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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00293332 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, 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 tumor cells by blocking blood flow to the tumor. Giving docetaxel and carboplatin together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together with bevacizumab works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.
Condition | Intervention | Phase |
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Lung Cancer |
Biological: bevacizumab Drug: carboplatin Drug: docetaxel Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Neoadjuvant Therapy With Docetaxel, Carboplatin, and Bevacizumab in Patients With Resectable Early Stage Non-Small Cell Lung Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | December 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive docetaxel IV over 15-60 minutes, carboplatin IV over 30-60 minutes, and bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Approximately 4-6 weeks after completion of chemotherapy, eligible patients with no distant or mediastinal disease progression undergo lobectomy, pneumonectomy, or segmentectomy with standard radical mediastinal lymph node dissection.
NOTE: *Bevacizumab is only administered during courses 1 and 2.
After completion of study treatment, patients are followed periodically for 8 years.
PROJECTED ACCRUAL: A total of 50 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 confirmed non-small cell lung cancer
PATIENT CHARACTERISTICS:
Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria:
No history of serious systemic disease, including any of the following:
Unstable symptomatic arrhythmia requiring medication
No other currently active malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 |
Study Chair: | Sarita Dubey, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000455640, UCSF-04652, UCSF-IIT-12198, UCSF-H5535-25047-01A |
Study First Received: | February 16, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00293332 History of Changes |
Health Authority: | United States: Federal Government |
stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer |
Docetaxel Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer |
Carboplatin Bevacizumab Angiogenesis Inhibitors Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Physiological Effects of Drugs Carboplatin Bevacizumab Angiogenesis Inhibitors Pharmacologic Actions Carcinoma |
Docetaxel Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Growth Inhibitors Angiogenesis Modulating Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |