Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer

Condition(s) targeted: Gestational Trophoblastic Tumor; Neurotoxicity; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: amifostine trihydrate (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Gynecologic Oncology Group

Official(s) and/or principal investigator(s):
Steven C. Plaxe, MD, Study Chair, Affiliation: University of California, San Diego

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.

Official title: A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy

Study design: Supportive Care, Randomized, Active Control

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

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California 90095-1781, United States

Moores UCSD Cancer Center, La Jolla, California 92093-0658, United States

Providence Saint Joseph Medical Center - Burbank, Burbank, California 91505, United States

George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus, New Britain, Connecticut 06050, United States

Ella Milbank Foshay Cancer Center at Jupiter Medical Center, Jupiter, Florida 33458, United States

Lakeland Regional Cancer Center at Lakeland Regional Medical Center, Lakeland, Florida 33805, United States

St. Vincent's Medical Center, Jacksonville, Florida 32204, United States

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida 33136, United States

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia 31403-3089, United States

Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois 61801, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

Hinsdale Hematology Oncology Associates, Hinsdale, Illinois 60521, United States

Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey, Illinois 60426, United States

Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois 60435, United States

Regional Cancer Center at Memorial Medical Center, Springfield, Illinois 62781-0001, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611-3013, United States

Rush-Copley Cancer Care Center, Aurora, Illinois 60507, United States

University of Illinois Cancer Center, Chicago, Illinois 60612-7243, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana 46350, United States

Elkhart General Hospital, Elkhart, Indiana 46515, United States

Howard Community Hospital at Howard Regional Health System, Kokomo, Indiana 46904, United States

Memorial Hospital of South Bend, South Bend, Indiana 46601, United States

Saint Anthony Memorial Health Centers, Michigan City, Indiana 46360, United States

Saint Joseph Regional Medical Center, South Bend, Indiana 46617, United States

Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa 52242, United States

Louisville Oncology at Norton Cancer Center, Louisville, Kentucky 40202, United States

Lakeland Regional Cancer Care Center - St. Joseph, St. Joseph, Michigan 49085, United States

William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan 48073, United States

University of Mississippi Cancer Clinic, Jackson, Mississippi 39216, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65802, United States

Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri 65807, United States

Siteman Cancer Center at Barnes-Jewish Hospital, St Louis, Missouri 63110, United States

St. John's Regional Health Center, Springfield, Missouri 65804, United States

Sunrise Hospital and Medical Center, Las Vegas, Nevada 89109, United States

Women's Cancer Center - Lake Mead, Las Vegas, Nevada 89102, United States

Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey 08043, United States

Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees, New Jersey 08043, United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey 08053, United States

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States

SUNY Downstate Medical Center, Brooklyn, New York 11203, United States

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center, Pinehurst, North Carolina 28374, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599-7295, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio 43210-1240, United States

Aultman Hospital Cancer Center at Aultman Health Foundation, Canton, Ohio 44710-1799, United States

Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio 45267, United States

Hillcrest Cancer Center at Hillcrest Hospital, Mayfield Heights, Ohio 44124, United States

McDowell Cancer Center at Akron General Medical Center, Akron, Ohio 44307, United States

Mount Carmel Health - West Hospital, Columbus, Ohio 43222, United States

Riverside Methodist Hospital Cancer Care, Columbus, Ohio 43214-3998, United States

Cancer Care Associates - Midtown Tulsa, Tulsa, Oklahoma 74104, United States

Oklahoma University Cancer Institute, Oklahoma City, Oklahoma 73104, United States

Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania 19111-2497, United States

Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania 19001, United States

Avera Cancer Institute, Sioux Falls, South Dakota 57105, United States

Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota 57117-5039, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2003
Last updated: May 23, 2008