NCT00602082已完成2 期
A Randomised Phase II Study Comparing Capecitabine Plus Streptozocin With or Without Cisplatin Chemotherapy as Treatment for Unresectable or Metastatic Neuroendocrine Tumors
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 34
- 主要终点
- Objective response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as capecitabine, streptozocin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving capecitabine together with streptozocin is more effective with or without cisplatin in treating neuroendocrine tumors.
PURPOSE: This randomized phase II trial is studying giving capecitabine together with streptozocin to see how well it works compared with or without cisplatin in treating patients with unresectable or metastatic neuroendocrine tumors.
详细描述
OBJECTIVES:
Primary
- To determine the objective response rate in patients with neuroendocrine tumors treated with capecitabine and streptozocin with or without cisplatin.
Secondary
- To determine the overall response rate, including both objective and biochemical responses, to these regimens.
- To determine the functional response to these regimens.
- To determine the toxicity of these regimens.
- To identify the optimal drug doses in each regimen to be recommended for a subsequent phase III trial.
- To determine the progression-free and overall survival of patients receiving these regimens.
- To determine the quality of life of these patients.
- To determine molecular markers predictive of response to chemotherapy.
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
Objective response rate
次要结局
- Overall response rate
- Functional response
- Toxicity
- Progression-free survival
- Overall survival
- Molecular markers predictive of response to chemotherapy
- Quality of life
研究者
研究点 (34)
Loading locations...
相似试验
Unknown
2 期
Cisplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients With Esophageal CancerEsophageal CancerNCT00509561Wales Cancer Trials Unit259
已完成
2 期
Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland TumorHead and Neck CancerNCT00079079NCIC Clinical Trials Group34
已完成
1 期
Combination Chemotherapy and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction CancerEsophageal CancerNCT00281788Duke University13
Unknown
2 期
Capecitabine, Panitumumab, and Radiation Therapy With or Without Irinotecan Hydrochloride in Treating Patients Undergoing Surgery for Localized Rectal CancerColorectal CancerNCT00967655Loma Linda Oncology Medical Group, Inc.54
Unknown
2 期
Chemotherapy With or Without Bevacizumab or Lapatinib to Treat Operable Oesophagogastric CancerOesophagogastric CancerNCT00450203Professor David Cunningham1,103