antonio, 78229, USA
Clin Cancer Res 8:75-85. 2002
..v. infusion for 5 days every 3 weeks; (b) recommend a dose for Phase II studies; (c) characterize its pharmacokinetic behavior; and (d) seek preliminary evidence of anticancer activity...
- Anti-transforming growth factor beta receptor II antibody has therapeutic efficacy against primary tumor growth and metastasis through multieffects on cancer, stroma, and immune cells
Zhaojing Zhong
Department of Antibody Technology and Immunology, Clinical Research, and Research, ImClone Systems, New York, New York 10014, USA
Clin Cancer Res 16:1191-205. 2010
..We investigated the therapeutic efficacy of anti-TGFbeta receptor II (TGFbeta RII) antibody in controlling metastasis and tumor growth as well as enhancing antitumor immunity in preclinical tumor models...
- Troxacitabine, an L-stereoisomeric nucleoside analog, on a five-times-daily schedule: a phase I and pharmacokinetic study in patients with advanced solid malignancies
Johann S de Bono
Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, 8122 Datapoint Drive, Suite 700, San Antonio, TX 78229, USA
J Clin Oncol 20:96-109. 2002
..5 and 1.2 mg/m(2)/d for MP and HP patients, respectively. Broad disease-directed evaluations of troxacitabine on this schedule and possibly less frequent schedules are warranted...
- IMC-A12, a human IgG1 monoclonal antibody to the insulin-like growth factor I receptor
Eric K Rowinsky
Department of Clinical Research and Regulatory Affairs, ImClone Systems Incorporated, Branchburg, New Jersey 08876, USA
Clin Cancer Res 13:5549s-5555s. 2007
..The results with IMC-A12 to date suggest that it may be an effective therapeutic in a diverse array of oncologic indications...
- Review: monoclonal antibodies to the vascular endothelial growth factor receptor-2 in cancer therapy
Hagop Youssoufian
Clinical Affairs Department, ImClone Systems, Inc, Branchburg, New Jersey 08876, USA
Clin Cancer Res 13:5544s-5548s. 2007
..Here, we discuss the role of VEGFR-2 in cancer and ongoing efforts to develop highly specific monoclonal antibodies for cancer therapy...
- Erosion of the principal investigator role in a climate of industry dominance
Eric K Rowinsky
University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA
Eur J Cancer 41:2206-9. 2005
..This commentary discusses the impact of the pharmaceutical and biotechnology industries on the academic investigator, new challenges, and potential threats to optimal therapeutic development...
- Weekly topotecan: an alternative to topotecan's standard daily x 5 schedule?
Eric K Rowinsky
Institute for Drug Development, The Cancer Therapy and Research Center, The University of Texas Health Science Center, San Antonio, Texas, USA
Oncologist 7:324-30. 2002
..These preliminary data suggest that weekly topotecan is active; further evaluations are planned to confirm the activity and therapeutic index and to determine optimal dosing of a weekly schedule...
- The erbB family: targets for therapeutic development against cancer and therapeutic strategies using monoclonal antibodies and tyrosine kinase inhibitors
Eric K Rowinsky
Institute for Drug Development of the Cancer Therapy and Research Foundation, San Antonio, Texas, USA
Annu Rev Med 55:433-57. 2004
..Early clinical studies suggest that both approaches are well tolerated and can induce clinical activity in many common malignancies...
- A widening prospect: Imatinib and novel applications of targeted therapy
Eric K Rowinsky
Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78229, USA
Semin Oncol 31:1-3. 2004
- Inhibiting signal transduction: recent advances in the development of receptor tyrosine kinase and Ras inhibitors
Desiree Hao
Institute for Drug Development, Cancer Therapy and Research Center, 8122 Datapoint Drive, Suite 700, San Antonio, TX 78229 3264, USA
Cancer Invest 20:387-404. 2002
..cytotoxic manner. This review will discuss the rationale and application of inhibiting signal transduction using inhibitors of RTK and Ras as prototypes of this class of agents...
- Phase I study of EKB-569, an irreversible inhibitor of the epidermal growth factor receptor, in patients with advanced solid tumors
Charles Erlichman
Department of Oncology, Mayo Clinic, Rochester, MN 55902, USA
J Clin Oncol 24:2252-60. 2006
....
- Role of body surface area in dosing of investigational anticancer agents in adults, 1991-2001
Sharyn D Baker
Division of Experimental Therapeutics, The Sydney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD 21237, USA
J Natl Cancer Inst 94:1883-8. 2002
..We conclude that body surface area should not be used to determine starting doses of investigational agents in future phase I studies...
- Multicenter phase II and translational study of cetuximab in metastatic colorectal carcinoma refractory to irinotecan, oxaliplatin, and fluoropyrimidines
Heinz-Josef Lenz
Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA
J Clin Oncol 24:4914-21. 2006
..The severity of rash was related to efficacy. Neither EGFR kinase domain mutations nor EGFR gene amplification appear to be essential for response to cetuximab in this setting...
- ZD1839, a selective oral epidermal growth factor receptor-tyrosine kinase inhibitor, is well tolerated and active in patients with solid, malignant tumors: results of a phase I trial
Malcolm Ranson
Christie Hospital and Royal Eye Hospital, Manchester, United Kingdom
J Clin Oncol 20:2240-50. 2002
..To investigate the tolerability, pharmacokinetics, and antitumor activity of the oral, selective epidermal growth factor receptor-tyrosine kinase inhibitor ZD1839 in patients with solid malignant tumors...
- Two drug interaction studies evaluating the pharmacokinetics and toxicity of pemetrexed when coadministered with aspirin or Ibuprofen in patients with advanced cancer
Christopher J Sweeney
Indiana University Cancer Center, Indianapolis, IN, USA
Clin Cancer Res 12:536-42. 2006
....
- Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193)
George W Sledge
Cancer Pavillion, Indiana University Medical Center, 535 Barnhill Drive, Room RT473, Indianapolis, IN 46202 5112, USA
J Clin Oncol 21:588-92. 2003
..Patients receiving single-agent doxorubicin or paclitaxel were crossed over to the other agent at time of progression...
- Progress in the management of gynecologic cancer: consensus summary statement
Stephen A Cannistra
Department of Gynecologic Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Brigham and Women's Hospital, Dana-Farber Cancer Institute, and Massachusetts General Hospital, Boston, USA
J Clin Oncol 21:129s-132s. 2003
- Phase 1 study of weekly polyethylene glycol-camptothecin in patients with advanced solid tumors and lymphomas
James A Posey
University of Alabama at Birmingham Comprehensive Cancer Center, 35294, USA
Clin Cancer Res 11:7866-71. 2005
..To determine the maximal tolerated dose and dose-limiting toxicities (DLT) of pegamotecan (polyethylene glycol-camptothecin) in patients with advanced malignancies when administered in cycles of once weekly for 3 of 4 weeks...
- Evaluation of alternate size descriptors for dose calculation of anticancer drugs in the obese
Alex Sparreboom
Department of Medical Oncology, Erasmus MC Daniel den Hoed Cancer Center, Rotterdam, The Netherlands
J Clin Oncol 25:4707-13. 2007
..Here, we assessed the pharmacokinetics of eight anticancer drugs in adults and evaluated the potential utility of alternative weight descriptors in dose calculation for the obese...
- A phase I and pharmacologic study of pyrazoloacridine and cisplatin in patients with advanced cancer
E Claire Dees
Division of Hematology and Oncology, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Invest New Drugs 21:75-84. 2003
..Pharmacokinetic analysis showed that sequence does not impact on the pharmacokinetics of PZA when given in combination with cisplatin...
- The multifunctional, multi-institutional, and sometimes even global phase I study: a better life for phase I evaluations or just "living large"?
Anthony W Tolcher
J Clin Oncol 20:4276-8. 2002
- The alkylating agent penclomedine induces degeneration of purkinje cells in the rat cerebellum
Robert F Struck
Department of Oncology, The Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA
Invest New Drugs 21:269-79. 2003
....
- Quality of life in head and neck cancer patients after treatment with high-dose radiotherapy alone or in combination with cetuximab
Desmond Curran
Omega Research, Dublin, Ireland
J Clin Oncol 25:2191-7. 2007
..In this randomized, phase III study, quality of life (QoL) was assessed in patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN) after high-dose radiotherapy alone or in combination with cetuximab...
- The molecular target of rapamycin (mTOR) as a therapeutic target against cancer
Monica M Mita
Institute for Drug Development Cancer Therapy and Research Center San Antonio, Texas 78229, USA
Cancer Biol Ther 2:S169-77. 2003
..The preliminary results of early clinical evaluations with RAP analogs and the unique developmental challenges that lie ahead will also be discussed...
- Population pharmacokinetic and adverse event analysis of topotecan in patients with solid tumors
Diane R Mould
Projections Research Inc, 535 Springview Lane, Phoenixville, PA 19460, USA
Clin Pharmacol Ther 71:334-48. 2002
..The use of covariates to individualize dose would result in less variability in exposure, reducing the likelihood of severe neutropenia and potentially improving treatment benefit...
- Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck
James A Bonner
Department of Medicine, University of Alabama, Birmingham, USA
N Engl J Med 354:567-78. 2006
....
- Preclinical and clinical evaluations of ABX-EGF, a fully human anti-epidermal growth factor receptor antibody
Kenneth A Foon
Abgenix, Inc, Fremont, CA, USA
Int J Radiat Oncol Biol Phys 58:984-90. 2004
..Therapy was generally well tolerated without statistically significant adverse events. Monoclonal antibody blockade of EGFR represents a new and exciting direction in cancer therapy...
- Taxane analogues: distinguishing royal robes from the "Emperor's New Clothes"
Eric K Rowinsky
Clin Cancer Res 8:2759-63. 2002
- Novel anticancer agents in clinical development
Alex A Adjei
Mayo Clinic and Foundation Rochester, Minnesota 55905, USA
Cancer Biol Ther 2:S5-15. 2003
..This review will highlight promising rationally designed, target-based agents in clinical development, as well as the unique challenges involved in their successful development...
