Carboplatin, Pemetrexed Disodium, and Bevacizumab in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Carboplatin and Pemetrexed Plus Bevacizumab in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer|
- Median time to progression [ Time Frame: Approximately every 3 weeks until disease progression ] [ Designated as safety issue: No ]
- Response rate and duration of response [ Time Frame: After 6 cycles of therapy (cycle = 3 weeks) and then after every cycle until disease progression ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: After every cycle of therapy (cycle = 3 weeks) ] [ Designated as safety issue: Yes ]
- Determine overall survival rate [ Time Frame: After every cycle during treatment and then every 3 months x 2 years, then every 6 months x 3 years or until death. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment Arm
Carboplatin + pemetrexed + bevacizumab
5 mg/kg administered intravenously over 90 minutes on day 1 of each cycle (cycle = 3 weeks)
Other Name: AvastinDrug: carboplatin
Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle (1 cycle = 3 weeks)Drug: pemetrexed
Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle (1 cycle = 3 weeks)
Other Name: pemetrexed disodium
- Determine the median time to disease progression in patients with stage IIIB or IV or recurrent non-squamous cell non-small cell lung cancer treated with carboplatin, pemetrexed disodium, and bevacizumab.
- Determine the response rate and duration of response in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234052
|United States, Illinois|
|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|
|Evanston Northwestern Healthcare - Evanston Hospital|
|Evanston, Illinois, United States, 60201-1781|
|Ingalls Cancer Care Center at Ingalls Memorial Hospital|
|Harvey, Illinois, United States, 60426|
|Advocate Lutheran General Cancer Care Center|
|Park Ridge, Illinois, United States, 60068-1174|
|Study Chair:||Jyoti D. Patel||Robert H. Lurie Cancer Center|