Leucovorin and Fluorouracil With or Without Oxaliplatin Compared to Capecitabine With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV rectal cancer, stage IV colon cancer, recurrent rectal cancer, recurrent colon cancer
Eligibility 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
Sites / Locations
- Cookridge Hospital
- Clinical Trials and Research Unit of the University of Leeds
- Medical Research Council Clinical Trials Unit
- Velindre Cancer Center at Velindre Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
MdG (modified de Gramont)
OxMdG (80%) for 12 weeks
Capcitabine
OxCap
2 weekly 5FU/FA schedule
MdG + oxaliplatin