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Phase II Study of Subcutaneous Amifostine in Patients With Solid Tumors Who Have Persistent Paclitaxel-Induced Peripheral Neuropathy
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
Basic Trial Information
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Protocol IDs
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Phase II
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Supportive care
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Completed
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18 and over
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NCI
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MDA-CCC-0223
MDA-CCC-0203, MDA-2003-0789, NCT00078845
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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 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.
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 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:
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy - See Disease Characteristics
- No prior cisplatin
- No chemotherapy during and for at least 3 months after study participation
Endocrine therapy Radiotherapy Surgery Other - No concurrent monoamine oxidase inhibitors
Patient Characteristics:
Age Sex Menopausal status Performance status Life expectancy Hematopoietic Hepatic 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
Expected Enrollment 40A total of 20-40 patients will be accrued for this study within 10-20 months. Outcomes Primary Outcome(s)Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale
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.
Trial Contact Information
Trial Lead Organizations University of Texas M.D. Anderson CCOP Research Base | | | | Arthur Forman, MD, Protocol chair | | | |
| Registry Information | | | Official Title | | Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy | | | Trial Start Date | | 2004-05-26 | | | Registered in ClinicalTrials.gov | | NCT00078845 | | | Date Submitted to PDQ | | 2003-08-14 | | | Information Last Verified | | 2007-03-05 | | | NCI Grant/Contract Number | | CA16672 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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