Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer
NCT ID: NCT00058071
Last Updated: 2013-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2003-03-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying amifostine to see how well it works compared to observation in relieving numbness, tingling, and other symptoms of peripheral neuropathy in patients who have received platinum-based chemotherapy (such as cisplatin or carboplatin) for cancer.
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Detailed Description
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* Determine, preliminarily, whether amifostine is superior to no treatment, in terms of improving the symptoms and/or objective findings of platinum-induced peripheral neuropathy, in patients with cancer.
* Determine the toxicity of this drug in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive amifostine IV or subcutaneously over 3 minutes on days 1, 3, and 5. Treatment continues for 12 weeks in the absence of unacceptable toxicity. Patients are observed for 12 weeks.
* Arm II: Patients are observed for 24 weeks. After 24 weeks patients may cross over to treatment as in arm I.
Quality of life is assessed at baseline and then at 6, 12, 18, and 24 weeks after study entry.
Patients are followed at 6 and 12 weeks after study treatment, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 50-100 patients (25-50 per treatment arm) will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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amifostine trihydrate
Eligibility Criteria
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Inclusion Criteria
* Prior therapy with platinum-based chemotherapy regimen for a malignancy
* Treatment with other agents, including paclitaxel, allowed
* Grade 2 or greater peripheral neuropathy (numbness, tingling, pain in the distal extremities) attributed to prior platinum-based chemotherapy
* Must have persisted and be stable for 3-36 months after completion of chemotherapy
* Duration of neuropathy no more than 3 years
* No other possible causes for the neuropathy (e.g., alcoholism, diabetes, or peripheral vascular disease)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* GOG 0-3
Life expectancy
* At least 6 months
Hematopoietic
* Not specified
Hepatic
* Bilirubin no greater than 2.0 mg/dL
Renal
* Creatinine no greater than 2.0 mg/dL
* Calcium at least lower limit of normal
Cardiovascular
* No hypotension
* No history of cerebrovascular accident
Other
* No other significant comorbid medical conditions that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* No concurrent chemotherapy
* No chemotherapy (including paclitaxel, cisplatin, and carboplatin) for at least 4 months after study entry
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 24 hours since prior antihypertensive medications
* No prior amifostine
* Prior treatment on a GOG treatment protocol allowed
* No concurrent monoamine oxidase inhibitors
* No concurrent neurotoxic agents during and for at least 6 months after study entry
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Steven C. Plaxe, MD
Role: STUDY_CHAIR
University of California, San Diego
Locations
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Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
Moores UCSD Cancer Center
La Jolla, California, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States
St. Vincent's Medical Center
Jacksonville, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Howard Community Hospital at Howard Regional Health System
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Louisville Oncology at Norton Cancer Center
Louisville, Kentucky, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Women's Cancer Center - Lake Mead
Las Vegas, Nevada, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States
Countries
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Other Identifiers
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GOG-0192
Identifier Type: -
Identifier Source: secondary_id
CDR0000285700
Identifier Type: -
Identifier Source: org_study_id
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