Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer
Condition: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma
MeSH terms: Fallopian Tube Neoplasms
Intervention: RAD001; bevacizumab
Intervention description: RAD001 10mg is taken orally (by mouth) once daily on a continuous basis. RAD001 is provided in tablet form and should be taken with a big glass of water on an empty stomach or after a low-fat meal.; bevacizumab will be administered intravenously (IV) once every 14 days.
Intervention MeSH terms: Bevacizumab; Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrent; ovarian; fallopian tube; primary peritoneal; cancer; Recurrent ovarian, fallopian tube, primary peritoneal cancer

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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