Status:
COMPLETED
Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 reducin...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00078845
Start Date
May 1 2004
End Date
May 1 2007
Last Update
October 17 2012
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
2
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
3
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
4
Christus St. Frances Cabrini Center for Cancer Care
Alexandria, Louisiana, United States, 71301