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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00640081
• Date of registration: 19/03/2008
• Primary sponsor: Cheryl Pugh
• Public title: Combination Chemotherapy and Cetuximab as First-Line Therapy in Treating Patients With Advanced and/or Metastatic Colorectal Cancer
• Scientific title: A Two-arm Phase II Randomised Trial of Intermittent Chemotherapy Plus Continuous Cetuximab and of Intermittent Chemotherapy Plus Intermittent Cetuximab in First Line Treatment of Patients With K-ras-normal (Wild-type) Metastatic Colorectal Cancer
• Date of first enrolment: July 2007
• Target sample size: 169
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00640081
• Study type: Interventional
• Study design: Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Cyprus, United Kingdom

Contacts

• Name: Harpreet S. Wasan
• Affiliation: Hammersmith Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Colorectal Cancer

Intervention(s)

Biological: cetuximab

Drug: capecitabine

Drug: fluorouracil

Drug: leucovorin calcium

Drug: oxaliplatin

Other: immunohistochemistry staining method

Other: laboratory biomarker analysis

Primary Outcome(s)

Failure-free survival at 10 months [Time Frame: No]

Secondary Outcome(s)

Overall survival [Time Frame: No]

Progression-free survival [Time Frame: No]

Proportion of patients achieving disease control (complete response plus partial response plus stable disease) at 24 weeks [Time Frame: No]

Response rates at 12, 24, and 36 weeks [Time Frame: No]

Safety of cetuximab reintroduction, in terms of risk of grade 3-4 allergic reactions [Time Frame: Yes]

Toxicity of each treatment regimen by NCI CTCAE v3.0 [Time Frame: Yes]

Secondary ID(s)

CDR0000589635

EU-20828

EUDRACT:2006-003049-17

ISRCTN38375681

MERCK-MRC-CTU-COIN-B/CR11

MRC-CTU-COIN-B/CR11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors