Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00022646
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug and giving the drugs in different ways may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens of pemetrexed disodium plus gemcitabine in treating patients who have locally advanced or metastatic non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
* Compare the tumor response rates in patients with locally advanced or metastatic non-small cell lung cancer treated with 3 different schedules of pemetrexed disodium and gemcitabine.
* Compare the duration of response, time to progressive disease, time to treatment failure, and survival time in patients treated with these regimens.
* Compare the quantitative and qualitative toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, open-label study. Patients are stratified according to stage of disease (IIIB vs IV) and ECOG performance status (0 vs 1). Patients are randomized to one of three treatment arms.
* Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8.
* Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by pemetrexed disodium IV over 10 minutes on day 1.
* Arm III: Patients receive gemcitabine IV over 30 minutes on day 1 and pemetrexed disodium IV over 10 minutes followed by gemcitabine IV over 30 minutes on day 8.
Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive up to 6 additional courses of therapy.
Patients are followed every 2 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study within 20 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 157
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm III: pemetrexed + gemcitabine pemetrexed disodium Patients receive gemcitabine IV over 30 minutes on day 1 and pemetrexed disodium IV over 10 minutes followed by gemcitabine IV over 30 minutes on day 8. Arm II: pemetrexed + gemcitabine gemcitabine hydrochloride Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by pemetrexed disodium IV over 10 minutes on day 1. Arm III: pemetrexed + gemcitabine gemcitabine hydrochloride Patients receive gemcitabine IV over 30 minutes on day 1 and pemetrexed disodium IV over 10 minutes followed by gemcitabine IV over 30 minutes on day 8. Arm I: pemetrexed + gemcitabine gemcitabine hydrochloride Patients receive pemetrexed disodium IV over 10 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8. Arm I: pemetrexed + gemcitabine pemetrexed disodium Patients receive pemetrexed disodium IV over 10 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8. Arm II: pemetrexed + gemcitabine pemetrexed disodium Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by pemetrexed disodium IV over 10 minutes on day 1.
- Primary Outcome Measures
Name Time Method tumor response rate Up to 4 years
- Secondary Outcome Measures
Name Time Method duration of response Up to 4 years time to disease progression Up to 4 years time to treatment failure Up to 4 years survival Up to 4 years
Trial Locations
- Locations (22)
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CentraCare Health Plaza
🇺🇸Saint Cloud, Minnesota, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Medcenter One Health System
🇺🇸Bismarck, North Dakota, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Altru Health Systems
🇺🇸Grand Forks, North Dakota, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States