Pemetrexed Disodium and Bevacizumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Pemetrexed Disodium (ALIMTA®) Plus Bevacizumab in Patients With Stage IIIB Pleural Effusion or Stage IV Non-Small Cell Lung Cancer (Second-Line Treatment)|
- Proportion of progression-free patients at 3 months [ Designated as safety issue: No ]
- Response (complete and partial) as assessed by RECIST criteria [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
- 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.
- 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.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
Show 248 Study Locations
|Study Chair:||Alex A. Adjei, MD, PhD||Roswell Park Cancer Institute|
|Investigator:||Donald B. Wender, MD, PhD||St. Luke's Regional Medical Center|
|Study Chair:||Ralph G. Zinner, MD||M.D. Anderson Cancer Center|