Last updated on December 2009

Capecitabine Irinotecan and Oxaliplatin in Treating Patients With Metastatic Cancer


Brief description of study

RATIONALE: Drugs used in chemotherapy, such as capecitabine, irinotecan, and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with irinotecan and oxaliplatin in treating patients with metastatic cancer.

Detailed Study Description

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.

Clinical Study Identifier: NCT00544063

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Recruitment Status: Open


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