Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Lung Cancer, Neurotoxicity, Ovarian Cancer

Thank you

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven stage III/IV ovarian or non-small cell lung

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

Type of Study:


Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Robert J. Ignoffo, PharmD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Federal Government

Study ID:




Start Date:

May 1997

Completion Date:

October 1998

Related Keywords:

  • Lung Cancer
  • Neurotoxicity
  • Ovarian Cancer
  • stage III non-small cell lung cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage IV non-small cell lung cancer
  • neurotoxicity
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Ovarian Neoplasms
  • Neurotoxicity Syndromes



UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
Oncology Service of San Francisco General Hospital Medical Center San Francisco, California  94110
UCSF/Mt. Zion Cancer Center San Francisco, California  94115