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

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