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

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00058071

Collaborator

National Cancer Institute (NCI) (NIH)

100

Enrollment

Locations

1.8

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Trophoblastic Tumor Neurotoxicity Peripheral Neuropathy Unspecified Adult Solid Tumor, Protocol Specific	Drug: amifostine trihydrate	Phase 3

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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Mar 1, 2003

Actual Primary Completion Date :

Dec 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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