NCT00058071已完成3 期
A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 114
- 主要终点
- Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks
研究概览
简要总结
RATIONALE: Amifostine may be effective in relieving numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether amifostine is effective in treating peripheral neuropathy in patients who have received chemotherapy for cancer.
PURPOSE: This randomized phase III trial is studying amifostine to see how well it works compared to observation in relieving numbness, tingling, and other symptoms of peripheral neuropathy in patients who have received platinum-based chemotherapy (such as cisplatin or carboplatin) for cancer.
详细描述
OBJECTIVES:
- Determine, preliminarily, whether amifostine is superior to no treatment, in terms of improving the symptoms and/or objective findings of platinum-induced peripheral neuropathy, in patients with cancer.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive amifostine IV or subcutaneously over 3 minutes on days 1, 3, and 5. Treatment continues for 12 weeks in the absence of unacceptable toxicity. Patients are observed for 12 weeks.
- Arm II: Patients are observed for 24 weeks. After 24 weeks patients may cross over to treatment as in arm I.
Quality of life is assessed at baseline and then at 6, 12, 18, and 24 weeks after study entry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Prior therapy with platinum-based chemotherapy regimen for a malignancy
- •Treatment with other agents, including paclitaxel, allowed
- •Grade 2 or greater peripheral neuropathy (numbness, tingling, pain in the distal extremities) attributed to prior platinum-based chemotherapy
- •Must have persisted and be stable for 3-36 months after completion of chemotherapy
- •Duration of neuropathy no more than 3 years
- •No other possible causes for the neuropathy (e.g., alcoholism, diabetes, or peripheral vascular disease)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •Not specified
- •Bilirubin no greater than 2.0 mg/dL
- •Creatinine no greater than 2.0 mg/dL
- •Calcium at least lower limit of normal
- •Cardiovascular
- •No hypotension
- •No history of cerebrovascular accident
- •No other significant comorbid medical conditions that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •No concurrent chemotherapy
- •No chemotherapy (including paclitaxel, cisplatin, and carboplatin) for at least 4 months after study entry
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •At least 24 hours since prior antihypertensive medications
- •No prior amifostine
- •Prior treatment on a GOG treatment protocol allowed
- •No concurrent monoamine oxidase inhibitors
- •No concurrent neurotoxic agents during and for at least 6 months after study entry
排除标准
- 未提供
结局指标
主要结局
Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks
次要结局
- Improved quality of life by Functional Assessment of Cancer Therapy-GOG/NTX (FACT-GOG/NTX) at 6, 12, 18, and 24 weeks
研究者
研究点 (114)
Loading locations...
相似试验
已完成
2 期
Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid TumorsNeurotoxicityUnspecified Adult Solid Tumor, Protocol SpecificBreast CancerProstate CancerLung CancerOvarian CancerNCT00078845M.D. Anderson Cancer Center24
已完成
2 期
Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung CancerPneumonitisNon-Small Cell Lung CarcinomaEsophagitisNCT00081315MedImmune LLC130
已完成
1 期
Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid LeukemiaLeukemiaAcute Myeloid LeukemiaNCT00086099MedImmune LLC54
已完成
3 期
Amifostine in Treating Patients With Stage II or Stage III Non-small Cell Lung CancerDrug/Agent Toxicity by Tissue/OrganOral ComplicationsRadiation ToxicityLung CancerNCT00003313Radiation Therapy Oncology Group243
Unknown
2 期
A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal ToxicityRectal CancerNCT01586117Chinese Academy of Medical Sciences40