Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Spectrum Pharmaceuticals, Inc
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
