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Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.

This study has been completed.
Merck Sharp & Dohme Corp.
Hoffmann-La Roche
Information provided by:
Ludwig-Maximilians - University of Munich Identifier:
First received: November 14, 2005
Last updated: October 27, 2010
Last verified: September 2004
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 Intervention Phase
Metastatic Colorectal Cancer
Drug: capecitabine
Drug: irinotecan
Drug: oxaliplatin
Drug: cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Objective response rate (CR+PR)

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

Estimated Enrollment: 92
Study Start Date: September 2004
Estimated Study Completion Date: November 2006

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

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.
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Please refer to this study by its identifier: NCT00254137

Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Merck Sharp & Dohme Corp.
Hoffmann-La Roche
Principal Investigator: Volker Heinemann, PhD, MD University of Munich - Klinikum Grosshadern
  More Information Identifier: NCT00254137     History of Changes
Other Study ID Numbers: CRC-02-2004
Study First Received: November 14, 2005
Last Updated: October 27, 2010

Keywords provided by Ludwig-Maximilians - University of Munich:
colorectal cancer

Additional relevant MeSH terms:
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
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites processed this record on April 28, 2017