Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
NCT ID: NCT00078845
Last Updated: 2012-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2004-05-31
2007-05-31
Brief Summary
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PURPOSE: This phase II trial is studying how well amifostine works in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy in patients who have received paclitaxel for solid tumors.
Detailed Description
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Primary
* 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 amifostine.
* Determine whether there is sufficient evidence of reversal activity of this drug in these patients to justify a phase III study.
Secondary
* 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 study.
* 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 months.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Amifostine
500 mg subcutaneous three times a week on Monday, Wednesday and Friday for 4 weeks.
Amifostine
500 mg three times a week.
Interventions
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Amifostine
500 mg three times a week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of a solid tumor, including, but not limited to the following:
* Ovarian cancer
* Lung cancer
* Prostate cancer
* Breast cancer
* Previously treated with paclitaxel
* Peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities) believed to be caused by paclitaxel only or the combination of paclitaxel and carboplatin
* At least 18 out of 44 on the FACT-GOG-NTX scale
* Persistent neuropathy for at least 2, but no more than 12 months after chemotherapy
* Not improving
* No other possible cause of neuropathy (e.g., alcoholism, diabetes, or peripheral vascular disease)
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Not specified
Menopausal status
* Not specified
Performance status
* Karnofsky 50-100%
Life expectancy
* More than 2 months
Hematopoietic
* Not specified
Hepatic
* Bilirubin ≤ 2.0 mg/dL
Renal
* Creatinine ≤ 2.0 mg/dL
* Calcium ≥ lower limit of normal
Cardiovascular
* See Disease Characteristics
* No prior cerebrovascular accident
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other significant comorbid medical condition that would preclude study participation
* No known sensitivity to aminothiol compounds
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* No prior cisplatin
* No chemotherapy during and for at least 3 months after study participation
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No concurrent monoamine oxidase inhibitors
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Arthur Forman, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Wichita
Wichita, Kansas, United States
Christus St. Frances Cabrini Center for Cancer Care
Alexandria, Louisiana, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Cancer Research for the Ozarks
Springfield, Missouri, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
CCOP - Northwest
Tacoma, Washington, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States
Countries
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Other Identifiers
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MDA-CCC-0223
Identifier Type: -
Identifier Source: secondary_id
MDA-CCC-0203
Identifier Type: -
Identifier Source: secondary_id
MDA-2003-0789
Identifier Type: -
Identifier Source: secondary_id
CDR0000330006
Identifier Type: -
Identifier Source: org_study_id