Lung Cancer Clinical Trial
Official title:
Amifostine (Ethyol) as a Protectant in Metastatic Ovarian and Non-Small Cell Lung Cancer in Paclitaxel/Carboplatin-Treated Patients: A Comparative Trial
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug and giving the drugs in different
combinations may kill more tumor cells.
PURPOSE: Randomized phase II double-blinded trial to study the effectiveness of paclitaxel
and carboplatin given with either amifostine or placebo in patients with metastatic stage
III or stage IV ovarian cancer or metastatic stage III or stage IV non-small cell lung
cancer.
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.
;
Primary Purpose: Supportive Care
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