A Phase I-II Study of Capecitabine and Oxaliplatin in Chemotherapy-Naive and Thymidylate Synthase Inhibitor Pretreated Advanced or Metastatic Colorectal Cancer
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.
Interventional
Primary Purpose: Treatment
Markus M. Borner, MD
Study Chair
University Hospital Inselspital, Berne
Switzerland: Swissmedic
SAKK 41/99
NCT00004187
June 1999
April 2004
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