Phase I Study Evaluating the Feasibility of Chemotherapy With Capecitabine, Irinotecan, and Oxaliplatin in Patients With Metastatic Carcinoma
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicities of capecitabine.
Secondary
- Determine the recommended phase II dose of capecitabine.
- Define the toxicity profile.
- Evaluate potential antitumor activity in terms of objective response, duration of
response, and time to disease progression.
- Evaluate the pharmacokinetic profile of capecitabine and irinotecan hydrochloride.
OUTLINE: This is a dose-escalation study of capecitabine conducted in two parts.
- Part I: Patients receive irinotecan hydrochloride IV over 90 minutes on day 1 and oral
capecitabine twice daily on days 1-7. Treatment repeats every 2 weeks for up to 6
months in the absence of disease progression or unacceptable toxicity.
Cohorts of up to 6 patients receive escalating doses (up to 5 dosages) of capecitabine. The
maximum tolerated dose (MTD) is defined as the dose at which 50% of patients experience
toxicity during the first 2 courses of therapy.
- Part II: Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV
over 90 minutes on day 1 and oral capecitabine on days 1-7. Treatment repeats every 2
weeks for up to 6 months in the absence of disease progression or unacceptable
toxicity.
Cohorts of up to 6 patients receive escalating doses (up to 7 dosages) of capecitabine. The
MTD is defined as in part I.
Interventional
Allocation: Non-Randomized, Primary Purpose: Treatment
Maximum tolerated dose of capecitabine
Yes
Marc Ychou, MD, PhD
Centre Val d'Aurelle - Paul Lamarque
Unspecified
CDR0000564073
NCT00544063
October 2006
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