Platinum-Gemcitabine-Avastin (PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
To evaluate progression-free survival with two chemotherapy regimens on platinum-resistant/refractory ovarian and peritoneal carcinoma
详细描述
This study will evaluate progression-free survival (PFS)for the regimen of gemcitabine and bevacizumab with or without a platinum agent on platinum-resistant/refractory ovarian and peritoneal 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
- Single (Participant)
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
- •Patients ≥ 18 years of age with histologically confirmed, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
- •Disease progression during or within 6 months of previous platinum-based chemotherapy including the following 4 categories:
- •Primary platinum-refractory: Previously untreated patients who do not achieve at least a partial response to platinum-based chemotherapy
- •Primary platinum-resistant: Previously untreated patients who have achieved at least a partial response to platinum-based chemotherapy but experience a relapse within a period of 6 months of its conclusion
- •Secondary platinum-refractory: Previously treated patients have a relapse 6 months after the conclusion of chemotherapy, but fail to achieve at least a partial response
- •Secondary platinum-resistant: Previously treated patients have a relapse 6 months after the conclusion of chemotherapy, achieve at least a partial response with platinum-based therapy as 2nd-line therapy, but experience relapse within 6 months
- •Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2 and a life expectancy >3 months.
- •Absolute neutrophil count > 1500 mm^3, platelet count ≥ 100×10^9 L, hemoglobin ≥ 8.5 g/dL
- •Serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
- •No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator
- •At least three (3) weeks from prior chemotherapy
排除标准
- •Inadequate renal function with a calculated creatinine clearance less than 51 mL/min
- •Uncontrolled cardiac disease, congestive heart failure, angina, or hypertension
- •Myocardial infarction or unstable angina within 2 months of treatment
- •Known human immunodeficiency virus (HIV) infection or chronic active Hepatitis B or C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol)
- •Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks, pulmonary embolism within the past 6 months
- •Bleeding diathesis or significant coagulopathy
- •Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug
- •Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug
- •History of fistula, GI perforation, or intrabdominal abscess
- •Serious non-healing wound, ulcer, or bone fracture
- •clinical signs or symptoms of GI obstruction and/or requirement for parenteral hydration or nutrition
- •Known CNS disease except for treated brain metastasis
- •Known platinum drug allergy
- •Prior treatment with Platinum + Gemcitabine + Avastin, Gemcitabine + Avastin or Gemcitabine alone
- •Prior treatment with more than three (3) lines of chemotherapy including adjuvant chemotherapy
- •Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug
- •Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
- •Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
研究组 & 干预措施
Platinum, Gemcitabine and Bevacizumab
Platinum:
- Carboplatin* on day 1
*If a patient is allergic to carboplatin, then give 2. Cisplatin** on day 1
**If a patient is allergic to cisplatin and carboplatin, then give 3. Oxaliplatin on day 1
Gemcitabine on day 1 only
Bevacizumab on day 1
干预措施: Gemcitabine (Drug)
Platinum, Gemcitabine and Bevacizumab
Platinum:
- Carboplatin* on day 1
*If a patient is allergic to carboplatin, then give 2. Cisplatin** on day 1
**If a patient is allergic to cisplatin and carboplatin, then give 3. Oxaliplatin on day 1
Gemcitabine on day 1 only
Bevacizumab on day 1
干预措施: Bevacizumab (Drug)
Platinum, Gemcitabine and Bevacizumab
Platinum:
- Carboplatin* on day 1
*If a patient is allergic to carboplatin, then give 2. Cisplatin** on day 1
**If a patient is allergic to cisplatin and carboplatin, then give 3. Oxaliplatin on day 1
Gemcitabine on day 1 only
Bevacizumab on day 1
干预措施: Carboplatin (Drug)
Platinum, Gemcitabine and Bevacizumab
Platinum:
- Carboplatin* on day 1
*If a patient is allergic to carboplatin, then give 2. Cisplatin** on day 1
**If a patient is allergic to cisplatin and carboplatin, then give 3. Oxaliplatin on day 1
Gemcitabine on day 1 only
Bevacizumab on day 1
干预措施: Cisplatin (Drug)
Platinum, Gemcitabine and Bevacizumab
Platinum:
- Carboplatin* on day 1
*If a patient is allergic to carboplatin, then give 2. Cisplatin** on day 1
**If a patient is allergic to cisplatin and carboplatin, then give 3. Oxaliplatin on day 1
Gemcitabine on day 1 only
Bevacizumab on day 1
干预措施: Oxaliplatin (Drug)
Gemcitabine and Bevacizumab
Gemcitabine on days 1 and 8
Bevacizumab on day 1
干预措施: Gemcitabine (Drug)
Gemcitabine and Bevacizumab
Gemcitabine on days 1 and 8
Bevacizumab on day 1
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: One Year
Evaluate progression-free survival between the two regimens.
次要结局
未报告次要终点