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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00369551 |
RATIONALE: 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 tumor cells 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with paclitaxel, carboplatin, and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with paclitaxel, carboplatin, and radiation therapy to the chest works in treating patients with locally advanced non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: bevacizumab Drug: carboplatin Drug: paclitaxel Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Safety and Feasibility Study of Bevacizumab With Paclitaxel, Carboplatin and Chest Radiotherapy in Patients With Locally Advanced Non-Small Lung Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | August 2005 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
After study completion, patients are followed periodically for 36 months.
PROJECTED ACCRUAL: A total of 40 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 non-small cell lung carcinoma (NSCLC) meeting the following criteria:
The following subtypes are eligible:
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
No clinically significant cardiovascular disease, including any of the following:
No uncontrolled intercurrent illness including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
No concurrent treatment with full-dose anticoagulation
Low-dose anticoagulants (e.g., warfarin) to maintain patency of central venous catheter allowed provided all of the following criteria are met:
Study ID Numbers: | CDR0000491998, UCCRC-14576A, NCI-7213 |
Study First Received: | August 24, 2006 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00369551 |
Health Authority: | United States: Food and Drug Administration |
stage IIIB non-small cell lung cancer stage IIIA non-small cell lung cancer adenocarcinoma of the lung |
bronchoalveolar cell lung cancer large cell lung cancer stage II non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Adenocarcinoma, Bronchiolo-Alveolar Carboplatin Bevacizumab Carcinoma Adenocarcinoma of lung |
Respiratory Tract Diseases Lung Neoplasms Paclitaxel Lung Diseases Adenocarcinoma 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 Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |