Irinotecan With or Without Capecitabine as Second-Line Therapy in Treating Older Patients With Progressive, Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

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

Summary

RATIONALE: Drugs used in chemotherapy, such as 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. It is not yet known whether irinotecan and capecitabine are more effective than irinotecan alone in treating colorectal cancer.

PURPOSE: This randomized phase II trial is studying irinotecan and capecitabine to see how well they work as second-line therapy compared to irinotecan alone in treating older patients with progressive, metastatic colorectal cancer that cannot be removed by surgery.

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

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Treatments: Camptothecin; Capecitabine; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic adenocarcinoma of the colon or rectum

• Unresectable disease

• Documented progressive disease during first-line/palliative chemotherapy

• Measurable disease ≥ 1 cm that is outside prior radiation field

• No brain metastases

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• Life expectancy ≥ 3 months

• No contraindication to chemotherapy

• Creatinine clearance ≥ 40 mL/min

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

• Platelet count ≥ 100,000/mm^3

• Alkaline phosphatase ≤ 3 times normal (5 times normal if hepatic involvement)

• Bilirubin ≤ 1.5 times normal

• Transaminases ≤ 5 times normal

• No symptomatic coronary disease or cardiac insufficiency

• No enteropathy or chronic diarrhea

• No unresolved intestinal occlusion or subocclusion

• No history of severe unexpected reaction to a fluoropyrimidine

• No other active malignancy in the past 2 years

• No hypersensitivity to irinotecan hydrochloride or its excipients

• No hypersensitivity to capecitabine or fluorouracil

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior extensive resection

• No concurrent sorivudine or similar analogs (e.g., brivudine)

• No other concurrent anticancer therapy

• Concurrent radiotherapy allowed for nontarget lesions