Bevacizumab Combined With High-Dose Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Patients With Advanced Epithelial Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Event-Free (EF) Rate
研究概览
简要总结
The goal of this clinical research study is to learn if bevacizumab, when given in combination with gemcitabine, docetaxel, melphalan and carboplatin, or with topotecan, cyclophosphamide and melphalan (if you are older than 60 or have an allergy to carboplatin), can help to control ovarian cancer during a stem cell transplant. The safety of this drug combination will also be studied.
详细描述
The Study Drugs:
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
Carboplatin is designed to damage the DNA (the genetic material) of cancer cells, which may cause them to die.
Melphalan is designed to damage the DNA of cells, which may cause cancer cells to die.
Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 - <
- •Patients with advanced ovarian, fallopian or primary peritoneal cancer in second or later complete remission, or untreated or refractory relapse, defined as relapse within 6 months of prior platinum treatment or lack of response to salvage treatment.
- •No evidence of small bowel obstruction, as determined by CT scan of the abdomen and pelvis with oral and rectal contrast, within 30 days before the initiation of study treatment.
- •Adequate renal glomerular and tubular function, as defined by estimated serum creatinine clearance >=60 ml/min, and urinary protein excretion <=500 mg/day.
- •Adequate hepatic function, as defined by serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) <=3 * upper limit of normal (ULN); serum bilirubin and alkaline phosphatase <=2 * ULN or considered not clinically significant.
- •Adequate pulmonary function with Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) >=50% of predicted, corrected for volume or hemoglobin.
- •Adequate cardiac function with left ventricular ejection fraction >=45%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- •Zubrod performance status <2.
排除标准
- •Failure to collect more than 3 * 10e6 CD34+ stem cells/kg body weight
- •Patients with unresolved grade 3 or greater non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the principal investigator.
- •Major surgery within 30 days before the initiation of study treatment
- •Radiotherapy within 21 days prior to initiation of study treatment
- •Patients with active Central Nervous System (CNS) disease.
- •Evidence of acute or chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Principal Investigator and consider liver biopsy.
- •Uncontrolled infection, including HIV or HTLV-1 infection.
- •Aspirin (> 325 mg/day) use within 10 days before initiation of study treatment.
- •Ongoing uncontrolled hypertension (>140/90 mm Hg on medication).
- •Non-healing wound or significant traumatic injury within 30 days before the initiation of study treatment
- •Previous autologous or allogeneic stem cell transplant during the past year.
- •Positive Beta HCG test in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.
研究组 & 干预措施
Bevacizumab + High-Dose Chemotherapy
Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
干预措施: Bevacizumab (Drug)
Bevacizumab + High-Dose Chemotherapy
Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
干预措施: Carboplatin (Drug)
Bevacizumab + High-Dose Chemotherapy
Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
干预措施: Docetaxel (Drug)
Bevacizumab + High-Dose Chemotherapy
Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
干预措施: Gemcitabine (Drug)
Bevacizumab + High-Dose Chemotherapy
Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
干预措施: Melphalan (Drug)
Bevacizumab + High-Dose Chemotherapy
Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
干预措施: Stem Cell Transplant (Procedure)
结局指标
主要结局
Event-Free (EF) Rate
时间窗: Up to 6 Months
Percent of participants free of relapse or disease progression at end of 6 months. Event-free survival estimated from the first day of High-dose chemotherapy (day-6) until tumor progression, relapse, or death from any cause.
次要结局
- Participant Response(Up to 6 months)