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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

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Thank you

Trial Information

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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the progression-free survival at 6 months for RAD001 and bevacizumab in recurrent ovarian, peritoneal, and fallopian tube cancer

Outcome Time Frame:

6 months to 1 year

Safety Issue:


Principal Investigator

Robert Edwards, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh, Magee-Womens Hospital, Gynecologic Oncology Division


United States: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

September 2013

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Recurrent
  • ovarian
  • fallopian tube
  • primary peritoneal
  • cancer
  • Recurrent ovarian, fallopian tube, primary peritoneal cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Magee-Womens Hospital of UPMCPittsburgh, Pennsylvania  15213