Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00055887
- 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 efaproxiral may make the tumor cells more sensitive to radiation therapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without efaproxiral in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy combined with radiation therapy with or without efaproxiral in treating patients who have stage III non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
* Compare the overall survival of patients with stage IIIA or IIIB non-small cell lung cancer treated with induction chemotherapy followed by radiotherapy with or without efaproxiral.
* Compare time to progression, response rate, and pattern of failure of patients treated with these regimens.
* Determine the safety of efaproxiral in these patients.
* Determine the pharmacokinetics of efaproxiral in these patients.
* Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to chemotherapy regimen, Karnofsky performance status (70-80% vs 90-100%), and disease stage (IIIA vs IIIB).
* Induction therapy phase: Patients receive 1 of the following induction chemotherapy regimens:
* Paclitaxel and carboplatin: Patients receive paclitaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for a total of 2 courses.
* Cisplatin and gemcitabine: Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.
* Cisplatin and vinorelbine: Patients receive cisplatin IV on day 1 and vinorelbine IV on days 1, 8, and either 15 or 22. Treatment repeats every 28 days for a total of 2 courses.
* Randomized phase: Within 42 days after completion of chemotherapy, patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive efaproxiral IV over 30-45 minutes with supplemental oxygen and then undergo concurrent radiotherapy 5 days a week for 7 weeks.
* Arm II: Patients receive supplemental oxygen and undergo radiotherapy as in arm I.
Quality of life is assessed at baseline, on days 1 and 16 of radiotherapy, monthly for 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Patients are followed monthly for 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 659 patients will be accrued for this study.
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
CHUS-Hopital Fleurimont
🇨🇦Fleurimont, Quebec, Canada
Schiffler Cancer Center
🇺🇸Wheeling, West Virginia, United States
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
Sheba Medical Center
🇮🇱Tel Hashomer, Israel
St. Agnes Cancer Center
🇺🇸Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Willis - Knighton Cancer Center
🇺🇸Shreveport, Louisiana, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Soroka University Medical Center
🇮🇱Beer-Sheva, Israel
North Idaho Cancer Center
🇺🇸Coeur d'Alene, Idaho, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Algemeen Ziekenhuis Middelheim
🇧🇪Antwerp, Belgium
McGill University
🇨🇦Montreal, Quebec, Canada
Maisonneuve-Rosemont Hospital
🇨🇦Montreal, Quebec, Canada
Rambam Medical Center
🇮🇱Haifa, Israel
Tel-Aviv Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
Cancer Center at Lexington Clinic
🇺🇸Lexington, Kentucky, United States
Providence Everett Medical Center - Pacific Campus
🇺🇸Everett, Washington, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Hopital Notre- Dame du CHUM
🇨🇦Montreal, Quebec, Canada