Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer



Status:Completed
Conditions:Ovarian Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/13/2015
Start Date:September 2010
End Date:September 2013
Contact:Vicki Gilchrist, RN
Email:gilchristvb@upmc.edu
Phone:412.641.6373

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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

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.

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
We found this trial at
1
site
300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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Pittsburgh, PA
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