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Sponsors and Collaborators: |
Sarah Cannon Research Institute SCRI Oncology Research Consortium Genentech Sanofi-Aventis |
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Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00621049 |
Multicenter randomized phase II trial is to examine the safety and efficacy of carboplatin, docetaxel, bevacizumab followed by maintenance bevacizumab and erlotinib in patients with completely resected stage IB, II, and select III NSCLC.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: Docetaxel, Carboplatin, Bevacizumab, Erlotinib Drug: Docetaxel, Carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase II Trial of Adjuvant Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Patients With Resected Non-Small Cell Lung Cancer |
Estimated Enrollment: | 172 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Docetaxel, Carboplatin, Bevacizumab and Erlotinib
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Drug: Docetaxel, Carboplatin, Bevacizumab, Erlotinib
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1 Docetaxel should be administered before carboplatin. After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows: Maintenance Treatment for patients in Cohort A: Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity. |
B: Active Comparator
Docetaxel, Carboplatin
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Drug: Docetaxel, Carboplatin
Adjuvant Treatment Cohort B: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Docetaxel should be administered before carboplatin. Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with completely resected (R0) stage IB, II, and select III NSCLC. The following stages are eligible:
IB T2 N0 IIA T1 N1 IIB T2 N1 IIB T3 N0 IIIA T3 N1
Exclusion Criteria:
Patients with proteinuria at screening as demonstrated by either:
Contact: David Spigel, M.D. | (615) 329-7274 | dspigel@tnonc.com |
Contact: Trials Info | (615) 329-7274 | trialsinfo@scresearch.net |
United States, Alabama | |
Northeast Alabama Regional Medical Center | Recruiting |
Anniston, Alabama, United States, 36207 | |
United States, Florida | |
Florida Cancer Specialists | Recruiting |
Fort Myers, Florida, United States, 33901 | |
Contact: Katie Goodman 239-274-9930 KatieG@flcancer.com | |
United States, Georgia | |
Wellstar Cancer Research | Recruiting |
Marietta, Georgia, United States, 30060 | |
United States, Kentucky | |
Consultants in Blood Disorders and Cancer | Recruiting |
Louisville, Kentucky, United States, 40207 | |
Contact: Judy Sisk 502-897-1166 ext 129 jsisk@cbcdocs.com | |
United States, Louisiana | |
Hematology Oncology Life Center | Recruiting |
Alexandria, Louisiana, United States, 71301 | |
Baton Rouge General Medical Center | Recruiting |
Baton Rouge, Louisiana, United States, 70806 | |
United States, Mississippi | |
Jackson Oncology Associates | Recruiting |
Jackson, Mississippi, United States, 39202 | |
United States, Missouri | |
St. Louis Cancer Care | Recruiting |
Chesterfield, Missouri, United States, 63017 | |
United States, Nebraska | |
Methodist Cancer Center | Recruiting |
Omaha, Nebraska, United States, 68114 | |
United States, New Jersey | |
Hematology Oncology Associates of Northern NJ | Recruiting |
Morristown, New Jersey, United States, 07960 | |
United States, New Mexico | |
New Mexico Oncology Hematology Consultants | Recruiting |
Albuquerque, New Mexico, United States, 87109 | |
United States, North Carolina | |
Cancer Care of Western North Carolina | Recruiting |
Asheville, North Carolina, United States, 28801 | |
United States, Ohio | |
Oncology Hematology Care | Recruiting |
Cincinnati, Ohio, United States, 45242 | |
Contact: Research Program Coordinator 513-891-4800 contact@ohcmail.com | |
United States, Tennessee | |
Tennessee Oncology, PLLC | Recruiting |
Nashville, Tennessee, United States, 37023 | |
Chattanooga Oncology Hematology Associates | Recruiting |
Chattanooga, Tennessee, United States, 37404 | |
Contact: Research Coordiantor 423-698-1844 research@cohaonline.com | |
Associates in Hematology Oncology | Recruiting |
Chattanooga, Tennessee, United States, 37404 | |
United States, Virginia | |
Peninsula Cancer Institute | Recruiting |
Newport News, Virginia, United States, 23601 |
Study Chair: | David Spigel, M.D. | SCRI Oncology Research Consortium |
Responsible Party: | SCRI Oncology Research Consortium ( David Spigel, M.D. ) |
Study ID Numbers: | SCRI LUN 142, US_IST_12218, AVF3923s |
Study First Received: | December 26, 2007 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00621049 |
Health Authority: | United States: Institutional Review Board |
Non-Small Cell Lung Cancer Resected Carboplatin |
Docetaxel Bevacizumab Erlotinib |
Erlotinib Docetaxel Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carboplatin Bevacizumab Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |