Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.
Keywords
Abstract
Dates
| Last Verified: | 08/31/2004 |
| First Submitted: | 11/13/2005 |
| Estimated Enrollment Submitted: | 11/13/2005 |
| First Posted: | 11/14/2005 |
| Last Update Submitted: | 10/26/2010 |
| Last Update Posted: | 10/27/2010 |
| Actual Study Start Date: | 08/31/2004 |
| Estimated Study Completion Date: | 10/31/2006 |
Condition or disease
Intervention/treatment
Drug: capecitabine
Drug: irinotecan
Drug: oxaliplatin
Drug: cetuximab
Phase
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
Primary Outcome Measures
1. Objective response rate (CR+PR) [undefined]
Secondary Outcome Measures
1. Time to progression. [undefined]
2. Disease control rate (CR+PR+SD). [undefined]
3. Safety profile. [undefined]
4. Grade 3/4- toxicities. [undefined]
