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Tracking Information | |||||
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First Received Date † | June 16, 2008 | ||||
Last Updated Date | June 16, 2008 | ||||
Start Date † | July 2008 | ||||
Current Primary Outcome Measures † |
To evaluate three-month progression free survival (PFS) rate after therapy with combination of oral topotecan and bevacizumab in subjects with relapsed small-cell lung cancer (SCLC) | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † |
To evaluate objective response rate, PFS, duration of response, time to response, and overall survival. | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Study of Oral Topotecan With Bevacizumab for Recurrent Small Cell Lung Cancer | ||||
Official Title † | An Open-Label, Multicenter, Non-Comparative, Phase II Study of Oral Topotecan in Combination With Bevacizumab for Second-Line Treatment in Subjects With Relapsed Small-Cell Lung Cancer (SCLC) | ||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Recurrent Small-Cell Lung Cancer (SCLC) | ||||
Intervention † | Drug: Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab) | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Not yet recruiting | ||||
Estimated Enrollment † | 50 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00698516 | ||||
Responsible Party | |||||
Secondary IDs †† | 111127 | ||||
Study Sponsor † | GlaxoSmithKline | ||||
Collaborators †† | Genentech | ||||
Investigators † |
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Information Provided By | GlaxoSmithKline | ||||
Verification Date | June 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |