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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. completion date
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


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
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