Breast Cancer Clinical Trial
Official title:
Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy
Verified date | October 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | May 2007 |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Christus St. Frances Cabrini Center for Cancer Care | Alexandria | Louisiana |
United States | CCOP - Columbus | Columbus | Ohio |
United States | CCOP - Central Illinois | Decatur | Illinois |
United States | CCOP - Grand Rapids | Grand Rapids | Michigan |
United States | University of Texas M.D. Anderson CCOP Research Base | Houston | Texas |
United States | CCOP - Kalamazoo | Kalamazoo | Michigan |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin |
United States | All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine | Wisconsin |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Cancer Research for the Ozarks | Springfield | Missouri |
United States | CCOP - Northwest | Tacoma | Washington |
United States | CCOP - Scott and White Hospital | Temple | Texas |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | CCOP - Wichita | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale | 11-item FACT/GOG-NTX questionnaire completed weekly following chemotherapy treatment. | 12 weeks | Yes |
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