RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, 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 and gemcitabine together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and gemcitabine together with bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer.
OBJECTIVES: Primary * Determine the efficacy of pemetrexed disodium, gemcitabine hydrochloride, and bevacizumab in chemotherapy-naïve patients with stage IIIB or IV nonsquamous cell non-small cell lung cancer. Secondary * Determine the response rate in patients treated with this regimen. * Determine the time to treatment failure in patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes, gemcitabine hydrochloride IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive bevacizumab alone in the absence of disease progression or unacceptable toxicity. After the completion of study treatment, patients are followed periodically for 6 months. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
Pemetrexed disodium 400 mg/m2 intravenously over 10 minutes every 14 days.
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Progression-free Survival (PFS)
RECIST criteria for tumor progression of at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Time frame: Up to 12 months
Number of Participants With Response
The rate of response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Every 8 weeks, for up to 54 months
Number of Participants With Grade 3 or Grade 4 Toxicity
Grade 3/4 toxicity according to the NCI Common Toxicity Criteria v3.0 .
Time frame: Every two weeks, for up to 54 months
Time to Treatment Failure
Time to treatment failure using the Kaplan-Meier method.
Time frame: Every 8 weeks, for up to 54 months
Overall Survival
Overall survival using the Kaplan-Meier method.
Time frame: Every 8 weeks, for up to 54 months
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