Combination Chemotherapy and Cetuximab as First-Line Therapy in Treating Patients With Advanced and/or Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2015-09-01
• 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. 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 giving combination chemotherapy together with intermittent cetuximab is more effective than combination chemotherapy given together with continuous cetuximab in treating colorectal cancer.

PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together with intermittent cetuximab to see how well it works compared to combination chemotherapy given together with continuous cetuximab as first-line therapy in treating patients with advanced or metastatic colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cheryl Pugh
• Treatments: Calcium; Capecitabine; Cetuximab; 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 colon or rectum with clinical or radiological evidence of advanced and/or metastatic disease

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

• Unidimensionally measurable disease by RECIST criteria

• Inoperable metastatic or locoregional disease

• Potentially resectable liver metastases allowed provided the following criteria are met:

• Fewer than 4 unilobar liver metastases, each < 4 cm in size and without major vascular involvement

• No combination chemotherapy allowed prior to the planned resection of operable liver metastases

• No confirmed K-ras mutation of tumor after screening

• No brain metastases

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• Must be considered fit to undergo combination chemotherapy

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Serum bilirubin ≤ 1.25 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 5 times ULN

• AST or ALT ≤ 2.5 times ULN

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

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No severe uncontrolled concurrent medical illness (including poorly controlled angina or myocardial infarction within the past 12 weeks) likely to interfere with protocol treatments

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

• No partial or complete bowel obstruction

• No preexisting neuropathy > grade 1

• No prior or current malignant disease which, in the judgement of the treating investigator, is likely to interfere with COIN-B treatment or assessment of response

• No patients with known hypersensitivity reactions to any of the components of the study treatments

• No proven dihydropyrimidine dehydrogenase deficiency (DPD) or personal or family history of DPD

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior systemic palliative chemotherapy for metastatic disease

• No prior oxaliplatin

• More than 1 month since prior adjuvant chemotherapy comprising fluorouracil (with or without leucovorin calcium), capecitabine, or irinotecan hydrochloride

• More than 1 month since prior chemoradiotherapy comprising fluorouracil (with or without leucovorin calcium) or capecitabine for rectal cancer

• No ongoing requirement for contraindicated concurrent medication

• No concurrent enrollment in any type of study other than observational studies