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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma	Drug: RAD001; Drug: bevacizumab	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	September 2010
Actual Primary Completion Date :	January 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

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Arm	Intervention/treatment
Rad001/Bevacizumab; Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.	Drug: RAD001; 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.; Other Names: everolimus; derivative of rapamycin Drug: bevacizumab; bevacizumab will be administered intravenously (IV) once every 14 days.; Other Name: Avastin

Outcome Measures

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Primary Outcome Measures :

1. Progression-free Survival (PFS) at 6-months [ Time Frame: Up to 36 months (data collection period for the cohort); Up to 6 months for participant ]
   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 :

1. Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease) [ Time Frame: Within 4 weeks (28 days) of study treatment initiation (baseline) ]
   The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Novartis Pharmaceuticals

Genentech, Inc.

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Robert Edwards, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01031381 History of Changes
Other Study ID Numbers:	09-01-RAD001BEV
First Posted:	December 14, 2009
Results First Posted:	August 30, 2016
Last Update Posted:	August 30, 2016
Last Verified:	January 2016

Keywords provided by Robert Edwards, University of Pittsburgh:

Recurrent; ovarian; fallopian tube	primary peritoneal; cancer; Recurrent ovarian, fallopian tube, primary peritoneal cancer

Additional relevant MeSH terms:

Fallopian Tube Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Bevacizumab; Everolimus; Sirolimus; Angiogenesis Inhibitors	Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antifungal Agents