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Amifostine as a Toxicity Protectant in Ovarian Cancer in Chemotherapy Treated Patients: A Pilot Phase III Randomized Controlled Trial


Phase 3
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Quality of Life

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Trial Information

Amifostine as a Toxicity Protectant in Ovarian Cancer in Chemotherapy Treated Patients: A Pilot Phase III Randomized Controlled Trial


OBJECTIVES: I. Determine if patients with ovarian epithelial cancer receiving chemotherapy
have significantly fewer neurologic events when treated with amifostine. II. Compare
amifostine vs no chemoprotection in terms of overall incidence of neuropathy, incidence of
neutropenia, infection, and other myelosuppressive events (e.g., leukopenia, anemia, and
thrombocytopenia), length of hospital stay due to infections, and quality of life in this
patient population.

OUTLINE: This is a randomized, parallel, controlled, double blind study. Patients are
randomized to one of two treatment arms. Arm I: Patients receive amifostine IV over 10
minutes, 30 minutes prior to chemotherapy. Arm II: Patients receive a placebo IV over 10
minutes, 30 minutes prior to chemotherapy. Treatment repeats every 3 weeks for 8 courses in
the absence of disease progression or unacceptable toxicity. Quality of life is assessed
prior to courses 1, 4, and 8, and then every 3 months for 1 year. Patients are followed
monthly for 6 months.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed, surgically staged ovarian epithelial
cancer Planned treatment with paclitaxel/carboplatinum chemotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 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 mg/dL SGOT/SGPT no greater than 2.5
times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Other: Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception
during and for 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No
prior radiotherapy Surgery: See Disease Characteristics Other: At least 24 hours since
prior antihypertensives

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

David A. Fishman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 97CC4

NCT ID:

NCT00004166

Start Date:

October 1999

Completion Date:

January 2003

Related Keywords:

  • Ovarian Cancer
  • Quality of Life
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • quality of life
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611