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

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: Hoffmann-La Roche; Merck Sharp & Dohme Corp.; Pfizer; Sanofi
• Treatments: Capecitabine; Cetuximab; Irinotecan; Oxaliplatin

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.