RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, 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 pemetrexed disodium together with bevacizumab may be an effective treatment for non-small cell lung cancer. PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.
OBJECTIVES: Primary * Assess the 3 month progression-free survival rate of the combination of pemetrexed disodium with bevacizumab in a patient population with stage IIIB (due to pleural effusion) or IV non-small cell lung cancer. Secondary * Determine the tumor response rate in these patients. * Determine the effect of pemetrexed disodium in combination with bevacizumab on overall survival and duration of response in these patients. * Determine the toxicity profile of this drug regimen in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Providence Cancer Center
Anchorage, Alaska, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Eden Medical Center
Castro Valley, California, United States
Saint Rose Hospital
Hayward, California, United States
Proportion of progression-free patients at 3 months
Time frame: at 3 months
Response (complete and partial) as assessed by RECIST criteria
Time frame: Up to 5 years
Overall survival
Time frame: Up to 5 years
Progression-free survival
Time frame: Up to 5 years
Duration of response
Time frame: Up to 5 years
Time to treatment failure
Time frame: Up to 5 years
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