Capecitabine and Oxaliplatin in Treating Patients With Advanced or Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine and oxaliplatin in treating patients who have advanced or metastatic colorectal cancer that cannot be surgically removed.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I-II Study of Capecitabine and Oxaliplatin in Chemotherapy-Naive and Thymidylate Synthase Inhibitor Pretreated Advanced or Metastatic Colorectal Cancer|
|Study Start Date:||June 1999|
|Study Completion Date:||April 2004|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the maximum tolerated dose of capecitabine when combined with oxaliplatin in patients with chemotherapy naive or thymidylate synthase inhibitor pretreated unresectable, advanced or metastatic colorectal cancer. II. Determine the safety profile, toxicity, and efficacy of this regimen in these patients. III. Determine the complete and partial remission rates, time to treatment failure, and overall survival of patients treated with this regimen.
OUTLINE: This is a dose escalation, multicenter study of capecitabine. Patients are stratified by pretreatment status (any pretreatment vs chemotherapy naive vs thymidylate synthase inhibitor pretreatment). Phase I : Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine every 12 hours on days 1-14. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which 2 or more of 6 patients experience dose limiting toxicity. Phase II: Patients receive capecitabine at the feasible dose. The feasible dose is defined as the dose immediately preceding the MTD from phase I. Patients are followed every 3 months for 1 year, and then every 6 months thereafter until death.
PROJECTED ACCRUAL: Approximately 18 patients will be accrued for phase I of the study and a total of 27-68 patients (14-25 thymidylate synthase inhibitor pretreated patients and 13-43 chemotherapy naive patients) will be accrued for phase II of the study.