Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy
- Determine the percentage of patients with solid tumors who have persistent
paclitaxel-induced peripheral neuropathy who benefit, defined as a decrease of at least
20% on their FUNCTIONAL ASSESSMENT OF CANCER THERAPY/ GYNECOLOGIC ONCOLOGY GROUP
NEUROTOXICITY (FACT/GOG-Ntx) FACT-GOG-NTX score, from treatment with subcutaneous
- Determine whether there is sufficient evidence of reversal activity of this drug in
these patients to justify a phase III study.
- Compare the acute toxic effects of this drug administered subcutaneously in these
patients vs IV administrations of this drug historically and/or during the GOG-0192
- Determine the capability of the Weinstein Enhanced Sensory Test to provide objective,
quantitative evidence for improvement in patients who have subjective improvement as
self-reported on the FACT-GOG-NTX scale.
- Determine whether any benefit in patients treated with this drug is transient or lasts
at least 8 weeks.
OUTLINE: This is an open-label, multicenter study.
Patients receive amifostine subcutaneously three times weekly for 4 weeks in the absence of
symptom progression or unacceptable toxicity. Patients achieving a complete or partial
response receive an additional 4 weeks of therapy.
Neuropathy symptoms are assessed using the FACT-GOG-NTX questionnaire administered at
baseline, weekly during therapy, and at 12 weeks and the Weinstein Enhanced Sensory Test
administered at baseline and at 4, 8, and 12 weeks.
Patients are followed at 12 weeks.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 10-20
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale
11-item FACT/GOG-NTX questionnaire completed weekly following chemotherapy treatment.
Arthur Forman, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|Cancer Research for the Ozarks||Springfield, Missouri 65807|
|CCOP - Columbus||Columbus, Ohio 43206|
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|CCOP - Scott and White Hospital||Temple, Texas 76508|
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|CCOP - Marshfield Clinic Research Foundation||Marshfield, Wisconsin 54449|
|All Saints Cancer Center at Wheaton Franciscan Healthcare||Racine, Wisconsin 53405|
|Christus St. Frances Cabrini Center for Cancer Care||Alexandria, Louisiana 71301|
|University of Texas M.D. Anderson CCOP Research Base||Houston, Texas 77030-4009|