Back to resultsStudy of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer (RADBEV)
Primary Purpose
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RAD001
bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Recurrent, ovarian, fallopian tube, primary peritoneal, cancer, Recurrent ovarian, fallopian tube, primary peritoneal cancer
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
Sites / Locations
- Magee-Womens Hospital of UPMC
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Rad001/Bevacizumab
Arm Description
Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS) at 6-months
The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Secondary Outcome Measures
Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease)
The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Full Information
NCT ID
NCT01031381
First Posted
December 10, 2009
Last Updated
July 19, 2016
Sponsor
University of Pittsburgh
Collaborators
Novartis Pharmaceuticals, Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01031381
Brief Title
Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer
Acronym
RADBEV
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
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Novartis Pharmaceuticals, Genentech, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Keywords
Recurrent, ovarian, fallopian tube, primary peritoneal, cancer, Recurrent ovarian, fallopian tube, primary peritoneal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rad001/Bevacizumab
Arm Type
Other
Arm Description
Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.
Intervention Type
Drug
Intervention Name(s)
RAD001
Other Intervention Name(s)
everolimus, derivative of rapamycin
Intervention Description
RAD001 10mg is taken orally (by mouth) once daily on a continuous basis. RAD001 is provided in tablet form and should be taken with a big glass of water on an empty stomach or after a low-fat meal.
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
bevacizumab will be administered intravenously (IV) once every 14 days.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) at 6-months
Description
The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Time Frame
Up to 36 months (data collection period for the cohort); Up to 6 months for participant
Secondary Outcome Measure Information:
Title
Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease)
Description
The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Time Frame
Within 4 weeks (28 days) of study treatment initiation (baseline)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Edwards, MD
Organizational Affiliation
University of Pittsburgh, Magee-Womens Hospital, Gynecologic Oncology Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer
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