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

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Sanofi
Pfizer
Hoffmann-La Roche
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00254137
First received: November 14, 2005
Last updated: October 27, 2010
Last verified: September 2004
  Purpose

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
Endpoint Classification: Efficacy Study
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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254137

Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Merck Sharp & Dohme Corp.
Sanofi
Pfizer
Hoffmann-La Roche
Investigators
Principal Investigator: Volker Heinemann, PhD, MD University of Munich - Klinikum Grosshadern
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00254137     History of Changes
Other Study ID Numbers: CRC-02-2004
Study First Received: November 14, 2005
Last Updated: October 27, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
capecitabine
irinotecan
cetuximab
oxaliplatin
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Irinotecan
Capecitabine
Cetuximab
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014