Combination Chemotherapy With or Without Cetuximab as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

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

Summary

RATIONALE: Drugs used in chemotherapy 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. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy and cetuximab are more effective than combination chemotherapy alone in treating colorectal cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone as first-line therapy in treating patients with metastatic colorectal cancer.

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

Details

• Lead Sponsor: Velindre NHS Trust
• Treatments: Calcium; Capecitabine; Cetuximab; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

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

• Histologically confirmed primary adenocarcinoma of the colon or rectum with clinical or radiological evidence of advanced and/or metastatic disease

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

• Unidimensionally measurable disease

• Inoperable metastatic or locoregional disease

• Ineligible for hepatic resection after first-line combination chemotherapy

• No brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

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

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.25 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 5 times ULN

• AST or ALT ≤ 2.5 times ULN

Renal

• Creatinine clearance or glomerular filtration rate ≥ 50 mL/min

Cardiovascular

• No poorly controlled angina

• No myocardial infarction within the past 3 months

Other

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

• Must be considered fit to undergo combination chemotherapy

• No psychiatric or neurological condition that would preclude study compliance or giving informed consent

• No partial or complete bowel obstruction

• No other malignant disease that would preclude study treatment

• No preexisting neuropathy > grade 1

• No known hypersensitivity reaction to any of the components of study drugs

• No known DPD deficiency or personal or family history suggestiv of DPD deficiency

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior systemic palliative chemotherapy for metastatic disease

• No prior oxaliplatin

• More than 1 month since prior adjuvant fluorouracil (5-FU) (with or without leucovorin calcium), capecitabine, or irinotecan

• More than 1 month since prior rectal chemoradiotherapy with 5-FU (with or without leucovorin calcium) or capecitabine

Endocrine therapy

• Not specified

Radiotherapy

• See Chemotherapy

Surgery

• Not specified

Other

• No concurrent brivudine or sorivudine (for patients receiving capecitabine on study)