Pemetrexed Disodium and Gemcitabine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
- Registration Number
- NCT00407550
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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. Giving pemetrexed disodium together with gemcitabine may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying two different schedules of pemetrexed disodium and gemcitabine to compare how well they work in treating patients with stage IIIB or stage IV non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare response rates in patients with stage IIIB or IV non-small cell lung cancer treated with two different treatment schedules of pemetrexed disodium and gemcitabine hydrochloride.
Secondary
* Compare time-to-event efficacy variables in patients treated with these regimens.
* Compare progression-free and overall survival of patients treated with these regimens.
* Determine the overall toxicity of these regimens in these patients.
OUTLINE: This is a multicenter, open-label, randomized study. Patients are stratified according to disease stage (IIIB vs IV) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1. Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gemzar x2 gemcitabine HCL Treat subjects with 2 dosings/cycle of Gemzar x6 cycles. Gemzar x2 pemetrexed disodium Treat subjects with 2 dosings/cycle of Gemzar x6 cycles. Gemzar x1 pemetrexed disodium Treat subjects with 1 dosing/cycle of Gemzar x9 cycles. Gemzar x1 gemcitabine HCL Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
- Primary Outcome Measures
Name Time Method Number of Patients With Confirmed Responses Two consecutive evaluations at least 6 weeks apart (up to 2 years) Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.
\>
\> Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.
- Secondary Outcome Measures
Name Time Method Overall Survival Death or last follow-up (up to 2 years) Overall survival time was defined as the number of months from registration to the date of death or last follow-up
Progression-free Survival Time from registration to progression or death (up to 2 years) Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.
Adverse Event Gemzar x2 Arm every 21 days, Gemzar x1 Arm every 14 days (up to 2 years) Number of patients that experienced adverse events (grade 4 or more) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0
Trial Locations
- Locations (1)
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States