Clinical trial NCT01031381: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Keywords: Recurrent
ovarian
fallopian tube
primary peritoneal
cancer
Recurrent ovarian, fallopian tube, primary peritoneal cancer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
name: Genentech, Inc.
First posted: 2009-12-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-free Survival (PFS) at 6-months
timeFrame: Up to 36 months (data collection period for the cohort); Up to 6 months for participant
Secondary outcomes:
measure: Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease)
timeFrame: Within 4 weeks (28 days) of study treatment initiation (baseline)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, Magee-Womens Hospital, Gynecologic Oncology Division
name: Robert Edwards, MD
role: PRINCIPAL_INVESTIGATOR
References: