Spots Global Cancer Trial Database for Gefitinib and Capecitabine in Treating Patients With Advanced Solid Tumors

Study Description

Brief Summary: This phase I trial is studying the side effects and best dose of gefitinib and capecitabine in treating patients with advanced solid tumors. Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib and capecitabine may kill more tumor cells

Detailed Description: OBJECTIVES: I. Determine the maximum tolerated dose of gefitinib and capecitabine in patients with advanced solid tumors. II. Determine the dose-limiting toxic effects of this regimen in these patients. III. Determine the pharmacologic profile of this regimen in these patients. OUTLINE: This is a dose-escalation study of gefitinib and capecitabine. Patients receive oral gefitinib once daily on days 1-14 and oral capecitabine twice daily on days 8-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gefitinib and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 11-41 patients will be accrued for this study within 2.5 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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