Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer (RADBEV)
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.
Fallopian Tube Cancer
Primary Peritoneal Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- To evaluate the progression-free survival at 6 months for RAD001 and bevacizumab in recurrent ovarian, peritoneal, and fallopian tube cancer [ Time Frame: 6 months to 1 year ] [ Designated as safety issue: Yes ]
- To evaluate the efficacy (complete response + partial response + stable disease) of RAD001 and bevacizumab in recurrent ovarian, peritoneal, and fallopian tube cancer [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Patients will recieve RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.
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:Drug: bevacizumab
bevacizumab will be administered intravenously (IV) once every 14 days.
Other Name: Avastin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031381
|Contact: Vicki Gilchrist, RNemail@example.com|
|Contact: Robert Edwards, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Magee-Womens Hospital of UPMC||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Vicki Gilchrist, RN, BSN 412-641-6373 email@example.com|
|Contact: Kristin Zorn, MD 412-641-5468 firstname.lastname@example.org|
|Principal Investigator: Robert Edwards, MD|
|Sub-Investigator: Thomas Krivak, MD|
|Sub-Investigator: Kristin Zorn, MD|
|Sub-Investigator: Paniti Sukumvanich, MD|
|Sub-Investigator: Joseph Kelley, MD|
|Sub-Investigator: Alexander Olawaiye, MD|
|Sub-Investigator: John Comerci, MD|
|Principal Investigator:||Robert Edwards, MD||University of Pittsburgh, Magee-Womens Hospital, Gynecologic Oncology Division|