Gestational Trophoblastic Tumor, Neurotoxicity, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
peripheral neuropathy, neurotoxicity, hydatidiform mole, unspecified adult solid tumor, protocol specific
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.
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.
Interventions
DRUGamifostine trihydrate
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Improved quality of life by Functional Assessment of Cancer Therapy-GOG/NTX (FACT-GOG/NTX) at 6, 12, 18, and 24 weeks | — |
Countries
United States
Outcome results
None listed