NCT00004876已完成2 期
A Randomized Study Comparing Carboplatin and Thalidomide With Carboplatin Alone in Patients With Stage Ic - IV Ovarian Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of ovarian cancer by stopping blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with thalidomide works compared to carboplatin alone in treating patients with ovarian epithelial cancer.
详细描述
OBJECTIVES:
- Determine the safety of carboplatin and thalidomide in patients with stage IC-IV ovarian cancer.
- Determine the antiangiogenic effect of thalidomide in this patient population.
- Compare the efficacy of carboplatin with or without thalidomide in this patient population.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive carboplatin IV over 1 hour. Treatment continues every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive carboplatin as in arm I. Patients receive thalidomide orally once daily. Thalidomide treatment continues for up to 24 weeks commencing on the first day of carboplatin therapy and ceasing 4 weeks after the last course of carboplatin.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
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
- Female
- 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
Safety
Response
Markers of angiogenesis
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Combination Chemotherapy With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung CancerLung CancerNCT00006484SWOG Cancer Research Network
已完成
2 期
Carboplatin and Paclitaxel in Treating Older Patients With Metastatic or Recurrent Unresectable Non-small Cell Lung CancerLung CancerNCT00005059Alliance for Clinical Trials in Oncology51
Unknown
2 期
Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal CancerFallopian Tube CancerPrimary Peritoneal Cavity CancerOvarian CancerNCT00045461Ludwig-Maximilians - University of Munich241
已完成
3 期
Surgery Plus Radiation Therapy With or Without Chemotherapy in Treating Children With Primitive Neuroectodermal Tumors of the CNSBrain and Central Nervous System TumorsNCT00003859Societe Internationale d'Oncologie Pediatrique230
已完成
2 期
Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone TherapyProstate CancerNCT00049257Jonsson Comprehensive Cancer Center58