Leucovorin and Fluorouracil With or Without Oxaliplatin Compared to Capecitabine With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, capecitabine, and oxaliplatin, 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 whether leucovorin and fluorouracil with or without oxaliplatin is more effective than capecitabine with or without oxaliplatin in treating patients who have metastatic colorectal cancer.

PURPOSE: This randomized phase III trial is studying four different chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer.

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

Details

• Lead Sponsor: Medical Research Council; University of Leeds
• Collaborators: Medical Research Council; University of Leeds
• Treatments: Calcium; Capecitabine; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of colorectal adenocarcinoma, defined by 1 of the following:

• Prior or current histologically confirmed primary adenocarcinoma of the colon or rectum with clinical/radiological evidence of advanced/metastatic disease

• Histologically or cytologically confirmed metastatic adenocarcinoma with clinical/radiological evidence of colorectal primary tumor

• Unidimensionally measurable disease

• Unfit and unsuitable for full-dose combination chemotherapy, which would include 1 of the following circumstances:

• Unsuitable or unwilling to be entered into any full-dose chemotherapy protocol

• Ineligible or unsuitable for first-line standard combination as per National Institute of Clinical Excellence guidance

PATIENT CHARACTERISTICS:

Age

• Not specified

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC greater than 3,000/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic

• Bilirubin no greater than 3 times upper limit of normal (ULN)

• AST or ALT no greater than 2.5 times ULN

Renal

• Creatinine clearance greater than 50 mL/min OR

• Glomerular filtration rate greater than 30 mL/min

Cardiovascular

• No uncontrolled angina

• No recent myocardial infarction

Other

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

• No partial or complete bowel obstruction

• No concurrent severe uncontrolled medical illness that would preclude study treatment

• No psychiatric or neurological condition that would preclude giving informed consent or complying with oral study medication

• No other prior or concurrent malignant disease that would preclude study treatment or assessment of response

• No prior neuropathy greater than grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 4 months since prior adjuvant chemotherapy with fluorouracil with or without leucovorin calcium

• More than 1 month since prior rectal chemoradiotherapy with fluorouracil with or without leucovorin calcium

• No prior systemic palliative chemotherapy for metastatic disease

Endocrine therapy

• Not specified

Radiotherapy

• See Chemotherapy

Surgery

• Not specified

Other

• No concurrent brivudine or sorivudine