A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer
- Registration Number
- NCT00048126
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will assess the efficacy and safety of continuous oral Xeloda administration in combination with intravenous irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
Inclusion Criteria
- adult patients >=18 years of age;
- locally advanced and/or metastatic colorectal cancer;
- >=1 target lesion.
Exclusion Criteria
- previous treatment with Xeloda or irinotecan;
- previous systemic therapy for metastatic disease;
- progressive disease during previous adjuvant therapy or within 6 months of completion.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 capecitabine [Xeloda] - 1 Irinotecan -
- Primary Outcome Measures
Name Time Method Tumor measurements (RECIST criteria) Event driven
- Secondary Outcome Measures
Name Time Method Time to progression, time to response, duration of response, time to treatment failure, survival.\n Event driven