Trial Information

Amifostine (Ethyol) as a Protectant in Metastatic Ovarian and Non-Small Cell Lung Cancer in Paclitaxel/Carboplatin-Treated Patients: A Comparative Trial

OBJECTIVES: I. Determine whether patients with metastatic ovarian and non-small cell lung
cancer receiving carboplatin and paclitaxel have significantly fewer neuropathic events when
treated with amifostine.

OUTLINE: This is a randomized, parallel group, double blind, controlled study. Patients are
randomized to either the amifostine or control group. All patients receive intravenous
paclitaxel over 3 hours, followed by carboplatin once every 3 weeks for 6 cycles. Patients
who are randomized to the amifostine group receive intravenous amifostine administered as a
15 minute infusion 30 minutes prior to paclitaxel therapy. Patients randomized to the
control group receive an intravenous placebo solution. Patients are discontinued from the
study if they have disease progression or unacceptable toxic effects after 2 cycles of
treatment. Patients are followed monthly for 8 months post treatment.

PROJECTED ACCRUAL: A total of 80 patients will be accrued (40 with advanced ovarian cancer
and 40 with advanced non-small cell lung cancer) within 2 years.