Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for advanced colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil combined with leucovorin and either irinotecan or oxaliplatin in treating patients who have unresectable metastatic colorectal cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Research Council
• Treatments: Calcium; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic adenocarcinoma of the colon or rectum

• Unresectable disease

• Measurable or evaluable disease

• No partial or complete bowel obstruction

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 4,000/mm^3

• Platelet count greater than 150,000/mm^3

Hepatic:

• Bilirubin less than 1.25 times upper limit of normal (ULN)

• Alkaline phosphatase less than 5 times ULN

• AST or ALT less than 3 times ULN

• No Gilbert's syndrome or other congenital abnormality of biliary transport (e.g., Crigler-Najjar syndrome or Dubin-Johnson syndrome)

Renal:

• Creatinine clearance greater than 50 mL/min OR

• Glomerular filtration rate normal

Other:

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other uncontrolled medical illness

• No other prior or concurrent malignancy that would preclude study entry

• No chronic diarrhea or inflammatory bowel disease

• No grade 2 or greater pre-existing neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 6 months since prior adjuvant chemotherapy

• Prior adjuvant fluorouracil allowed

• No prior chemotherapy for metastatic disease

• No prior oxaliplatin or irinotecan

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• No prior transplantation surgery requiring immunosuppressive therapy