Status:
COMPLETED
Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Sanofi
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00254137
Start Date
September 1 2004
End Date
November 1 2006
Last Update
October 28 2010
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