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Trial record 1 of 1 for:    NCT00254137
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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. Identifier: NCT00254137
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : October 28, 2010
Merck Sharp & Dohme Corp.
Hoffmann-La Roche
Information provided by:
Ludwig-Maximilians - University of Munich

Tracking Information
First Submitted Date  ICMJE November 14, 2005
First Posted Date  ICMJE November 15, 2005
Last Update Posted Date October 28, 2010
Study Start Date  ICMJE September 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2005)
Objective response rate (CR+PR)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2005)
  • Time to progression.
  • Disease control rate (CR+PR+SD).
  • Safety profile.
  • Grade 3/4- toxicities.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: capecitabine
  • Drug: irinotecan
  • Drug: oxaliplatin
  • Drug: cetuximab
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 14, 2005)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00254137
Other Study ID Numbers  ICMJE CRC-02-2004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Ludwig-Maximilians - University of Munich
Collaborators  ICMJE
  • Merck Sharp & Dohme Corp.
  • Sanofi
  • Pfizer
  • Hoffmann-La Roche
Investigators  ICMJE
Principal Investigator: Volker Heinemann, PhD, MD University of Munich - Klinikum Grosshadern
PRS Account Ludwig-Maximilians - University of Munich
Verification Date September 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP