Oxaliplatin, Irinotecan, and Capecitabine in Treating Patients With Advanced or Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine when given together with oxaliplatin and irinotecan and to see how well they work in treating patients with advanced or metastatic colorectal cancer that cannot be removed by surgery.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Camptothecin; Capecitabine; Irinotecan; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed unresectable advanced or metastatic colorectal cancer

• Measurable disease (phase II only)

• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI

• No presence or history of CNS metastases

PATIENT CHARACTERISTICS:

Age

• 18 to 70

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.25 times upper limit of normal (ULN) (1.5 times ULN if liver metastases are present)

• AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)

Renal

• Creatinine clearance > 60 mL/min

Cardiovascular

• No New York Heart Association class III-IV congestive heart failure

• No symptomatic coronary artery disease

• No uncontrolled cardiac arrhythmia

• No myocardial infarction within the past year

• No other clinically significant cardiac disease

Immunologic

• No active autoimmune disease

• No uncontrolled infection

• No prior severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil

• No known hypersensitivity to any component of study drugs

Other

• Not pregnant or nursing

• Negative pregnancy test

• Patients must use effective contraception during and for 1 year after study participation

• No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer

• No peripheral neuropathy > grade 1 of any origin (e.g., alcohol or diabetes)

• No nausea, vomiting, or malabsorption syndrome that would preclude ingestion or absorption of oral medication

• No psychiatric disability that would preclude study compliance

• No uncontrolled diabetes

• No other serious underlying medical condition that would preclude study participation

• No known dihydropyrimidine dehydrogenase deficiency

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent prophylactic hematopoietic growth factors

Chemotherapy

• More than 6 months since prior adjuvant fluoropyrimidine chemotherapy

• No other prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No concurrent radiotherapy

• Concurrent radiotherapy of a single painful lesion allowed

Surgery

• Not specified

Other

• More than 30 days since prior clinical trial participation

• No other concurrent experimental drugs

• No other concurrent anticancer therapy

• No concurrent sorivudine or its chemically-related analogues (e.g., lamivudine)