Combination Chemotherapy, Radiation Therapy, and RSR13 in Treating Patients With Stage III Non-small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00004202
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and RSR13 in treating patients who have stage III non-small cell lung cancer that cannot be removed by surgery.
- Detailed Description
OBJECTIVES: I. Determine the one year survival rate, two year survival rate, and median survival rate in patients with locally advanced unresectable non-small cell lung cancer treated with paclitaxel and carboplatin followed by radiotherapy plus RSR13. II. Determine the complete and partial response rates and progression free interval in the chest (radiation portal) of these patients on this regimen. III. Determine the time to disease progression outside of the radiation portal in these patients on this regimen. IV. Determine the toxic effects and adverse events associated with this regimen in these patients.
OUTLINE: This is a multicenter study. Induction chemotherapy: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes every 3 weeks for 2 courses. Radiotherapy: Beginning 3 to 4 weeks after induction chemotherapy, patients receive RSR13 IV over 30 minutes, followed by fractionated radiotherapy 5 times weekly for 6-7 weeks. Patients are followed monthly for 2 months and then every 3 months thereafter until disease progression or death.
PROJECTED ACCRUAL: A total of 46-48 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Cedars-Sinai Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada
Jewish General Hospital - Montreal
🇨🇦Montreal, Quebec, Canada
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Cleveland Clinic Cancer Center
🇺🇸Cleveland, Ohio, United States
Boston Cancer Group
🇺🇸Memphis, Tennessee, United States
Dan Rudy Cancer Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt Cancer Center
🇺🇸Nashville, Tennessee, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Centre Universitaire de Sante de l'Estrie - Site Fleurimont
🇨🇦Fleurimont, Quebec, Canada
Notre Dame Hospital
🇨🇦Montreal, Quebec, Canada