An Open-label Study of the Effect of Continuous Xeloda Therapy in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
An Open-label Study of the Effect of Continuous Xeloda Therapy in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor measurements (RECIST criteria)
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
MO16460
NCT ID:
NCT00048126
Start Date:
July 2001
Completion Date:
January 2005
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
Name | Location |
|---|---|
| Birmingham, Alabama 35294 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Albany, New York 12208 | |
| Nashville, Tennessee 37203-1632 | |
| Albuquerque, New Mexico 87131-5636 | |
| Boston, Massachusetts | |
| Charlotte, North Carolina | |
| Providence, Rhode Island 02908 |
