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
50
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