L K Seymour
Affiliation: Queen's University
- The design of clinical trials for new molecularly targeted compounds: progress and new initiativesLesley Seymour
National Cancer Institute of Canada Clinical Trials Group, Queens University, 18 Barrie Street, Kingston, Ontario, K7L 3N6, Canada
Curr Pharm Des 8:2279-84. 2002..Progress in this area of early trial design are reviewed...
- Tumor shrinkage and objective response rates: gold standard for oncology efficacy screening trials, or an outdated end point?Penelope Bradbury
From the NCIC Clinical Trials Group, Queen s University, Kingston, Ontario, Canada
Cancer J 15:354-60. 2009..We review here the historical and current information regarding objective tumor response...
- Impact of the 2010 Consensus Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering CommitteeLesley Seymour
NCIC Clinical Trials Group, Kingston, Ontario
Clin Cancer Res 21:5057-63. 2015..Clin Cancer Res; 21(22); 5057-63. ©2015 AACR. ..
- Design and conduct of early clinical studies of two or more targeted anticancer therapies: recommendations from the task force on Methodology for the Development of Innovative Cancer TherapiesLesley K Seymour
NCIC Clinical Trials Group, Kingston, Canada
Eur J Cancer 49:1808-14. 2013....
- The design of phase II clinical trials testing cancer therapeutics: consensus recommendations from the clinical trial design task force of the national cancer institute investigational drug steering committeeLesley Seymour
NCIC Clinical Trials Group, Kingston, Ontario, Canada
Clin Cancer Res 16:1764-9. 2010..The design of any clinical trial should always be carefully evaluated and justified based on characteristic specific to the situation...
- A review of dose-limiting events in phase I trials: antimetabolites show unpredictable relationships between dose and toxicityL Seymour
Investigational New Drug Program, National Cancer Institute of Canada Clinical Trial Group, Queens University, Kingston, Ontario
Cancer Chemother Pharmacol 47:2-10. 2001..To determine if this was a general phenomenon, we undertook a review of the results of a large group of phase I trials of cytotoxic agents...
- Epidermal growth factor receptor inhibitors: an update on their development as cancer therapeuticsLesley Seymour
National Cancer Institute of Canada Clinical Trials Group, Queens University, Kingston, Ontario, K7L3N6, Canada
Curr Opin Investig Drugs 4:658-66. 2003..Early data suggest a number of potential roles for these agents in the modulation of resistance and in combination with other inhibitors of signal transduction...
- Epidermal growth factor receptor as a target: recent developments in the search for effective new anti-cancer agentsL K Seymour
Investigational New Drug Program, National Cancer Institute of Canada Clinical Trials Group, Queens University, Kingston, Ontario, Canada
Curr Drug Targets 2:117-33. 2001..Although these new compounds offer exciting opportunities, they bring with them real challenges in terms of the selection of appropriate trial designs as well as surrogate endpoints...
- Clinical predictive value of the in vitro cell line, human xenograft, and mouse allograft preclinical cancer modelsTheodora Voskoglou-Nomikos
National Cancer Institute of Canada Clinical Trials Group, Cancer Clinical Trials Division, Cancer Research Institute, Queen s University, 10 Stuart Street, Kingston, Ontario, K7L 3N6 Canada
Clin Cancer Res 9:4227-39. 2003..We looked at the value of three preclinical cancer models, the in vitro human cell line, the human xenograft, and the murine allograft, to examine whether they are reliable in predicting clinical utility...
- Economic analysis: randomized placebo-controlled clinical trial of erlotinib in advanced non-small cell lung cancerPenelope A Bradbury
NCIC Clinical Trials Group, Kingston, ON, Canada
J Natl Cancer Inst 102:298-306. 2010..We undertook an economic analysis of erlotinib treatment in this trial and explored different molecular and clinical predictors of outcome to determine the cost-effectiveness of treating various populations with erlotinib...
- Alternate endpoints for screening phase II studiesNeesha Dhani
Princess Margaret Hospital, Toronto, Ontario, Canada
Clin Cancer Res 15:1873-82. 2009..Alternate endpoints, although promising, require additional evaluation and prospective validation before their use as a primary endpoint for phase II trials...
- Objective responses in patients with malignant melanoma or renal cell cancer in early clinical studies do not predict regulatory approvalJohn Goffin
National Cancer Institute of Canada Clinical Trials Group, Queen s University, Kingston, Ontario, Canada
Clin Cancer Res 11:5928-34. 2005..Given that spontaneous regressions are observed in melanoma and renal cell carcinoma, this study assessed whether tumor responses, particularly in these two tumor types, predict for future regulatory drug approval...
- Symptom improvement in lung cancer patients treated with erlotinib: quality of life analysis of the National Cancer Institute of Canada Clinical Trials Group Study BR.21Andrea Bezjak
Princess Margaret Hospital University Health Network, University of Toronto, Toronto, Ontario, Canada
J Clin Oncol 24:3831-7. 2006..This report describes the quality of life (QOL) findings of a randomized placebo controlled study of erlotinib, an epidermal growth factor receptor inhibitor, in patients with non-small-cell lung cancer (NSCLC)...
- Prognostic and predictive gene signature for adjuvant chemotherapy in resected non-small-cell lung cancerChang Qi Zhu
University Health Network, Ontario Cancer Institute and Princess Margaret Hospital, University of Toronto, Toronto, Ontario, Canada
J Clin Oncol 28:4417-24. 2010..10 trial demonstrated benefit from adjuvant cisplatin/vinorelbine (ACT) in early-stage non-small-cell lung cancer (NSCLC). We hypothesized that expression profiling may identify stage-independent subgroups who might benefit from ACT...
- Phase I and pharmacokinetic study of Bay 38-3441, a camptothecin glycoconjugate, administered as a 30-minute infusion daily for five days every 3 weeks in patients with advanced solid malignanciesEric X Chen
National Cancer Institute of Canada, Clinical Trials Group, Kingston, Ontario, Canada
Invest New Drugs 23:455-65. 2005..Bay 38-3441 was well tolerated in this study with granulocytopenia as the main hematologic toxicity. This study showed that glycoconjugation is a feasible delivery technique for camptothecin...
- Inhibitors of epidermal-growth-factor receptors: a review of clinical research with a focus on non-small-cell lung cancerSrikala S Sridhar
Division of Medical Oncology, Department of Medicine of the University Health Network, Princess Margaret Hospital and the University of Toronto, Canada
Lancet Oncol 4:397-406. 2003....
- Role of KRAS and EGFR as biomarkers of response to erlotinib in National Cancer Institute of Canada Clinical Trials Group Study BR.21Chang Qi Zhu
FRCPC, Princess Margaret Hospital, 610 University Ave, Toronto, Ontario, Canada M5G 2M9
J Clin Oncol 26:4268-75. 2008..To evaluate the effect of KRAS and epidermal growth factor receptor (EGFR) genotype on the response to erlotinib treatment in the BR.21, placebo-controlled trial...
- Pooled analysis of the effect of age on adjuvant cisplatin-based chemotherapy for completely resected non-small-cell lung cancerMartin Fruh
Department of Medical Oncology, Princess Margaret Hospital, Toronto
J Clin Oncol 26:3573-81. 2008..This pooled analysis was undertaken to assess the efficacy and toxicity of adjuvant cisplatin-based chemotherapy in elderly patients with non-small-cell lung cancer (NSCLC)...
- Phase I and pharmacokinetic study of novel L-nucleoside analog troxacitabine given as a 30-minute infusion every 21 daysKarl Belanger
Centre Hospitalier de l Universite de Montreal CHUM, Hopital Notre Dame, 1560 Sherbrooke Street East, Montreal, Quebec, Canada H2L 4M1 corrected
J Clin Oncol 20:2567-74. 2002..We conducted a phase I study of troxacitabine given as a 30-minute infusion once every 21 days...
- A clinical prognostic index for patients treated with erlotinib in National Cancer Institute of Canada Clinical Trials Group study BR.21Marie Florescu
Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Hospital Site and University of Toronto, Toronto, Canada
J Thorac Oncol 3:590-8. 2008..BR.21 demonstrated significant survival benefit for non-small cell lung cancer patients receiving erlotinib compared with placebo. We undertook to characterize, by exploratory subset analysis, patients less likely to benefit from erlotinib...
- Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative GroupJean Pierre Pignon
Institut Gustave Roussy, 39 rue Camille Desmoulins, 94805 Villejuif, France
J Clin Oncol 26:3552-9. 2008..The aim of the Lung Adjuvant Cisplatin Evaluation was to identify treatment options associated with a higher benefit or groups of patients who particularly benefit from postoperative chemotherapy...
- Erlotinib for advanced non-small-cell lung cancer in the elderly: an analysis of the National Cancer Institute of Canada Clinical Trials Group Study BR.21Paul Wheatley-Price
Department of Medical Oncology, Princess Margaret Hospital, 610 University Ave, Toronto, Ontario, M5G 2M9 Canada
J Clin Oncol 26:2350-7. 2008..21 established erlotinib as a standard of care in patients with non-small-cell lung cancer (NSCLC) after failure of first- or second-line chemotherapy. The current study analyzes the influence of age on outcomes in BR.21...
- A phase II and pharmacokinetic study of SB-715992, in patients with metastatic hepatocellular carcinoma: a study of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG IND.168)Jennifer J Knox
Princess Margaret Hospital University Health Network, University of Toronto, Toronto, ON, Canada M5G 2M9
Invest New Drugs 26:265-72. 2008..Among these patients with preserved hepatic function and good performance status, SB-715992 was generally well tolerated. However, no conclusive evidence of benefit was seen with SB-715992 monotherapy in HCC...
- A pharmacodynamic study of the epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in metastatic colorectal cancer patientsManijeh Daneshmand
Ottawa Regional Cancer Centre, Ottawa, Ontario, K1H 1C4 Canada
Clin Cancer Res 9:2457-64. 2003..Immunohistochemistry for EGFR, activated EGFR, phosphorylated Akt, phosphorylated ERK, p27(Kip1), and beta-catenin was also performed...
- Prospective, randomized, double-blind, placebo-controlled trial of marimastat after response to first-line chemotherapy in patients with small-cell lung cancer: a trial of the National Cancer Institute of Canada-Clinical Trials Group and the European OrgaFrances A Shepherd
National Cancer Institute of Canada Clinical Trials Group
J Clin Oncol 20:4434-9. 2002..This trial was undertaken to determine whether adjuvant treatment with the metalloproteinase inhibitor marimastat could prolong survival in responding patients with SCLC after chemotherapy...
- A phase II trial of ZD1839 (Iressa) 750 mg per day, an oral epidermal growth factor receptor-tyrosine kinase inhibitor, in patients with metastatic colorectal cancerMary J Mackenzie
Hamilton Regional Cancer Centre, 699 Concession St, Hamilton, ON, Canada L8V 5C2
Invest New Drugs 23:165-70. 2005....
- Phase I study of the multidrug resistance inhibitor zosuquidar administered in combination with vinorelbine in patients with advanced solid tumoursLyly H Le
Princess Margaret Hospital, 610 University Ave, Toronto, ON, M5G 2M9, Canada
Cancer Chemother Pharmacol 56:154-60. 2005..This phase I study was designed to determine the maximum tolerated dose (MTD) of zosuquidar in combination with vinorelbine. The effects of zosuquidar on vinorelbine pharmacokinetics were also examined...
- Erlotinib in previously treated non-small-cell lung cancerFrances A Shepherd
Department of Medical Oncology, University Health Network, Princess Margaret Hospital Site, University of Toronto, Canada
N Engl J Med 353:123-32. 2005....
- Erlotinib in lung cancer - molecular and clinical predictors of outcomeMing Sound Tsao
University Health Network, Princess Margaret Hospital Site, and the Ontario Cancer Institute, University of Toronto, Canada
N Engl J Med 353:133-44. 2005....
- Chemotherapy-induced neutropenia and treatment efficacy in advanced non-small-cell lung cancer: a pooled analysis of three randomised trialsMassimo Di Maio
National Cancer Institute, Naples, Italy
Lancet Oncol 6:669-77. 2005..We aimed to assess whether haematological toxic effects could be a biological measure of drug activity and a marker of efficacy...
- A phase I study of T900607 given once every 3 weeks in patients with advanced refractory cancers; National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) IND 130Karen A Gelmon
British Columbia Cancer Agency, Vancouver Cancer Centre, Vancouver, BC, Canada, V5Z 4E6
Invest New Drugs 23:445-53. 2005..This phase I trial was conducted to determine the maximum tolerated dose, recommended phase II dose, pharmacokinetic properties and toxicities of this agent...
- Clinical utility of epidermal growth factor receptor expression for selecting patients with advanced non-small cell lung cancer for treatment with erlotinibGary M Clark
OSI Pharmaceuticals, Inc, Boulder, CO 80301, USA
J Thorac Oncol 1:837-46. 2006..Because not all patients benefit from erlotinib, epidermal growth factor receptor (EGFR) protein expression may provide a basis for selecting patients for treatment with this EGFR inhibitor...
- A phase II study of ispinesib (SB-715992) in patients with metastatic or recurrent malignant melanoma: a National Cancer Institute of Canada Clinical Trials Group trialChristopher W Lee
BC Cancer Agency Fraser Valley Centre, 13750 96th Avenue, Surrey, BC, Canada V3V 1Z2
Invest New Drugs 26:249-55. 2008..Although KSP expression appears to be common in melanoma, KSP may not be a suitable target for its treatment...
- Smoking history and epidermal growth factor receptor expression as predictors of survival benefit from erlotinib for patients with non-small-cell lung cancer in the National Cancer Institute of Canada Clinical Trials Group study BR.21Gary M Clark
OSI Pharmaceuticals, Inc, Boulder, CO 80301, USA
Clin Lung Cancer 7:389-94. 2006..21, a randomized double-blind study of 731 patients with advanced-stage non-small-cell lung cancer...