A Randomized, Open-label Study of the Effect of Intermittent Xeloda Versus iv Fluorouracil/Leucovorin, Both in Combination With Eloxatin, on Tumor Progression in Patients With Metastatic Colorectal Cancer Who Received Prior CPT-11 and 5-fluorouracil/Leucovorin
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
A Randomized, Open-label Study of the Effect of Intermittent Xeloda Versus iv Fluorouracil/Leucovorin, Both in Combination With Eloxatin, on Tumor Progression in Patients With Metastatic Colorectal Cancer Who Received Prior CPT-11 and 5-fluorouracil/Leucovorin
Inclusion Criteria:
- adult patients >=18 years of age;
- metastatic colorectal cancer;
- >=1 target lesion;
- failed first-line chemotherapy with 5-fluorouracil and irinotecan.
Exclusion Criteria:
- previous treatment with oxaliplatin;
- progressive or recurrent disease during or within 6 months of completion of
first-line chemotherapy;
- >=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic
disease.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to tumor progression
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:
NO16967
NCT ID:
NCT00069108
Start Date:
May 2003
Completion Date:
January 2008
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
Name | Location |
|---|---|
| Bettendorf, Iowa 52722 | |
| Great Falls, Montana 59405 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Omaha, Nebraska 68114 | |
| Hackensack, New Jersey 07601 | |
| Albuquerque, New Mexico 87131-5636 | |
| Denver, Colorado | |
| Milwaukee, Wisconsin | |
| Indianapolis, Indiana | |
| Washington, District of Columbia | |
| Salt Lake City, Utah 84112 |
