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A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy

Phase 3
18 Years
Not Enrolling
Gestational Trophoblastic Tumor, Neurotoxicity, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy


- 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

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.

Inclusion Criteria


- 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

- 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


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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks

Principal Investigator

Steven C. Plaxe, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Diego


United States: Federal Government

Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

  • Gestational Trophoblastic Tumor
  • Neurotoxicity
  • Peripheral Neuropathy
  • Unspecified Adult Solid Tumor, Protocol Specific
  • peripheral neuropathy
  • neurotoxicity
  • hydatidiform mole
  • unspecified adult solid tumor, protocol specific
  • Peripheral Nervous System Diseases
  • Trophoblastic Neoplasms
  • Neurotoxicity Syndromes
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Gestational Trophoblastic Neoplasms



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