Combination Chemotherapy With or Without Cetuximab Before and After Surgery in Treating Patients With Resectable Liver Metastases Caused By Colorectal Cancer

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

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without cetuximab in treating liver metastases caused by colorectal cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without cetuximab before and after surgery in treating patients with resectable liver metastases caused by colorectal cancer.

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

Details

• Lead Sponsor: University of Southampton
• Collaborator: University Hospital Southampton NHS Foundation Trust
• Treatments: Calcium; Capecitabine; Cetuximab; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically* or radiologically confirmed primary adenocarcinoma of the colon or rectum

• Advanced and/or metastatic disease NOTE: *Liver metastases should not be biopsied

• Must have potentially resectable liver metastases present, as defined by any of the following:

• Metachronous metastases AND complete resection of the primary tumor without gross or microscopic evidence of residual disease (R0)

• Synchronous metastases AND R0 resection of the primary tumor > 1 month before study entry

• Synchronous metastases with sufficient evidence (e.g., by CT scan or diagnostic laparoscopy) that both the primary tumor and the liver metastases can be completely resected during the same procedure and resection of primary tumor can be delayed for 3-4 months

• Suboptimally resectable disease (i.e., potentially resectable disease with compromise of the resection margins)

• No detectable extrahepatic tumor that cannot be completely resected

• Unidimensionally measurable disease

• No brain metastases

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• WBC ≥ 4,000/mm³

• ANC ≥ 1,500/mm³

• Platelet count > 150,000/mm³

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

• Alkaline phosphatase ≤ 5 times ULN

• AST or ALT ≤ 3 times ULN

• Creatinine clearance > 50 mL/min OR glomerular filtration rate > 50 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment

• No psychiatric or neurological condition that would preclude study compliance

• No partial or complete bowel obstruction

• No preexisting neuropathy > grade 1

• No other prior or concurrent malignant disease that, in the opinion of the investigator, would preclude study treatment

• No concurrent severe uncontrolled medical illness (including poorly-controlled angina or myocardial infarction within the past 3 months) that would preclude study treatment

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

PRIOR CONCURRENT THERAPY:

• No prior systemic chemotherapy for metastatic disease

• More than 6 months since prior adjuvant chemotherapy comprising fluorouracil, leucovorin calcium, capecitabine, or irinotecan hydrochloride

• More than 1 month since prior rectal chemoradiotherapy comprising fluorouracil and leucovorin calcium

• No concurrent contraindicated medication