A Phase II Trial of Pemetrexed, Gemcitabine, and Bevacizumab Every Two Weeks in Chemotherapy-Naive Patients With Stages IIIB/IV Non- Squamous, Non-Small Cell Lung Cancer (NSCLC)
- 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.
- 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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival will be defined as the time from the first day of treatment until the date that progressive disease (PD), symptomatic deterioration, or death due to any cause is first reported. Patients who die without reported prior progression will be considered to have progressed on the day of their death. Patients who did not progress will be censored at the day of last tumor assessment.
Change in tumor size from baseline beginning with cycle 4 then every 4 cycles thereafter.
Antoinette J. Wozniak, MD
Barbara Ann Karmanos Cancer Institute
United States: Food and Drug Administration
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|