Phase II Trial of Novasoy®, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Patients Alive
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genistein may help gemcitabine and erlotinib kill more tumor cells by making tumor cells more sensitive to the drugs.
PURPOSE: This phase II trial is studying how well giving genistein together with gemcitabine and erlotinib works in treating patients with locally advanced or metastatic pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the 6-month survival rate of patients with locally advanced or metastatic pancreatic cancer treated with genistein, gemcitabine hydrochloride, and erlotinib hydrochloride.
Secondary
- Determine the frequency of objective tumor response rate in these patients.
- Determine the time to treatment failure in these patients.
- Determine the effect of baseline expression of pAKT and activation of NF-kappaB on survival of patients treated with this regimen.
- Determine the overall time to disease progression in these patients.
- Estimate the quantitative and qualitative toxicities of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 120 Years（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
Novasoy®, Gemcitabine & Erlotinib
Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28
干预措施: genistein (Dietary Supplement)
Novasoy®, Gemcitabine & Erlotinib
Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28
干预措施: erlotinib hydrochloride (Drug)
Novasoy®, Gemcitabine & Erlotinib
Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Patients Alive
时间窗: at 6 months
Median Overall Survival Estimate
时间窗: up to 17 months
次要结局
- Grade 3 or Higher Toxicity Evaluation(First day of each cycle)
- Response Duration(Every 8 weeks)
- pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation(At start of study)
- Overall Objective Response Rate (Complete and Partial Response)(Every 8 weeks)
- Time to Treatment Failure(Every 8 weeks)
- Time to Progression(Every 8 weeks)