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

Phase 2

Completed

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT00254137
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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 available

Study Timeline

• Status Verified: 2004-09
• Study Start: 2004-09
• Study First Submitted: 2005-11-14
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-15
• Study Completion: 2006-11
• Last Update Submitted: 2010-10-27
• Last Update Posted: 2010-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Objective response rate (CR+PR)

Secondary Outcome Measures

Name	Time	Method
Time to progression.
Disease control rate (CR+PR+SD).
Safety profile.
Grade 3/4- toxicities.