Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- To evaluate the response rate
研究概览
简要总结
Pancreatic cancer is a devastating disease. Previous research shows a correlation between a specific oncogene change (ras-mutation) and enhanced sensitivity to two chemotherapy drugs combined: gemcitabine and etoposide. This Phase II trial will evaluate this drug combination for locally advanced and metastatic pancreatic cancer.
详细描述
This is a Phase II single-armed study evaluating potential benefits of the gemcitabine and etoposide combination in the treatment of patients with locally advanced or metastatic pancreatic cancer. The study will involve approximately 30-40 adult patients with pancreatic cancer. Response rate, duration of response, overall survival, quality of life and toxicity associated with the combination therapy will be evaluated.
Primary Objective To evaluate the response rate of patients with histologically or cytologically confirmed pancreatic cancer, previously untreated with chemotherapy with the exception of 5FU given as part of an adjuvant regimen, who receive the gemcitabine-etoposide combination therapy.
Secondary Objectives 1. To evaluate the duration of response in the defined study population. 2. To evaluate the overall survival. 3. To evaluate the quality of life associated with this treatment combination.4.To describe the toxicity profile. 5.To collect clinical specimens from the defined study population for the evaluation of potential molecular correlates of diagnosis, disease progression, treatment outcomes, survival, and/or treatment-associated toxicity by proteomics and microarray technologies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patients with locally advanced or metastatic adenocarcinoma of the pancreas.
- •Patients may have received prior immunotherapy, radiation therapy, or surgery, but must be > 4 weeks out from therapy and have recovered fully from its effects.
- •Patients must be 18 years of age or older.
- •Patients must have unidimensional measurements obtainable using RECIST criteria (see Protocol Attachment E).
- •Karnofsky Performance Scale must be 50 or better (see Protocol Attachment A).
- •Patient must have the following hematologic and chemical parameters:
- •ANC > 1,000 cells/mm3
- •Hemoglobin > 9 gm/dL
- •Platelets > 100,000 cells/mm3
- •SGOT/SGPT < 3 x normal, unless there is known liver involvement. Then they must be < 5x normal.
- •Bilirubin < 2.0 mg/dL
- •Creatinine < 2.0 mg/dL
- •Female within childbearing years must use an accepted contraceptive method.
- •Patient must have a life expectancy of at least eight (8) weeks.
- •A signed informed consent must be obtained prior to study entry.
排除标准
- •Previous chemotherapy with the exception of 5FU given as part of an adjuvant regimen.
- •Pregnant or nursing females.
- •Concurrent radiation therapy.
- •Patients with other active neoplasms are ineligible.
- •Patients with serious active infections or other underlying medical conditions, which would impair their ability to receive the treatment as prescribed.
- •Disease Diagnostic Criteria and Staging:
- •Patients must have a histologic or cytologic diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas using standard pathologic criteria.
- •Staging will be according to AJCC criteria.
结局指标
主要结局
To evaluate the response rate
时间窗: study completion
次要结局
- To evaluate the quality of life(study completion)
- To describe the toxicity profile(study completion)
- To evaluate the duration of response(study completion)
- To evaluate the overall survival(study completion)