Amifostine in Treating Women With Ovarian, Peritoneal, Cervical, Fallopian Tube, Uterine, or Endometrial Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cervical Cancer; Endometrial Cancer; Fallopian Tube Cancer; Neurotoxicity; Ovarian Cancer; Peritoneal Cavity Cancer; Sarcoma
Intervention: amifostine trihydrate (Drug); cisplatin (Drug); paclitaxel (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Gynecologic Oncology Group Official(s) and/or principal investigator(s):
David H. Moore, MD, Study Chair, Affiliation: Indiana University Melvin and Bren Simon Cancer Center
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells
from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of amifostine in reducing the risk of side
effects caused by cisplatin and paclitaxel in treating women who have ovarian, peritoneal,
cervical, fallopian tube, uterine, or endometrial cancer.
Clinical Details
Official title: A Limited Access Trial Using Amifostine for Protection Against Cisplatin and 3-Hour Paclitaxel-Induced Neurotoxicity
Study design: Supportive Care
Detailed description:
OBJECTIVES: I. Determine the efficacy of amifostine in reducing significant peripheral
neuropathy in women with ovarian, peritoneal, cervical, fallopian tube, uterine, or
endometrial cancer treated with cisplatin and paclitaxel. II. Determine the proportion of
patients on this regimen who experience significant peripheral neuropathy 3 months after
completing chemotherapy. III. Assess the overall toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 3 hours, amifostine IV over 10 minutes, and
cisplatin IV over 90 minutes. Treatment repeats every 3 weeks for 6 courses in the absence of
disease progression or unacceptable toxicity. Neurotoxicity is assessed and vibration
perception threshold testing is performed prior to each course of chemotherapy and at 3
months following the last treatment. Patients are followed every 3 months for 2 years, then
every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 29-59 patients will be accrued for this study within 18-36
months.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
DISEASE CHARACTERISTICS: Ovarian, primary peritoneal, cervical, or fallopian tube
carcinoma, uterine sarcoma, or endometrial adenocarcinoma for which the proposed treatment
is cisplatin plus paclitaxel Must be ineligible for a higher priority GOG protocol
PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-3 Life expectancy:
Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1. 5 times upper
limit of normal (ULN) AST and alkaline phosphatase no greater than 3 times ULN Renal:
Creatinine no greater than 2. 0 mg/dL Cardiovascular: No hypertension for which medication
cannot be discontinued for 24 hours through the day of each chemotherapy treatment Other:
No history of neuropathy (e. g., diabetic neuropathy) No significant infection Prior
malignancy allowed if disease free for at least 12 months No physical disabilities
precluding vibration perception threshold testing of the upper and lower extremity (e. g.,
amputation, paraplegia)
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for ovarian, primary peritoneal, or fallopian tube carcinoma, uterine sarcoma,
or endometrial adenocarcinoma Endocrine therapy: Not specified Radiotherapy: No prior
radiotherapy except for cervical carcinoma Surgery: Not specified
Locations and Contacts
Chao Family Comprehensive Cancer Center, Orange, California 92868, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington, District of Columbia 20007, United States
Emory University Hospital - Atlanta, Atlanta, Georgia 30322, United States
University of Chicago Cancer Research Center, Chicago, Illinois 60637, United States
Indiana University Cancer Center, Indianapolis, Indiana 46202-5265, United States
Washington University School of Medicine, Saint Louis, Missouri 63110, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina 27599-7295, United States
Cleveland Clinic Cancer Center, Cleveland, Ohio 44195, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 1998
Last updated: May 23, 2008
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