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Cetuximab, Capecitabine, Oxaliplatin and Bevacizumab in Advanced 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: NCT00208546
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : February 2, 2012
Koningin Wilhelmina Fonds
Roche Pharma AG
Information provided by (Responsible Party):
Dutch Colorectal Cancer Group

Brief Summary:

This is a study to assess the efficacy and safety of the addition of cetuximab to the combined regimen of capecitabine, oxaliplatin and bevacizumab in patients with previously untreated advanced colorectal carcinoma. It is an open, comparative study, comparing the effects of capecitabine, oxaliplatin and bevacizumab to those of the same regimen plus cetuximab.

Seven hundred fifty patients will be included. Treatment will continue until disease progression or serious toxicity and follow up will continue until death. It is anticipated that the addition of cetuximab will lead to an increase in progression free survival.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: 21Capecitabine + bevacizumab + oxaliplatin Drug: 1Capecitabine + oxaliplatin + bevacizumab + cetuximab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cetuximab Added to Capecitabine, Oxaliplatin and Bevacizumab in Patients With Previously Untreated Advanced Colorectal Carcinoma, a Randomised Phase III Study
Study Start Date : June 2005
Actual Primary Completion Date : July 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1Capecitabine + bevacizumab + oxaliplatin + cetuximab Drug: 1Capecitabine + oxaliplatin + bevacizumab + cetuximab
3-weekly cycles: Ca 1000 mg/m2 orally day 1-14, O 130 mg/m2 i.v. day 1 (6 cycles), B 7,5 mg/kg i.v. day 1, Ce 250 mg/m2 i.v. day 1, 8, 15 (day 1 cycle 1: 400 mg/m2).

Active Comparator: 21Capecitabine + bevacizumab + oxaliplatin Drug: 21Capecitabine + bevacizumab + oxaliplatin
3-weekly cycles: Ca 1000 mg/m2 orally day 1-14, O 130 mg/m2 i.v. day 1 (6 cycles), B 7,5 mg/kg i.v. day 1.

Primary Outcome Measures :
  1. progression free survival [ Time Frame: study duration ]
  2. toxicity [ Time Frame: study duration ]

Secondary Outcome Measures :
  1. tumour response (complete response [CR], partial response [PR] or stable disease [SD]) [ Time Frame: study duration ]
  2. response duration [ Time Frame: study duration ]
  3. overall survival [ Time Frame: study duration ]
  4. quality of life [ Time Frame: study duration ]
  5. translational research [ Time Frame: study duration ]

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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Histology and Staging Disease

  • Histologically proven advanced colorectal cancer (CRC); not amenable to curative surgery
  • Of Note: In case of a single metastasis, histological or cytological proof of colorectal carcinoma should be obtained prior to randomisation.
  • Unidimensionally measurable disease (>= 1 cm on spiral CT scan or >= 2 cm on chest X-ray; liver ultrasound not allowed). Index lesions should not be in a previously irradiated area. Serum carcinoembryonic antigen (CEA) may not be used as a parameter for disease evaluation.
  • In case of previous radiotherapy, at least one measurable lesion should be located outside the irradiated field.

General Conditions

  • Signed written informed consent
  • Age 18 years and above
  • World Health Organization (WHO) performance status 0-1
  • Adequate bone marrow function (white blood cell count [WBC] > 3.0 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin [Hb] > 6 mmol/L)
  • Adequate hepatic function: total bilirubin < 2 x upper normal limit, aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) < 3 x upper normal limits (in case of liver metastases < 5 x upper normal limits)
  • Adequate renal function: serum creatinine < 1.5 x upper normal limit
  • Urinary protein excretion < 0.5 gram/24h
  • Expected adequacy of follow-up

Exclusion Criteria:

  • Prior chemotherapy for advanced disease; prior adjuvant chemotherapy is allowed provided that the last administration was given > 6 months prior to randomisation, and that patients have recovered from all toxic events related to adjuvant chemotherapy, and that safety evaluations during adjuvant chemotherapy do not present any risk for serious adverse events during the administration of protocol treatment.
  • Previous radiotherapy for rectal cancer or for symptomatic treatment of distant metastases is allowed, provided that at least one measurable lesion is located outside the irradiated field, irradiation has been completed for at least 4 weeks, and patients have recovered from all side effects.
  • Previous epidermal growth factor receptor (EGFR) targeting therapy
  • Sensory neuropathy > grade 1
  • Bleeding diathesis or coagulation disorders or the need for full-dose anticoagulation
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the start of drug administration
  • Anticipated major surgical procedure during the course of the study
  • Serious non-healing wound or ulcer
  • Any condition preventing the intake or absorption of oral drugs
  • Significant cardiovascular disease (unstable angina pectoris, recent myocardial infarction < 12 months, uncontrolled hypertension, previous cerebrovascular disease)
  • Pregnancy or lactation
  • Patients (males/females) with reproductive potential not implementing adequate contraceptive measures
  • Central nervous system metastases (in asymptomatic patients no screening is required)
  • Serious active infections
  • Other serious concomitant diseases preventing the safe administration of study drugs or likely to interfere with the study assessments
  • Other malignancies in the past 5 years with the exception of adequately treated carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin
  • Concomitant treatments: concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation; concurrent treatment with any other anti-cancer therapy; full-dose anticoagulation
  • Continuous use of immunosuppressive agents

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): NCT00208546

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University Medical Center Nijmegen
Nijmegen, Gelderland, Netherlands
Sponsors and Collaborators
Dutch Colorectal Cancer Group
Koningin Wilhelmina Fonds
Roche Pharma AG
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Principal Investigator: C JA Punt, MD PhD University Medical Centre Nijmegen

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dutch Colorectal Cancer Group Identifier: NCT00208546    
Other Study ID Numbers: CAIRO2
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: February 2012
Keywords provided by Dutch Colorectal Cancer Group:
advanced 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
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action