Metastatic Colorectal Cancer
Conditions
Keywords
capecitabine, irinotecan, cetuximab, oxaliplatin, colorectal cancer
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.
Interventions
DRUGcapecitabine
DRUGirinotecan
DRUGoxaliplatin
DRUGcetuximab
Sponsors
Merck Sharp & Dohme LLC
Sanofi
Pfizer
Hoffmann-La Roche
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (CR+PR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression. | — |
| Disease control rate (CR+PR+SD). | — |
| Safety profile. | — |
| Grade 3/4- toxicities. | — |
Outcome results
None listed