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

Brief Title

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

Official Title

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

Brief 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.

Detailed Description

      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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Progression-free Survival (PFS) at 6-months

Secondary Outcome

 Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease)

Condition

Ovarian Cancer

Intervention

RAD001

Study Arms / Comparison Groups

 Rad001/Bevacizumab

Description:  Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

September 2010

Completion Date

December 2014

Primary Completion Date

January 2014

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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Robert Edwards, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01031381

Organization ID

09-01-RAD001BEV

Responsible Party

Principal Investigator

Study Sponsor

University of Pittsburgh

Collaborators

 Novartis Pharmaceuticals

Study Sponsor

Robert Edwards, MD, Principal Investigator, University of Pittsburgh, Magee-Womens Hospital, Gynecologic Oncology Division

Verification Date

January 2016