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Safety and Efficacy Study of Combination Therapy With Cetuximab and FOLFOX4 in Patients With 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. Identifier: NCT00202787
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 20, 2013
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Brief Summary:
The purpose of this study is to determine confirmed objective response rate to combination therapy with cetuximab and FOLFOX4 or FOLFOX4 alone in patients with CRC and non-resectable hepatic metastases

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: FOLFOX-4+cetuximab Drug: FOLFOX-4 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Phase II, Randomised, Pilot Study to Evaluate the Safety and Efficacy of Combination Therapy With Cetuximab and FOLFOX4 or FOLFOX4 Alone in Patients Colorectal Cancer and Initially Non-resectable
Study Start Date : February 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: 1
Drug: FOLFOX-4+cetuximab

Cetuximab; Weekly administration of Cetuximab IV (initial infusion of 400 mg/m2 for 120 minutes followed by subsequent maintenance doses of 250 mg/m2 for 60 minutes);

FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2

Active Comparator: 2
Drug: FOLFOX-4
FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2

Primary Outcome Measures :
  1. Determine confirmed objective response rate [ Time Frame: 2005-2009 ]

Secondary Outcome Measures :
  1. Determine safety of combination, surgical resectability and R0 resections, clinical benefit, time to disease progression, time to onset of response, duration of response, time to treatment failure, overall survival time [ Time Frame: 2005-2009 ]
  2. determination of polymorphisms of the intron 1 of the EGFR gene, TS, XRCC1, XPD, serum levels of EGFR and ATP7A and ATP7B, nº of copies of EGFR gene, the levels of PTEN, EGFR, AKT y MAPK proteins, and mutations at EGFR, PI3KCA, K-RAS y B-RAF genes [ Time Frame: 2005-2009 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent.
  • Men and women < 75 years
  • Histologically confirmed diagnosis of CRC
  • Metastatic colorectal carcinoma with exclusive non-resectable hepatic metastases, due to fulfillment of one of the following criteria:

    1. Number of hepatic metastases > or= 4;
    2. Size of one or more hepatic metastases > 5 cm diameter;
    3. Vascular involvement and/or poor site that prevent complete resection of hepatic disease and/or require resection with the remaining liver mass less than 25-30% of functional liver.
  • Presence of at least one lesion detectable by two-dimensional measurement.
  • Karnofsky functional status >or=70% at the time of enrollment in study
  • Life expectancy greater than 3 months.
  • Patients must not have received chemotherapy for advanced/metastatic disease.
  • Patients with the following characteristics will be enrolled:

    1. Recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with disease-free period > 6 months following conclusion of treatment.
    2. Recurrence after surgical and/or radiotherapy treatment without adjuvant systemic treatment.
    3. De novo diagnosis of disease.
  • Proper liver function, defined by aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) < or = 2.5 x ULN (< or = 5 x ULN if there are hepatic metastases) and total bilirubin count < 1.5 x ULN.
  • Proper kidney function, defined as serum creatinine < 1.5 x ULN.
  • Proper hematological function, defined as neutrophil count > or = 1.5 x 109/l , platelets > or = 100 X 109/l and hemoglobin > or = 9 g/dl.
  • Effective birth control method for men as well as women if there is possibility of pregnancy

Exclusion Criteria:

  • Documented or suspected cerebral and/or leptomeningeal metastases.
  • Metastasis in any other non-hepatic site, including extrahepatic lymph node metastases.
  • Surgery (excluding biopsy for diagnosis) and/or radiotherapy within 4 weeks prior to enrollment in the study.
  • Participation in another clinical trial with medication in the past 30 days.
  • Chronic, concomitant administration of systemic immunotherapy, chemotherapy, hormone therapy or any other investigational drug.
  • Prior malignant tumour in past 5 years, except history of basal cell skin carcinoma or pre-invasive cervical carcinoma.
  • Any investigational drug during the 4 weeks prior to enrolment.
  • Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment.
  • Prior participation in study in which treatment with cetuximab can be assigned (whether or not treatment with cetuximab is received)
  • Acute or subacute intestinal occlusion or history of inflammatory intestinal disease.
  • Evidence of grade 3 or 4 allergic reaction to any of the treatment components.
  • Clinically relevant peripheral neuropathy.
  • Clinically relevant myocardial disease or history of myocardial infarction in the past 12 months.
  • Known abuse of alcohol / drugs, Legal incapacity or limited legal capacity.
  • Any medical or psychological disorder which, in the opinion of the investigator, does not allow the patient to conclude the study or sign the informed consent.
  • Pregnant or nursing woman

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 identifier (NCT number): NCT00202787

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Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)
Madrid, Spain, 28046
Sponsors and Collaborators
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Merck Sharp & Dohme Corp.
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Study Chair: Albert Abad Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)
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Responsible Party: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) Identifier: NCT00202787    
Other Study ID Numbers: TTD-04-02
eudract-number: 2004-001700-12
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013
Keywords provided by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD):
colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Growth Substances