NCT01219777已完成1 期
Phase I Evaluation of Intravenous Carboplatin With Weekly Paclitaxel and Bevacizumab in Patients Undergoing Neoadjuvant Chemotherapy for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Ritu Salani1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物
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
- Tolerated Dose
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose (MTD) of intravenous weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo surgery which will allow an objective measure of response to the above regimen as well as assessment of surgical outcomes.
详细描述
Phase I study proposed to evaluate:
- Tolerability of IV regimen carboplatin, paclitaxel and bevacizumab in the neoadjuvant setting prior to surgery.
- Safety/Toxicity of IV regimen in this patient population
- Treatment is Carboplatin area under the concentration curve (AUC) 5, Bevacizumab 15mg/m2, and starting dose of paclitaxel of 60mg/m2 and will be escalated in intervals of 10mg/m2 to a maximum dose of 80mg/m2.
- Patients will receive cycles 1-3 of carboplatin, bevacizumab, and paclitaxel and then cycle 4 will be carboplatin and paclitaxel followed by surgical intervention within 6 weeks of cycle 4.
- Post surgical treatment per physician discretion
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
- 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
- 否
入选标准
- •histology,cytologically diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer
- •FIGO (International Federation of Gynecology and Obstetrics stage III or IV disease
- •GOG (Gynecologic Oncology Group) Performance Status 0,1,2
- •No prior surgery for their malignancy
- •Adequate bone marrow function
- •Platelet count greater than or equal to 100,000
- •Renal Function: Creatinine < 1.5 institutional upper limit normal
- •Hepatic Function: Bilirubin less than 1.5 ULN (upper limit of normal)
- •Hepatic Function: SGOT (serum glutamate oxaloacetate transaminase) and Alkaline Phosphate
- •Neurologic Function: Neuropathy less than CTCAE (Common Toxicity Criteria for Adverse Effects)grade 1
- •Coagulation Functions: INR<1.5 and PTT ,1.2 times the upper limit of normal
- •Measurable disease
排除标准
- •Previous cancer related surgery
- •Received prior chemotherapy, immunotherapy, radiotherapy, hormonal therapy or biologic therapy for their ovarian, fallopian tube or primary peritoneal cancer.
- •Borderline ovarian tumors, recurrent epithelial ovarian or primary peritoneal cancer or non-epithelial ovarian are not eligible.
- •Other cancers within 5 years (other than non-melanoma skin cancer)
- •Acute Hepatitis or end stage liver disease
- •History of prior gastrointestinal perforation
- •Evidence of abdominal free air not explained by paracentesis
- •Sign or symptoms of gastrointestinal obstruction
- •Active bleeding or pathologic conditions that carry high risk of bleeding
- •CNS (Central Nervous System) disease
- •Clinically Significant cardiovascular disease
- •Known hypersensitivity to Chinese Hamster ovary cell products or other recombinant human or humanized antibodies
- •Clinically significant proteinuria.
- •Hypertensive crises or hypertensive encephalopathy
- •History of hemoptysis
- •Any non-study related invasive procedure within 28 days fo first date of bevacizumab
- •GOG performance status 3 or 4
- •Patients who are pregnant or nursing.
- •Under the age of 18
- •Received prior treatment of bevacizumab or any anti-VEGF (vascular endothelial growth factor) drug
研究组 & 干预措施
Carboplatin
Experimental
AUC 5.0 or 6.0
干预措施: carboplatin (Drug)
Bevacizumab
Experimental
15 mg/kg
干预措施: Bevacizumab (Drug)
Paclitaxel
Experimental
60-80 mg/m2
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Tolerated Dose
时间窗: Up to 6 months
To determine the maximum tolerated dose of carboplatin AUC5 administered Day 1 Cycles 1-4, weekly paclitaxel 60-80mg/m2 administered on Day 1, 8,and 15 for 3 weeks cycles 1-4, bevacizumab 15mg/kg administered Day 1 Cycles 1-3 prior to surgical intervention.
次要结局
- Toxicity and Response Rates Based on Imaging and Surgical Outcomes(Up to 6 months)
研究者
Ritu Salani
Principal Investigator
Ohio State University Comprehensive Cancer Center
研究点 (1)
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