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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00234052 |
RATIONALE: Drugs used in chemotherapy, such as carboplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: bevacizumab Drug: carboplatin Drug: pemetrexed disodium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Carboplatin and Pemetrexed Plus Bevacizumab in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | June 2005 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with complete response, partial response, or stable disease continue to receive pemetrexed disodium and bevacizumab in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 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* or cytologically* confirmed non-small cell lung cancer
Any histology, except squamous cell carcinoma, allowed
Meets 1 of the following stage criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg)
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation
No concurrent administration of any of the following:
NSAIDs known to inhibit platelet function, including any of the following:
United States, Illinois | |
Advocate Lutheran General Cancer Care Center | |
Park Ridge, Illinois, United States, 60068-1174 | |
Evanston Northwestern Healthcare - Evanston Hospital | |
Evanston, Illinois, United States, 60201-1781 | |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
Harvey, Illinois, United States, 60426 | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
Chicago, Illinois, United States, 60611-3013 | |
Rush Cancer Institute at Rush University Medical Center | |
Chicago, Illinois, United States, 60612 |
Study Chair: | Jyoti D. Patel | Robert H. Lurie Cancer Center |
Responsible Party: | Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Jyoti D. Patel ) |
Study ID Numbers: | CDR0000446078, NU-04L2 |
Study First Received: | October 5, 2005 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00234052 |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Adenocarcinoma, Bronchiolo-Alveolar Carboplatin Bevacizumab Recurrence Carcinoma Folic Acid |
Pemetrexed Adenocarcinoma of lung Respiratory Tract Diseases Lung Neoplasms Lung Diseases Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Antimetabolites Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Folic Acid Antagonists Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |