Phase II Study of First-Line Capecitabine and Cetuximab for Treatment of Metastatic Colorectal Cancer in Elderly Patients and/or Those With Multiple Comorbidities Unable to Receive Chemotherapy Doublets
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- University of Medicine and Dentistry of New Jersey
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Primary Objective
- Status
- Terminated
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- 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.