AP5346 for Recurrent/Unresectable Squamous Cell Carcinoma of the Head and Neck: A Pilot Study With Clinical and Biological Endpoints
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Correlation of platinum accumulation in the tumor and tumor DNA with clinical response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as AP5346 and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This randomized clinical trial is studying the dose of AP5346 to see how well it works compared with the dose of oxaliplatin in treating patients with metastatic and/or unresectable recurrent head and neck cancer.
详细描述
OBJECTIVES:
- Compare the delivered-dose of platinum per gram of wet weight from a single dose of AP5346 vs a single dose of oxaliplatin in patients with metastatic and/or unresectable recurrent squamous cell carcinoma of the head and neck (SCCHN).
- Correlate platinum accumulation in the tumor and tumor DNA with clinical response in patients treated with these regimens.
- Correlate platinum accumulation in the tumor and tumor DNA with molecular tumor response as determined by GADD153 expression in patients treated with these regimens.
- Quantify, by immunohistochemistry, the expression of the copper transporters CTR1, ATP7A, and ATP7B in SCCHN tumors and correlate expression of these transporters with tumor platinum levels.
- Determine response in patients treated with AP5346.
- Obtain additional data on the safety of AP5346 in these patients.
OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive AP5346 IV over 2 hours three times daily on days 1 and 15.
- Arm II: Patients receive a single dose of unmodified oxaliplatin IV over 2 hours on day 1.
Beginning on day 29, all patients may receive AP5346 as in arm I. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
结局指标
主要结局
Correlation of platinum accumulation in the tumor and tumor DNA with clinical response
Correlation of platinum accumulation in the tumor and tumor DNA with molecular response as determined by GADD153 expression
Toxicity of AP5346
Delivered-dose of platinum 24 hours after IV injection of a single dose of AP5346 vs a single dose of oxaliplatin
Quantification of expression of CTR1, ATP7A, and ATP7B in squamous cell carcinoma of the head and neck (SCCHN) tumors by immunohistochemistry
Correlation of expression of CTR1, ATP7A, and ATP7B in SCCHN tumors with tumor platinum levels
次要结局
未报告次要终点