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

Launched by CHERYL PUGH · Mar 19, 2008

Keywords

ClinConnect Summary

OBJECTIVES:

Primary

* To compare the activity, in terms of failure-free survival, of patients with K-ras-normal (wild type) advanced and/or metastatic colorectal cancer treated with intermittent combination chemotherapy comprising oxaliplatin, leucovorin calcium, and fluorouracil (OxMdG) or oxaliplatin and capecitabine (XELOX) and intermittent vs continuous cetuximab as first-line therapy.
* To compare the safety and feasibility of these regimens in these patients.

Secondary

* To compare the safety of cetuximab reintroduction, in terms of frequency of grade 3-4 allergic reactions in the...

Gender

ALL

Eligibility 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