A Phase I Trial of ZD1839 With Capecitabine in Patients With Advanced Solid Tumors (Formerly a Phase I Trial of ZD1839 With Capecitabine and Celecoxib)

NCT00039390 Phase 1 COMPLETED

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

Details

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	COMPLETED
Enrolment	41
Start date	2002-04

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

• capecitabine
• gefitinib
• pharmacological study
• laboratory biomarker analysis

Primary outcomes

• Maximum-tolerated dose (MTD) defined as the those below that results in dose-limiting toxicity (DLT) in >= 2 of 6 new patients, as assessed by CTCAE version 3.0 — 28 days
• DTL defined as any grade 3 or greater non-hematological toxicity, and grade 3 or greater skin rash, grade 4 thrombocytopenia and/or neutropenia as assessed by CTCAE version 3.0 — 28 days
• Pharmacological profile — At baseline, at 30 minutes, at 1, 2, 3, and 4 hours of days 8, 14, and 21 (course 1)

Countries

United States