Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer
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.
|Gestational Trophoblastic Tumor Neurotoxicity Peripheral Neuropathy Unspecified Adult Solid Tumor, Protocol Specific||Drug: amifostine trihydrate||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy|
- Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks
- Improved quality of life by Functional Assessment of Cancer Therapy-GOG/NTX (FACT-GOG/NTX) at 6, 12, 18, and 24 weeks
|Study Start Date:||March 2003|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058071
Show 57 Study Locations
|Study Chair:||Steven C. Plaxe, MD||University of California, San Diego|