A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT00048139
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Irinotecan — DRUG250mg/m2 iv on day 1 of each 3 week cycle
- capecitabine [Xeloda] — DRUG1000mg/m2 po bid on days 1-15 of each 3 week cycle
Study Details
This study will assess the efficacy and safety of intermittent oral Xeloda administration in combination with 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.
Key Dates
- Start date
- Oct 31, 2001
- Status verified
- Nov 2016
- Primary completion
- Jun 30, 2005
- Completion
- Jun 30, 2005
Study Design
- Enrollment
- 52 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1
Primary Outcome Measure
Tumor measurement (RECIST criteria) [ Time Frame: Event driven ]
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Phoenix | Arizona | 85012 | - |
| - | Fountain Valley | California | 92708 | - |
| - | La Jolla | California | 92037-1030 | - |
| - | Santa Rosa | California | 95403 | - |
| - | Denver | Colorado | 80262 | - |
| - | Hutchinson | Kansas | 67502 | - |
| - | Las Vegas | Nevada | 89109 | - |
| - | Albuquerque | New Mexico | 87102 | - |
| - | Albuquerque | New Mexico | 87131-5636 | - |
| - | Buffalo | New York | 14263 | - |
| - | Houston | Texas | 77030 | - |
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