Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.
October 27, 2010 updated by: Ludwig-Maximilians - University of Munich
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
92
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Objective response rate (CR+PR)
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Secondary Outcome Measures
Outcome Measure |
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Time to progression.
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Disease control rate (CR+PR+SD).
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Safety profile.
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Grade 3/4- toxicities.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Volker Heinemann, PhD, MD, University of Munich - Klinikum Grosshadern
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Study Completion
November 1, 2006
Study Registration Dates
First Submitted
November 14, 2005
First Submitted That Met QC Criteria
November 14, 2005
First Posted (Estimate)
November 15, 2005
Study Record Updates
Last Update Posted (Estimate)
October 28, 2010
Last Update Submitted That Met QC Criteria
October 27, 2010
Last Verified
September 1, 2004
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Topoisomerase I Inhibitors
- Capecitabine
- Oxaliplatin
- Irinotecan
- Cetuximab
Other Study ID Numbers
- CRC-02-2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.