A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 484
- 主要终点
- Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
研究概览
简要总结
This is a placebo-controlled, randomized, multicenter Phase III study that will evaluate the safety and efficacy of bevacizumab, administered in combination with carboplatin with gemcitabine, in women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Signed Informed Consent Form
- •Age ≥ 18 years
- •Documented ovarian, primary peritoneal, or fallopian tube carcinoma that has recurred
- •No prior chemotherapy in the recurrent setting
- •Measurable disease
- •Recovered from prior radiation therapy or surgery
排除标准
- •Prior chemotherapy treatment for recurrent ovarian, primary peritoneal, or fallopian tube carcinoma
- •History of abdominal fistula, gastrointestinal perforation (GIP), or intra-abdominal abscess
- •Patients with clinical symptoms or signs of gastrointestinal (GI) obstruction or who require parenteral hydration, parenteral nutrition, or tube feeding
- •Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- •Current, recent, or planned participation in an experimental drug study
- •History of systemic bevacizumab (Avastin) or other vascular endothelial growth factor (VEGF) or VEGF receptor-targeted agent use
- •Inadequately controlled hypertension
- •Prior history of hypertensive crisis or hypertensive encephalopathy
- •New York Heart Association Class II or greater congestive heart failure (CHF)
- •History of myocardial infarction or unstable angina
- •History of stroke or transient ischemic attack (TIA)
- •Known central nervous system (CNS) disease except for treated brain metastasis
- •Significant vascular disease or recent peripheral arterial thrombosis
- •History of hemoptysis
- •Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
研究组 & 干预措施
Carboplatin and gemcitabine + bevacizumab
Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
干预措施: Carboplatin (Drug)
Carboplatin and gemcitabine + bevacizumab
Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
干预措施: Gemcitabine (Drug)
Carboplatin and gemcitabine + bevacizumab
Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
干预措施: Bevacizumab (Drug)
Carboplatin and gemcitabine + placebo
Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
干预措施: Carboplatin (Drug)
Carboplatin and gemcitabine + placebo
Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
干预措施: Gemcitabine (Drug)
Carboplatin and gemcitabine + placebo
Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
时间窗: From randomization through September 17, 2010 (up to 3 years, 5 months)
PFS was defined as the time from randomization to disease progression (PD), as determined by the investigator, or death due to any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started; the appearance of 1 or more new lesions; and/or the unequivocal progression of existing non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.
次要结局
- Percentage of Patients Who Had at Least 1 Adverse Event(From randomization through July 19, 2013 (up to 6 years, 3 months))
- Overall Survival(From randomization through July 19, 2013 (up to 6 years, 3 months))
- Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)(From randomization through September 17, 2010 (up to 3 years, 5 months))
- Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)(From randomization through September 17, 2010 (up to 3 years, 5 months))
- Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)(From randomization through September 17, 2010 (up to 3 years, 5 months))