Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	GOG-0192 NCT00058071

Objectives

1. 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.
2. Determine the toxicity of this drug in these patients.

Entry 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)

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

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

Expected Enrollment

A total of 50-100 patients (25-50 per treatment arm) will be accrued for this study.

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Steven Plaxe, MD, Protocol chair		Ph: 619-543-6905

Registry Information
Official Title		A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy
Trial Start Date		2003-03-03
Trial Completion Date		2008-07-20
Registered in ClinicalTrials.gov		NCT00058071
Date Submitted to PDQ		2003-02-13
Information Last Verified		2007-07-06
NCI Grant/Contract Number		CA27469

Back to Top