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

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 3

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

Treatments: Drug: amifostine trihydrate

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00058071

CDR0000285700

GOG-0192

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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