Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.
NCT00254137
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer. | |||
| Official Title ICMJE | 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. | |||
| 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 Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Metastatic Colorectal Cancer | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 92 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | November 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00254137 | |||
| Other Study ID Numbers ICMJE | CRC-02-2004 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Ludwig-Maximilians - University of Munich | |||
| Collaborators ICMJE |
| |||
| Investigators ICMJE |
| |||
| PRS Account | Ludwig-Maximilians - University of Munich | |||
| Verification Date | September 2004 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||