A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Gestational Trophoblastic Tumor, Neurotoxicity, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific
Both
Gestational Trophoblastic Tumor, Neurotoxicity, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Outcome Measure:
Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks
Principal Investigator
Steven C. Plaxe, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of California, San Diego
Authority:
United States: Federal Government
Study ID:
CDR0000285700
NCT ID:
NCT00058071
Start Date:
March 2003
Completion Date:
Related Keywords:
- Gestational Trophoblastic Tumor
- Neurotoxicity
- Peripheral Neuropathy
- Unspecified Adult Solid Tumor, Protocol Specific
- peripheral neuropathy
- neurotoxicity
- hydatidiform mole
- unspecified adult solid tumor, protocol specific
- Peripheral Nervous System Diseases
- Trophoblastic Neoplasms
- Neurotoxicity Syndromes
- Demyelinating Diseases
- Polyneuropathies
- Nerve Compression Syndromes
- Neurologic Manifestations
- Gestational Trophoblastic Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
| Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
| Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
| Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
| Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
| Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
| Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
| Sunrise Hospital and Medical Center | Las Vegas, Nevada 89109-2306 |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
| St. John's Regional Health Center | Springfield, Missouri 65804 |
| SUNY Downstate Medical Center | Brooklyn, New York 11203 |
| McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
| Cancer Care Associates - Midtown Tulsa | Tulsa, Oklahoma 74104 |
| Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
| Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
| University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
| University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
| Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
| Women's Cancer Center - Lake Mead | Las Vegas, Nevada 89102 |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
| Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
| Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
| Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
| Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland, Florida 33805 |
| Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
| Howard Community Hospital at Howard Regional Health System | Kokomo, Indiana 46904 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
| FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst, North Carolina 28374 |
| Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
| St. Vincent's Medical Center | Jacksonville, Florida 32203 |
| Louisville Oncology at Norton Cancer Center | Louisville, Kentucky 40202 |
