Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors

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

Summary

Drugs used in chemotherapy, such as irinotecan, oxaliplatin, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. This phase I trial is studying the side effects and best dose of irinotecan, oxaliplatin, and capecitabine in treating patients with unresectable solid tumors.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Camptothecin; Capecitabine; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically confirmed solid tumor for which there is no known standard therapy that is potentially curative or capable of extending life expectancy

• Unresectable disease

• Willing to provide biologic specimens to determine UGT1A1 genotype

• No CNS metastases

• Prior CNS metastases allowed provided patient was treated with surgery and/or radiotherapy and is stable for more than 8 weeks

• Performance status - ECOG 0-2

• At least 12 weeks

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

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

• Hemoglobin at least 9.0 g/dL

• Bilirubin no greater than upper limit of normal (ULN) for patients with 6/6 UGT1A1 genotype (1.5 times ULN for patients with 6/7 [closed to accrual as of 8/24/06] or 7/7 UGT1A1 genotype)

• AST no greater than 3 times ULN (5 times ULN if there is liver involvement)

• Creatinine no greater than 1.5 times ULN

• No New York Heart Association class III or IV heart disease

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No prior allergy to platinum compounds, irinotecan, or to antiemetics or antidiarrheals appropriate for administration with study therapy

• No uncontrolled infection

• No seizure disorder

• No peripheral neuropathy grade 2 or greater

• More than 4 weeks since prior biologic therapy

• More than 4 weeks since prior immunotherapy

• No concurrent immunotherapy

• No concurrent prophylactic colony-stimulating factor therapy

• More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered

• No other concurrent chemotherapy

• See Disease Characteristics

• More than 4 weeks since prior radiotherapy

• No prior radiotherapy to more than 25% of the bone marrow

• No concurrent radiotherapy

• See Disease Characteristics

• No other concurrent investigational therapy

• No concurrent sorivudine, brivudine, lamivudine, or stavudine

• No concurrent enrollment in any other study involving a pharmacologic agent for symptom control or therapeutic intent