Gefitinib and Capecitabine in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Capecitabine; Gefitinib

Criteria

Inclusion Criteria:

• Histologically confirmed advanced solid tumor that is refractory to standard therapy or for which no standard therapy exists

• No uncontrolled brain metastases, including symptomatic lesions or lesions requiring treatment (e.g., glucocorticoids and/or anticonvulsants)

• Performance status - ECOG 0-2

• At least 12 weeks

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9 g/dL

• Bilirubin no greater than 1.5 mg/dL

• AST and ALT no greater than 2.5 times upper limit of normal (5 times ULN if liver metastases present)

• Creatinine no greater than 1.5 mg/dL

• Creatinine clearance at least 60 mL/min

• No active infections

• No other serious concurrent systemic disorders that would preclude study participation

• No other malignancy

• No prior hypersensitivity to sulfonamide-based drugs, nonsteroidal anti-inflammatory drugs, or fluorouracil

• No documented dihydropyrimidine dehydrogenase deficiency

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No concurrent immunotherapy

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• No concurrent hormonal therapy

• At least 28 days since prior radiotherapy

• No concurrent radiotherapy

• At least 4 weeks since prior investigational agents

• No other concurrent experimental medications

• No concurrent drugs known to induce cytochrome P450 3A4 (e.g., rifampin, phenytoin, carbamazepine, or barbiturates)