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

Launched by GYNECOLOGIC ONCOLOGY GROUP · Apr 8, 2003

Keywords

ClinConnect Summary

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: Patien...

Gender

ALL

Eligibility 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