Combination Chemotherapy in Treating Patients With Metastatic Ovarian Cancer or Non-small Cell Lung Cancer
Combination Chemotherapy in Treating Patients With Metastatic Ovarian Cancer or Non-small Cell Lung Cancer
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.
DISEASE CHARACTERISTICS: Histologically proven stage III/IV ovarian or non-small cell lung
 cancer

 PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-2 Life Expectancy: Not
 specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
 least 100,000/mm3 Hepatic: Bilirubin no greater than 3.0 mg/dL Renal: Creatinine no greater
 than 2 mg/dL Other: Not pregnant or nursing No history of platinum, paclitaxel or
 amifostine hypersensitivity Prior myelosuppressive events allowed No clinically significant
 ascites

 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
 chemotherapy within 1 month of study Endocrine therapy: Not specified Radiotherapy: No
 prior radiation therapy within 1 month of study Surgery: Not specified