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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Amifostine Versus No Treatment For Platinum-Induced Peripheral Neuropathy in Patients With Cancer

Basic Trial Information

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

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Persistent peripheral neuropathy symptoms lasting at least 3 months but not longer than 3 years
• Not scheduled to receive chemotherapy for at least 4 months
• No previous amifostine
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. Patients in group one will receive an infusion or an injection of amifostine three times a week for 12 weeks. They will then be observed for 12 weeks. Patients in group two will receive no treatment. After 24 weeks, patients in group two may receive amifostine as in group one. Quality of life will be assessed periodically. Patients will be evaluated at 6 and 12 weeks after completing treatment, every 3 months for 2 years, every 6 months for 3 years, and once a year thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

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

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