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Home > "A" Clinical Trials Conditions > Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors  Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
For Condition: Lung Cancer,Breast Cancer,Prostate Cancer,ovarian epithelial cancer,adult solid tumor,neurotoxicity
Status: Not yet recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Amifostine may be effective in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy. PURPOSE: Phase II trial to study the effectiveness of amifostine in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy in patients who have received paclitaxel for solid tumors.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 - 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 prior amifostine - No concurrent monoamine oxidase inhibitors
Total Enrollment:
Location and Contact Information:
Overall Study Official:
W.Bleyer, Study Chair, M.D. Anderson Cancer Center
Additional Information:
Study ID Numbers: CDR0000330006; MDA-CCC-0203,MDA-2003-0789,MDA-CCC-0223
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078845
Other Adult Solid Tumor Studies:
1. Clinical Trial to Screen Participants Who Are at High Genetic Risk for Ovarian Cancer
2. Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy
3. Interleukin-11 Plus Filgrastim Prior to Peripheral Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease, Breast Cancer, or Other Solid Tumors
4. Comparison of Antibody Therapies in Treating Patients With Graft- Versus-Host Disease That Does Not Respond to Steroid Therapy
5. Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer
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Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
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