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Status:

COMPLETED

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

Lead Sponsor:

Cheryl Pugh

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18-100 years

Phase:

PHASE2

Brief 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,...

Detailed Description

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 com...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2015

    Estimated Enrollment :

    169 Patients enrolled

    Trial Details

    Trial ID

    NCT00640081

    Start Date

    July 1 2007

    End Date

    September 1 2015

    Last Update

    September 22 2021

    Active Locations (25)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 7 (25 locations)

    1

    Bank of Cyprus Oncology Centre

    Nicosia, Cyprus

    2

    Bradford Royal Infirmary

    Bradford, England, United Kingdom, BD9 6RJ

    3

    Gloucestershire Oncology Centre at Cheltenham General Hospital

    Cheltenham, England, United Kingdom, GL53 7AN

    4

    Essex County Hospital

    Colchester, England, United Kingdom, C03 3NB