1. A National Cancer Institute of Canada Clinical Trials Group Study – IND.135: Phase I/II study of irinotecan (camptosar), oxaliplatin and raltitrexed (tomudex) (COT) in patients with advanced colorectal cancer
- Author
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Lesley Seymour, Rakesh Goel, Mark Vincent, Barbara Fisher, Walter Kocha, G. Chiritescu, C. Cripps, J. Maroun, Derek J. Jonker, D. Lister, and A. Malpage
- Subjects
Adult ,Male ,Canada ,Cancer Research ,medicine.medical_specialty ,Maximum Tolerated Dose ,Organoplatinum Compounds ,Colorectal cancer ,Nausea ,Thiophenes ,Irinotecan ,Gastroenterology ,Cohort Studies ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Aged ,business.industry ,Combination chemotherapy ,Middle Aged ,medicine.disease ,Discontinuation ,Oxaliplatin ,Surgery ,Clinical trial ,Treatment Outcome ,Oncology ,Quinazolines ,Camptothecin ,Female ,medicine.symptom ,Colorectal Neoplasms ,business ,Raltitrexed ,medicine.drug - Abstract
Thirty-one patients with metastatic colorectal cancer were enrolled in this phase I/II trial of a triple combination of camptosar (C), oxaliplatin (O) and tomudex (T), all given on day one of a convenient three-week schedule. Patients received 257 cycles (1–18) in five cohorts. Toxicity was manageable and haematological toxicity was mild to moderate. Diarrhoea was the main dose-limiting toxicity; nausea and vomiting were common. Fatigue was frequent, moderate in severity and a reason for discontinuation in some patients. The recommended phase II doses were (C) 220 mg/m 2 , (O) 100 mg/m 2 , (T) 2.75 mg/m 2 . A 50% response rate in 30 evaluable patients was confirmed by an independent radiology review board; progression-free survival and overall median survival were 7.3 months and 16.6 months, respectively. Of the 16 patients treated at the recommended dose, 9 (56.3%) experienced partial response. Further evaluation in a randomized study compared to sequential doublets is warranted. Triple combinations could be relevant in curative settings for high-risk patients.
- Published
- 2006
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