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Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT01031381•University of Pittsburgh

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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)
+5 more criteria

Locations (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

September 1, 2010

Primary Completion Date

January 1, 2014

Completion Date

December 1, 2014

Last Updated

August 30, 2016

Enrollment

ACTUAL participants

Conditions

Ovarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma

Interventions

RAD001

DRUG

bevacizumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 30, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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