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Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00387374 |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It may also prevent hemoptysis caused by bevacizumab. 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. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with bevacizumab and chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving radiation therapy together with bevacizumab, paclitaxel, and carboplatin works in treating patients with unresectable stage IIIB or stage IV non-small cell lung cancer at high risk for hemoptysis caused by bevacizumab.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Lung Cancer |
Drug: bevacizumab Drug: carboplatin Drug: paclitaxel Procedure: chemoprotection Procedure: management of therapy complications Procedure: pulmonary complications management Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Prophylactic Radiation Therapy for the Prevention of Hemoptysis in Advanced Non Small Cell Lung Cancer in Combination With Bevacizumab, Paclitaxel, and Carboplatin in Patients at High Risk for Bevacizumab-Associated Hemoptysis |
Estimated Enrollment: | 72 |
Study Start Date: | October 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, pilot, multicenter study. Patients are assigned sequentially to 1 of 2 treatment strata.
In both strata, treatment with paclitaxel, carboplatin, and bevacizumab repeats every 21 days for 5-6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease may continue to receive single-agent bevacizumab every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 12 months.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC)* meeting the following criteria:
Squamous cell or mixed squamous-nonsquamous histology with predominant squamous component (≥ 50% squamous) with a primary, unresected endobronchial lesion
Centrally located primary tumor, defined by the following:
Primary tumor of any T stage within or touching the zone of the proximal bronchial tree
Stage IIIB (with malignant pleural effusion) or stage IV disease
At high risk for bevacizumab-associated hemoptysis
PATIENT CHARACTERISTICS:
No serious medical conditions, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 12 months since prior chemotherapy
No prior therapy with angiogenesis, vascular endothelial growth factor (VEGF), or VEGF-receptor inhibitors
No concurrent aspirin (> 325 mg/day) or antiplatelet agents, including dipyramidole, ticlopidine, clopidogrel bisulfate, or cilostazol
No other concurrent anticancer agents or therapies
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
City of Hope Medical Group | |
Pasadena, California, United States, 91105 | |
Contra Costa Regional Medical Center | |
Martinez, California, United States, 94553 | |
Tower Cancer Research Foundation | |
Beverly Hills, California, United States, 90211 | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90089-9181 | |
Veterans Affairs Outpatient Clinic - Martinez | |
Martinez, California, United States, 94553 | |
United States, Pennsylvania | |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 | |
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 |
Study Chair: | Zelanna Goldberg, MD | University of California, Davis |
Investigator: | Natasha Leighl, MD, FRCPC | Princess Margaret Hospital, Canada |
Study ID Numbers: | CDR0000504067, CCC-PHII-78, NCI-7690 |
Study First Received: | October 12, 2006 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00387374 |
Health Authority: | United States: Food and Drug Administration |
hemoptysis drug/agent toxicity by tissue/organ stage IIIB non-small cell lung cancer |
stage IV non-small cell lung cancer squamous cell lung cancer adenosquamous cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Carboplatin Bevacizumab Hemoptysis Hemorrhage Carcinoma Signs and Symptoms |
Respiratory Tract Diseases Lung Neoplasms Paclitaxel Lung Diseases Signs and Symptoms, Respiratory 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 Antimitotic Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Pathologic Processes Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |