Study of Oral Topotecan With Bevacizumab for Recurrent Small Cell Lung Cancer
Part of paid clinical trials in Jonesboro, Arkansas.
- Sponsor
- GlaxoSmithKline
- Study ID
- NCT00698516
- Phase
- PHASE2
- Status
- Completed
Conditions
- Lung Cancer, Small Cell
- Recurrent Small-cell Lung Cancer (SCLC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab) — DRUG2.3 mg/m2 daily x 5 oral topotecan and 15 mg/kg IV bevacizumab on day 1 of every 21 days cycle.
Study Details
Combination of Hycamtin (topotecan) and Avastin (bevacizumab) could allow killing of both endothelial and neoplastic cells. We postulate that addition of bevacizumab to topotecan will increase delivery of topotecan to tumor cells and may enhance activity of topotecan in patients with previously treated small cell lung cancer and improve progression free survival.
Key Dates
- First listed
- Jun 17, 2008
- Start date
- Jul 31, 2008
- Status verified
- Mar 2011
- Primary completion
- May 31, 2010
- Completion
- May 31, 2010
Study Design
- Enrollment
- 50 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Open label, Single armOral topotecan + IV Bevacizumab
Primary Outcome Measure
Percentage of Participants With Progression-free Survival (PFS) at 3 Months [ Time Frame: 3 months ]
Locations (16)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | - |
| GSK Investigational Site | Gainesville | Florida | 32605 | - |
| GSK Investigational Site | Naples | Florida | 34119 | - |
| GSK Investigational Site | Athens | Georgia | 30607 | - |
| GSK Investigational Site | Macon | Georgia | 31201 | - |
| GSK Investigational Site | Marietta | Georgia | 30060 | - |
| GSK Investigational Site | Jackson | Mississippi | 39202 | - |
| GSK Investigational Site | Cincinnati | Ohio | 45236 | - |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | - |
| GSK Investigational Site | Chattanooga | Tennessee | 37404 | - |
| GSK Investigational Site | Memphis | Tennessee | 38104 | - |
| GSK Investigational Site | Memphis | Tennessee | 38120 | - |
| GSK Investigational Site | Nashville | Tennessee | 37203 | - |
| GSK Investigational Site | Fort Worth | Texas | 76104 | - |
| GSK Investigational Site | Seattle | Washington | 98101-2795 | - |
| GSK Investigational Site | Madison | Wisconsin | 53792 | - |
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