First-Line Capecitabine and Cetuximab for Metastatic Colorectal Ca in Elderly Patients
Phase 2
Terminated
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00251186
- Brief Summary
This is a Phase II clinical trial measuring the effectiveness of the combination of Capecitabine and cetuximab for first line treatment of colorectal cancer in elderly patients and/or those with multiple comorbidities unable to receive standard chemotherapy. This study will be open approximately 2-3 years. Approximately 36 patients will be enrolled on this study. The study will begin enrolling at The Cancer Institute of New Jersey, with 17 patients in the first group. If more than 4 responses are noted, the accrual will continue to 36 patients throughout CINJOG.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Primary Objective To measure the response (CR/PR) for a novel chemotherapy/biologic combination-capecitabine/cetuximab for patients with metastatic colorectal cancer who are too fragile for more intensive chemotherapy doublet regimens.
- Secondary Outcome Measures
Name Time Method Secondary Objectives To measure progression-free survival and document overall survival in this patient population. To assess the toxicity of capecitabine/cetuximab To describe the baseline quality of life and functional characteristics of elderly patients or those with multiple comorbidities enrolled in this study and assess the impact of disease and its treatment on such functional characteristics.
Trial Locations
- Locations (1)
The Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States