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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00058071
• Other study ID #: CDR0000285700
• Secondary ID: GOG-0192
• Status: Completed
• Phase: Phase 3
• First received: April 7, 2003
• Last updated: July 8, 2013
• Start date: March 2003

Study information

• Verified date: July 2007
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gestational Trophoblastic Disease
• Gestational Trophoblastic Tumor
• Neurotoxicity
• Neurotoxicity Syndromes
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Trophoblastic Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• amifostine trihydrate

Locations

Country	Name	City	State
United States	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Providence Saint Joseph Medical Center - Burbank	Burbank	California
United States	Aultman Hospital Cancer Center at Aultman Health Foundation	Canton	Ohio
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	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	University of Illinois Cancer Center	Chicago	Illinois
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	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	University of Mississippi Cancer Clinic	Jackson	Mississippi
United States	St. Vincent's Medical Center	Jacksonville	Florida
United States	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois
United States	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida
United States	Howard Community Hospital at Howard Regional Health System	Kokomo	Indiana
United States	Moores UCSD Cancer Center	La Jolla	California
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	Florida
United States	Sunrise Hospital and Medical Center	Las Vegas	Nevada
United States	Women's Cancer Center - Lake Mead	Las Vegas	Nevada
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California
United States	Louisville Oncology at Norton Cancer Center	Louisville	Kentucky
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey
United States	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus	New Britain	Connecticut
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Pinehurst	North Carolina
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
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	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	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Siteman Cancer Center at Barnes-Jewish Hospital	St Louis	Missouri
United States	Lakeland Regional Cancer Care Center - St. Joseph	St. Joseph	Michigan
United States	Cancer Care Associates - Midtown Tulsa	Tulsa	Oklahoma
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks
Secondary	Improved quality of life by Functional Assessment of Cancer Therapy-GOG/NTX (FACT-GOG/NTX) at 6, 12, 18, and 24 weeks