Phase II Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer An Investigator-initiated, Single-institution Trial at Magee-Womens Hospital
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS) at 6-months
研究概览
简要总结
This study will investigate the efficacy as well as the safety of RAD001 in combination with bevacizumab for recurrent ovarian, peritoneal, and fallopian tube cancer. RAD001 will be taken orally once daily and bevacizumab will be administered once every 14 days. The study will be conducted over a period of about 3 to 4 years.
详细描述
In this trial, approximately 50 patients will receive the study drug, RAD001 in combination with bevacizumab (Avastin)chemotherapy. RAD001 will be taken orally once daily and bevacizumab will be administered intravenously once every 14 days. In addition to study treatment, a few blood samples and a sample of the patients tumor from a previous surgery if available will be collected for research.
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
- •Patients may or may not have measurable disease. Measurable disease is defined according to RECIST criteria. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation was completed.
- •Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy)
- •Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN.
- •Performance status £ 2
- •Signed informed consent.
排除标准
- •Prior treatment with any investigational drug within the preceding 4 weeks
- •Chronic treatment with systemic steroids or another immunosuppressive agent
- •Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
- •Uncontrolled brain or leptomeningeal metastases
- •Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
- •Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation
- •Uncontrolled diabetes mellitus
- •A known history of HIV seropositivity
- •Impairment of gastrointestinal function or gastrointestinal disease
- •Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)
- •Women who are pregnant or breast feeding, or women able to conceive and unwilling to practice an effective method of birth control.
- •Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
- •Patients with a known hypersensitivity to RAD001 (everolimus), other rapamycins (sirolimus, temsirolimus) or excipients, or bevacizumab
- •Patients with serious non-healing wound, ulcer, or bone fracture.
- •Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
研究组 & 干预措施
Rad001/Bevacizumab
Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.
干预措施: RAD001 (Drug)
Rad001/Bevacizumab
Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.
干预措施: bevacizumab (Drug)
结局指标
主要结局
Progression-free Survival (PFS) at 6-months
时间窗: Up to 36 months (data collection period for the cohort); Up to 6 months for participant
The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
次要结局
- Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease)(Within 4 weeks (28 days) of study treatment initiation (baseline))
研究者
Robert Edwards
Principal Investigator
University of Pittsburgh