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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gestational Trophoblastic Tumor, Neurotoxicity, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: amifostine trihydrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: amifostine trihydrate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks |  |  | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral neuropathy, neurotoxicity, hydatidiform mole, unspecified adult solid tumor, protocol specific