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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00058071
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : July 9, 2013
National Cancer Institute (NCI)
Information provided by:
GOG Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Gestational Trophoblastic Tumor Neurotoxicity Peripheral Neuropathy Unspecified Adult Solid Tumor, Protocol Specific Drug: amifostine trihydrate Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy
Study Start Date : March 2003
Actual Primary Completion Date : December 2007

Primary Outcome Measures :
  1. Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks

Secondary Outcome Measures :
  1. Improved quality of life by Functional Assessment of Cancer Therapy-GOG/NTX (FACT-GOG/NTX) at 6, 12, 18, and 24 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)



  • 18 and over

Performance status

  • GOG 0-3

Life expectancy

  • At least 6 months


  • Not specified


  • Bilirubin no greater than 2.0 mg/dL


  • Creatinine no greater than 2.0 mg/dL
  • Calcium at least lower limit of normal


  • No hypotension
  • No history of cerebrovascular accident


  • No other significant comorbid medical conditions that would preclude study participation


Biologic therapy

  • Not specified


  • 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


  • Not specified


  • Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00058071

Show Show 57 study locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
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Study Chair: Steven C. Plaxe, MD University of California, San Diego
Layout table for additonal information Identifier: NCT00058071    
Other Study ID Numbers: CDR0000285700
First Posted: April 9, 2003    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: July 2007
Keywords provided by GOG Foundation:
peripheral neuropathy
hydatidiform mole
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Peripheral Nervous System Diseases
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Chemically-Induced Disorders
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Pregnancy Complications, Neoplastic
Pregnancy Complications
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs