Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy

Conditions
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Breast Cancer, Lung Cancer, Neurotoxicity, Ovarian Cancer, Prostate Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: Amifostine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amifostine<br>500 mg subcutaneous three times a week on Monday, Wednesday and Friday for 4 weeks. | Drug: Amifostine<br>* 500 mg three times a week.<br>* Other names: amifostine trihydrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurotoxicity, unspecified adult solid tumor, protocol specific, recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent non-small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, limited stage small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent ovarian epithelial cancer, stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer