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Sponsors and Collaborators: |
Hoosier Oncology Group Genentech Walther Cancer Institute |
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Information provided by: | Hoosier Oncology Group |
ClinicalTrials.gov Identifier: | NCT00317200 |
Improvements in therapy for relapsed SCLC are much needed. Paclitaxel has been previously tested and found to have significant single agent activity in relapsed SCLC, including in refractory patients. Angiogenesis plays an important role in SCLC, increased VEGF levels are associated with worse outcomes. Bevacizumab, a monoclonal antibody to VEGF, increase response rates and survival when combined with chemotherapy agents compared with the chemotherapy agent alone in NSCLC, breast cancer, and colorectal cancer. Paclitaxel plus bevacizumab, in the dose and schedule proposed in this study, improves response rates and progression free survival compared with paclitaxel alone in women with metastatic breast cancer. Therefore, we will be testing the safety, feasibility, and efficacy of this regimen in patients with chemosensitive relapsed SCLC.
Condition | Intervention | Phase |
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Small Cell Lung Cancer |
Drug: Paclitaxel Drug: Bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer (SCLC): A Safety, Feasibility and Efficacy Study |
Enrollment: | 34 |
Study Start Date: | April 2006 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Paclitaxel + Devacizumab in patients with chemosensitive relapsed small cell lung cancer.
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Drug: Paclitaxel
Paclitaxel 90 mg/m2 IV infusion over 1 hour, days 1, 8 and 15 of 28 day cycle.
Drug: Bevacizumab
Bevacizumab 10 mg/kg, days 1 and 15 of 28 day cycle
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OUTLINE: This is a multi-center study.
Paclitaxel 90 mg/m2 IV infusion over 1 hour days 1, 8 and 15 of 28 day cycle
Plus
Bevacizumab 10 mg/kg on days 1 and 15 of 28 day cycle.
ECOG Performance Status 0 or 1
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
Highlands Oncology Group | |
Springdale, Arkansas, United States, 72764 | |
United States, Illinois | |
Medical & Surgical Specialists, LLC | |
Galesburg, Illinois, United States, 61401 | |
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202 | |
Cancer Care Center of Southern Indiana | |
Bloomington, Indiana, United States, 47403 | |
Community Regional Cancer Center | |
Indianapolis, Indiana, United States, 46256 | |
Arnett Cancer Care | |
Lafayette, Indiana, United States, 47904 | |
Center for Cancer Care, Inc., P.C. | |
New Albany, Indiana, United States, 47150 | |
Medical Consultants, P.C. | |
Muncie, Indiana, United States, 47303 | |
Fort Wayne Oncology & Hematology, Inc | |
Fort Wayne, Indiana, United States, 46815 | |
Oncology Hematology Associates of SW Indiana | |
Evansville, Indiana, United States, 47714 | |
Center for Cancer Care at Goshen Health System | |
Goshen, Indiana, United States, 46527 | |
Northern Indiana Cancer Research Consortium | |
South Bend, Indiana, United States, 46601 | |
Quality Cancer Center (MCGOP) | |
Indianapolis, Indiana, United States, 46202 | |
United States, Missouri | |
Siteman Cancer Center | |
St. Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
Methodist Cancer Center | |
Omaha, Nebraska, United States, 68114 | |
United States, Pennsylvania | |
Pennsylvania Oncology-Hematology Associates | |
Philadelphia, Pennsylvania, United States, 19106 | |
Fox Chase Cancer Center Extramural Research Program | |
Rockledge, Pennsylvania, United States, 19046 |
Study Chair: | Nasser Hanna, M.D. | Hoosier Oncology Group, LLC |
Responsible Party: | Hoosier Oncology Group ( Nasser Hanna, M.D. ) |
Study ID Numbers: | HOG LUN05-99 |
Study First Received: | April 20, 2006 |
Last Updated: | December 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00317200 |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Carcinoma, Neuroendocrine Bevacizumab Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Respiratory Tract Diseases |
Paclitaxel Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Neoplasms, Nerve Tissue Mitosis Modulators Antimitotic Agents |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |