Phase II Trial of Carboplatin and Pemetrexed Plus Bevacizumab in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Median time to progression
Approximately every 3 weeks until disease progression
No
Jyoti D. Patel
Study Chair
Robert H. Lurie Cancer Center
United States: Federal Government
NU 04L2
NCT00234052
June 2005
May 2015
Name | Location |
---|---|
Evanston Northwestern Healthcare - Evanston Hospital | Evanston, Illinois 60201-1781 |
Advocate Lutheran General Cancer Care Center | Park Ridge, Illinois 60068-1174 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Rush Cancer Institute at Rush University Medical Center | Chicago, Illinois 60612 |