Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00058071

Purpose

RATIONALE: Amifostine may be effective in relieving numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether amifostine is effective in treating peripheral neuropathy in patients who have received chemotherapy for cancer.

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.

Condition	Intervention	Phase
Gestational Trophoblastic Tumor Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific	Drug: amifostine trihydrate	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
Official Title:	A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Peripheral Nerve Disorders

Drug Information available for: Amifostine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks

Secondary Outcome Measures:

Improved quality of life by Functional Assessment of Cancer Therapy-GOG/NTX (FACT-GOG/NTX) at 6, 12, 18, and 24 weeks

Estimated Enrollment:	100
Study Start Date:	March 2003
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058071

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Locations

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
United States, Connecticut
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
United States, Florida
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States, 33458
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States, 33805
St. Vincent's Medical Center
Jacksonville, Florida, United States, 32204
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
United States, Georgia
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Illinois
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Howard Community Hospital at Howard Regional Health System
Kokomo, Indiana, United States, 46904
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Louisville Oncology at Norton Cancer Center
Louisville, Kentucky, United States, 40202
United States, Michigan
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Nevada
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
Women's Cancer Center - Lake Mead
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States, 28374
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710-1799
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
United States, Oklahoma
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, United States, 74104
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Steven C. Plaxe, MD

University of California, San Diego

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000285700, GOG-0192
Study First Received:	April 7, 2003
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00058071 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

neurotoxicity
hydatidiform mole
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Radiation-Protective Agents
Neoplasms by Histologic Type
Pregnancy Complications, Neoplastic
Pregnancy Complications
Amifostine
Neurotoxicity Syndromes
Physiological Effects of Drugs
Nervous System Diseases
Poisoning

Disorders of Environmental Origin
Protective Agents
Pharmacologic Actions
Neoplasms
Neuromuscular Diseases
Peripheral Nervous System Diseases
Gestational Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
Trophoblastic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2009