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Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00280150 |
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Radiation therapy uses high energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with bevacizumab, radiation therapy, and erlotinib may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of bevacizumab and erlotinib when given together with combination chemotherapy and radiation therapy and to see how well they work in treating patients with stage III non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: bevacizumab Drug: carboplatin Drug: erlotinib hydrochloride Drug: paclitaxel Procedure: 3-dimensional conformal radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control |
Official Title: | Phase I/II Trial of Induction Carboplatin/Paclitaxel With Bevacizumab Followed by Concurrent Thoracic Conformal Radiation Therapy With Carboplatin/Paclitaxel, Bevacizumab and Erlotinib in Stage IIIA/B Non-Small Cell Lung Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | January 2006 |
Arms | Assigned Interventions |
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Cohort 1: Experimental
Patients undergo thoracic conformal radiotherapy (TCRT) on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Patients also receive carboplatin IV and paclitaxel IV on days 1, 8, 15, 22, 29, 36, and 43 and bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43.
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Drug: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Procedure: 3-dimensional conformal radiation therapy
Given 5 days a week for 7 weeks
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Cohort 2: Experimental
Patients undergo TCRT and receive carboplatin, paclitaxel, and bevacizumab as in cohort 1. Patients also receive oral erlotinib hydrochloride on days 2-5, 9-12, 16-19, 23-26, 30-33, 37-40, and 44-47.
|
Drug: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: erlotinib hydrochloride
Given orally
Drug: paclitaxel
Given IV
Procedure: 3-dimensional conformal radiation therapy
Given 5 days a week for 7 weeks
|
Cohort 3: Experimental
Patients undergo TCRT and receive carboplatin, paclitaxel, and bevacizumab as in cohort 1. Patients also receive higher doses of oral erlotinib hydrochloride on days 2-5, 9-12, 16-19, 23-26, 30-33, 37-40, and 44-47.
|
Drug: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: erlotinib hydrochloride
Given orally
Drug: paclitaxel
Given IV
Procedure: 3-dimensional conformal radiation therapy
Given 5 days a week for 7 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of non-small cell lung cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, North Carolina | |
Batte Cancer Center at Northeast Medical Center | Recruiting |
CONCORD, North Carolina, United States, 28025 | |
Contact: Contact Person 704-783-1322 | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7295 | |
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 | |
Wake Forest University Comprehensive Cancer Center | Recruiting |
Winston-Salem, North Carolina, United States, 27157-1096 | |
Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 |
Principal Investigator: | David Morris, MD | UNC Lineberger Comprehensive Cancer Center |
Investigator: | Mark A. Socinski, MD | UNC Lineberger Comprehensive Cancer Center |
Study ID Numbers: | CDR0000550142, UNC-LCCC-0511 |
Study First Received: | January 19, 2006 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00280150 |
Health Authority: | Unspecified |
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer recurrent non-small cell lung cancer squamous cell lung cancer |
Thoracic Neoplasms Erlotinib Non-small cell lung cancer Bevacizumab Carboplatin Recurrence Carcinoma |
Respiratory Tract Diseases Lung Neoplasms Paclitaxel Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Protein Kinase Inhibitors |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |