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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00698516 |
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.
Condition | Intervention | Phase |
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Recurrent Small-cell Lung Cancer (SCLC) |
Drug: Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 50 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Open label, Single arm: Experimental
Oral topotecan + IV Bevacizumab
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Drug: Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab)
2.3 mg/m2 daily x 5 oral topotecan and 15 mg/kg IV bevacizumab on day 1 of every 21 days cycle.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 104864/111127 |
Study First Received: | June 16, 2008 |
Last Updated: | July 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00698516 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Small Cell Lung Cancer (SCLC) Topotecan Bevacizumab |
Thoracic Neoplasms Carcinoma, Neuroendocrine Bevacizumab Angiogenesis Inhibitors Recurrence Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Topotecan Adenocarcinoma Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Disease Attributes Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Bevacizumab Pathologic Processes Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Growth Inhibitors |
Angiogenesis Modulating Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Growth Substances Enzyme Inhibitors Angiogenesis Inhibitors Recurrence Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Lung Diseases Adenocarcinoma |