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Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With 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: NCT00254137
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : October 28, 2010
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Sanofi
Pfizer
Hoffmann-La Roche
Information provided by:
Ludwig-Maximilians - University of Munich

Study Description
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Brief Summary:
A randomized phase II-study to evaluate the safety and efficacy of capecitabine plus irinotecan plus cetuximab compared to capecitabine plus oxaliplatin plus cetuximab in first-line treatment of patients with metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: capecitabine Drug: irinotecan Drug: oxaliplatin Drug: cetuximab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II-study to Evaluate the Safety and Efficacy of Capecitabine Plus Irinotecan Plus Cetuximab Compared to Capecitabine Plus Oxaliplatin Plus Cetuximab in First-line Treatment of Patients With Metastatic Colorectal Cancer.
Study Start Date : September 2004
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (CR+PR)

Secondary Outcome Measures :
  1. Time to progression.
  2. Disease control rate (CR+PR+SD).
  3. Safety profile.
  4. Grade 3/4- toxicities.

Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Histologically confirmed metastatic colorectal cancer.
  • EGF-receptor testing.
  • No prior chemotherapy for colorectal cancer (except adjuvant chemotherapy with an interval ³ 6 months).
  • No prior therapy with topoisomerase-1 inhibitors, no prior therapy directed against the EGF-pathway.
  • No prior surgery (except diagnostic biopsy) or radiation therapy 4 weeks before start of study treatment.
  • Measurable disease (diameter ³ 20mm, diameter ³ 10mm with spiral-CT).
  • Male and female patients ³ 18 years, £ 75 years. Karnofsky PS ³ 70%. Life expectancy ³ 3 months. Effective contraception if risk of conception exists.
  • Adequate bone marrow, liver and renal function (leucocytes ³3.000/µl, neutrophils ³1.500/µl, platelets ³100.000/µl, hemoglobin ³9g/dl, bilirubin £1,5x ULN, ASAT and ALAT £3x ULN (£5x ULN with liver metastasis), serum creatinine £1,5x ULN).
  • Written informed consent.

Exclusion Criteria:

  • Concurrent treatment of colorectal cancer (except study medication).
  • EGF-receptor testing not possible.
  • Known DPD-deficiency (no particular screening necessary). Known Gilbert-Meulengracht-Syndrome (no particular screening necessary).
  • Known or expected contraindication against study medication.
  • Participation in other studies during 30 days before study entry.
  • Prior myocardial infarction, severe renal insufficiency (creatinine clearance £30ml/min).
  • Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment and no sign of disease during 5 years).
  • Known or suspected cerebral metastasis.
  • History of inflammatory bowel disease. Symptomatic peritoneal carcinomatosis.
  • Drug or alcohol abuse. Lack of adequate legal capacity.
  • Breast-feeding or pregnant women.
  • Concurrent medication with Sorivudine and analoga, anticoagulation with Cumarine or derivatives.
Contacts and Locations
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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): NCT00254137


Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Merck Sharp & Dohme Corp.
Sanofi
Pfizer
Hoffmann-La Roche
Investigators
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Principal Investigator: Volker Heinemann, PhD, MD University of Munich - Klinikum Grosshadern
More Information
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ClinicalTrials.gov Identifier: NCT00254137    
Other Study ID Numbers: CRC-02-2004
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: October 28, 2010
Last Verified: September 2004
Keywords provided by Ludwig-Maximilians - University of Munich:
capecitabine
irinotecan
cetuximab
oxaliplatin
colorectal 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
Capecitabine
 Oxaliplatin
Irinotecan
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Immunological