Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00054392
- Lead Sponsor
- Fox Chase Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy such as gemcitabine, carboplatin, and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
* Compare the overall survival of patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with gemcitabine and carboplatin vs gemcitabine and paclitaxel vs paclitaxel and carboplatin.
* Compare the overall response rate and time to progression in patients treated with these regimens.
* Compare the toxic effects of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss within the past 6 months (less than 5% vs at least 5%), disease stage (IIIB vs IV), and brain metastases (present vs absent). Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 15-30 minutes on day 1.
* Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and paclitaxel IV over 3 hours on day 1.
* Arm III: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1.
In all arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 6 weeks during study treatment, and then every 3 months until progressive disease is documented.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 1,134 patients (378 per treatment arm) will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival
- Secondary Outcome Measures
Name Time Method Tumor response rate Time to disease progression Quality of life as measured by the Functional Assessment of Cancer -Lung (FACT-L) questionnaire at baseline, every 6 weeks during study treatment, and then every 3 months thereafter
Trial Locations
- Locations (56)
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
New Hope Cancer and Research Institute - Pomona
🇺🇸Pomona, California, United States
Lawrence and Memorial Hospital
🇺🇸New London, Connecticut, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
Gulf Coast Cancer Treatment Center
🇺🇸Panama City, Florida, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Cancer Center of Indiana
🇺🇸New Albany, Indiana, United States
Scroll for more (46 remaining)Loma Linda University Cancer Institute at Loma Linda University Medical Center🇺🇸Loma Linda, California, United States