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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00640081
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Cheryl Pugh, Medical Research Council

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, 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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: cetuximab Drug: capecitabine Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Other: immunohistochemistry staining method Other: laboratory biomarker analysis Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Active Comparator: D
Intermittent chemotherapy plus intermittent cetuximab treatment comprising 12 weeks of chemotherapy plus cetuximab followed by a period off all therapy, with reintroduction of the same chemotherapy and cetuximab regimen for a further 12 weeks after initial progression off treatment
Biological: cetuximab
Drug: capecitabine
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Experimental: E
Intermittent chemotherapy plus continuous cetuximab treatment comprising 12 weeks of chemotherapy plus cetuximab followed by a period of withdrawal of the chemotherapy, but continued weekly cetuximab monotherapy (maintenance cetuximab), with reintroduction of the same chemotherapy regimen to the cetuximab for a further 12 weeks after initial progression off chemotherapy treatment
Biological: cetuximab
Drug: capecitabine
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis



Primary Outcome Measures :
  1. Failure-free survival at 10 months [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. Safety of cetuximab reintroduction, in terms of risk of grade 3-4 allergic reactions [ Time Frame: 12, 24 and 36 weeks ]
  2. Proportion of patients achieving disease control (complete response plus partial response plus stable disease) at 24 weeks [ Time Frame: 24 weeks ]
  3. Overall survival [ Time Frame: at 12, 24 and 36 weeks ]
  4. Progression-free survival [ Time Frame: at 12, 24 and 36 weeks ]
  5. Response rates [ Time Frame: at 12, 24 and 36 weeks ]
  6. Toxicity of each treatment regimen by NCI CTCAE v3.0 [ Time Frame: at 12, 24 and 36 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640081


Locations
Show Show 25 study locations
Sponsors and Collaborators
Cheryl Pugh
Investigators
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Principal Investigator: Harpreet S. Wasan Hammersmith Hospitals NHS Trust
Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

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Responsible Party: Cheryl Pugh, Trial Manager, Medical Research Council
ClinicalTrials.gov Identifier: NCT00640081    
Other Study ID Numbers: CDR0000589635
MRC-CTU-COIN-B/CR11
EUDRACT:2006-003049-17
ISRCTN38375681
EU-20828
MERCK-MRC-CTU-COIN-B/CR11
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication
Keywords provided by Cheryl Pugh, Medical Research Council:
adenocarcinoma of the colon
stage IV colon cancer
adenocarcinoma of the rectum
stage IV rectal cancer
stage III colon cancer
stage III rectal cancer
recurrent colon cancer
recurrent rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Fluorouracil
Capecitabine
Oxaliplatin
Cetuximab
Calcium
Levoleucovorin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins