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

NCT00254137 | Completed Phase 2

• 1 other identifier: CRC-02-2004
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Colorectal Cancer

Keywords

capecitabine; irinotecan; cetuximab; oxaliplatin; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (CR+PR)

Secondary Outcomes (4)

• Time to progression.

• Disease control rate (CR+PR+SD).

• Safety profile.

• Grade 3/4- toxicities.

Interventions

capecitabine DRUG

irinotecan DRUG

oxaliplatin DRUG

cetuximab DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Merck Sharp & Dohme LLC: collaborator
• Sanofi: collaborator
• Pfizer: collaborator
• Hoffmann-La Roche: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Irinotecan; Oxaliplatin; Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Volker Heinemann, PhD, MD

  University of Munich - Klinikum Grosshadern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2005
• First Posted: November 15, 2005
• Study Start: September 1, 2004
• Study Completion: November 1, 2006
• Last Updated: October 28, 2010

Record last verified: 2004-09