Phase I Study of Intraperitoneal Carboplatin with Intravenous Paclitaxel and Bevacizumab in Patients with Previously Untreated Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
Phase I study to evaluate intraperitoneal carboplatin along with weekly intravenous paclitaxel and bevacizumab in order to establish a tolerable dose and define the toxicity of this regimen in previously untreated patients with advanced ovarian carcinoma.
详细描述
Phase I study with the primary objective to determine the maximum tolerated dose of intraperitoneal carboplatin and intravenous weekly paclitaxel given in combination with intravenous bevacizumab during the second two cycles of treatment in patients with chemo-naive epithelial ovarian, primary peritoneal or fallopian tube cancer. The maximum tolerated dose is defined as the highest dose at which no more than 1 of 6 evaluable patients experiences a dose limiting toxicity during the second two cycles of treatment. Secondary objectives are to determine response rates and to estimate progression free survival and overall survival of this class of 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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Histology diagnoses epithelial ovarian, primary peritoneal, or fallopian tube(Stage II, III or IV)either optimal or suboptimal after initial surgery.
- •All patients must have had appropriate surgery for ovarian, peritoneal, or fallopian tube carcinoma with tissue available for histologic evaluation
- •Histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant brenner tumor, adenocarcinoma NOS.
- •GOG(Gynecologic Oncology Group)performance status of 0,1,2
- •Entered within 12 weeks of most recent surgery performed for diagnosis.
- •Patients must have adequate bone marrow function, renal function,hepatic function, neurologic function, blood coagulation parameters within normal limits
- •Sign approved consent form.
排除标准
- •Patients who have received prior treatment other than initial surgery
- •Patients who have received prior radiotherapy to any portion of their abdominal cavity or pelvis
- •Patients with acute hepatitis or active infection
- •Patients with active bleeding
- •Patients with unstable angina
- •Patients with history of invasive malignancies with the exception of nonmelanoma skin cancer and localized breast cancer.
- •Patients who have received any target therapy or hormonal therapy for management of their ovarian cancer.
- •Patients with synchronous primary endometrial cancer.
- •Patients with epithelial tumors of low malignant potential
- •Serious non healing wound, ulcer or bone fracture.
- •Patients with history or evidence of CNS(central nervous system disease)
- •Patients under 18 years old.
- •Patients who have received prior therapy with anti-VEGF(vascular endothelial growth factor)
- •drug, bevacizumab
- •Patients who have a history of allergic reaction to polysorbate 80.
研究组 & 干预措施
Carboplatin Paclitaxel & Bevacizumab
Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab
干预措施: Paclitaxel (Drug)
Carboplatin Paclitaxel & Bevacizumab
Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab
干预措施: Carboplatin (Drug)
Carboplatin Paclitaxel & Bevacizumab
Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: Every Cycle-28 days
The Maximum Tolerated Dose is defined as the highest dose at which no more than 1 of 6 evaluable patients experiences a dose limiting toxicity.
次要结局
- Response Rate, Progression Free Survival and Overall Survival(Every 3 monthes for 2 years, Every 6 months for 3 years.)
研究者
David O'Malley
Principal Investigator
Ohio State University Comprehensive Cancer Center