A Phase II Study of Gemcitabine/Carboplatin/Bevacizumab in Platinum Sensitive Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding.
研究概览
简要总结
The purpose of this study is to test the effectiveness, safety and tolerability of the drug combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal cancer.
详细描述
In this study participants will receive the drug combination gemcitabine/carboplatin and bevacizumab once every two weeks. As long as there is evidence that the tumor is not growing and the participant is not experiencing any unacceptable side effects, participation can continue up to 2 years. The study is being done to find the effectiveness, safety and tolerability of this combination of chemotherapy drugs. Bevacizumab affects the growth of new blood vessels in the body. It is part of this study to see if stopping the growth of new blood vessels in the body will help stop the growth and the spread of cancer. The other two chemotherapy drugs, gemcitabine and carboplatin, are currently being used together for the treatment of ovarian cancer.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cancer of the ovaries, fallopian tube or abdominal lining has come back after more than 6 months from the last platinum based chemotherapy treatment.
- •Disease must be detected by CT or CA125 level must be elevated or cancerous ascites must be present.
- •History of at least one therapy of platinum based chemotherapy.
排除标准
- •Participation in another experimental drug study
- •Heart disease or high blood pressure
- •History of a stroke within the past 6 months
- •Vascular disease, or bleeding problems
- •Brain cancer
- •Major Surgical Procedure within 28 days prior to start date
- •Minor surgical procedures within 7 days prior to start date
- •Pregnant or lactating
- •Abdominal or bowel problems like bleeding
- •History of abdominal fistula, GI perforation or Intra-abdominal abscess
- •Serious, non-healing wound, ulcer or bone fracture
- •Acute hepatitis
- •Active infections requiring antibiotics
- •Inability to comply with study or follow up procedures
研究组 & 干预措施
Gemcitabine/carboplatin/bevacizumab
A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
干预措施: Bevacizumab (Drug)
Gemcitabine/carboplatin/bevacizumab
A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
干预措施: Gemcitabine (Drug)
Gemcitabine/carboplatin/bevacizumab
A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding.
时间窗: up to 6 months
Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation.
次要结局
- Overall Survival for Patients Treated With the Regimen.(To progression of Disease)
研究者
Larry Copeland
Principal Investigator
Ohio State University Comprehensive Cancer Center