NCT00078845已完成2 期
Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 15
- 主要终点
- Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Amifostine
Experimental
500 mg subcutaneous three times a week on Monday, Wednesday and Friday for 4 weeks.
干预措施: Amifostine (Drug)
结局指标
主要结局
Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale
时间窗: 12 weeks
11-item FACT/GOG-NTX questionnaire completed weekly following chemotherapy treatment.
次要结局
未报告次要终点
研究者
研究点 (15)
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