Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Lung Cancer; Neurotoxicity; Ovarian Cancer; Prostate Cancer; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: amifostine trihydrate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s):
Arthur Forman, MD, Study Chair, Affiliation: M.D. Anderson Cancer Center
Summary
RATIONALE: Amifostine may be effective in reducing pain, numbness, tingling, and other
symptoms of peripheral neuropathy.
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.
Clinical Details
Official title: Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy
Study design: Supportive Care, Open Label
Primary outcome: Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale
Detailed description:
OBJECTIVES:
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- 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
Locations and Contacts
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
CCOP - Central Illinois, Decatur, Illinois 62526, United States
CCOP - Wichita, Wichita, Kansas 67214-3882, United States
Christus St. Frances Cabrini Center for Cancer Care, Alexandria, Louisiana 71301, United States
CCOP - Grand Rapids, Grand Rapids, Michigan 49503, United States
CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States
Cancer Research for the Ozarks, Springfield, Missouri 65807, United States
CCOP - Kansas City, Kansas City, Missouri 64131, United States
CCOP - Columbus, Columbus, Ohio 43215, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States
CCOP - Scott and White Hospital, Temple, Texas 76508, United States
University of Texas M.D. Anderson CCOP Research Base, Houston, Texas 77030-4009, United States
CCOP - Northwest, Tacoma, Washington 98405-0986, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare, Racine, Wisconsin 53405, United States
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin 54449, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: May 2004
Last updated: May 23, 2008
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