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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
N/A
Not Enrolling
Both
Lung Cancer, Neurotoxicity, Ovarian Cancer

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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
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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Robert J. Ignoffo, PharmD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000065752

NCT ID:

NCT00003072

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

Name

Location

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