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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Amifostine

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