Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating older patients with metastatic colorectal cancer.

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

Details

• Lead Sponsor: UNICANCER
• Treatments: Capecitabine; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of colorectal adenocarcinoma

• Metastatic disease

• Requires first-line therapy for metastatic disease

PATIENT CHARACTERISTICS:

Age

• Over 70

Performance status

• Katz's Activities of Daily Living scale < 6 (≤ 6 for patients ≥ 80 years of age)

Life expectancy

• More than 3 months

Hematopoietic

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

• Platelet count > 100,000/mm^3

Hepatic

• AST and ALT < 2 times normal (5 times normal if due to hepatic metastases)

• Bilirubin < 2 times normal (5 times normal if due to hepatic metastases)

Renal

• Creatinine clearance > 30 mL/min

Other

• No clinical neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 6 months since prior adjuvant chemotherapy

• No prior chemotherapy for metastatic disease

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified