Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer (RADBEV)
This study is currently recruiting participants.
Verified March 2013 by University of Pittsburgh
Information provided by (Responsible Party):
Robert Edwards, University of Pittsburgh
First received: December 10, 2009
Last updated: March 13, 2013
Last verified: March 2013
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
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| 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.
- derivative of rapamycin
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031381
|Magee-Womens Hospital of UPMC
|Pittsburgh, Pennsylvania, United States, 15213 |
|Contact: Vicki Gilchrist, RN, BSN 412-641-6373 firstname.lastname@example.org |
|Contact: Kristin Zorn, MD 412-641-5468 email@example.com |
|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 |
University of Pittsburgh
||Robert Edwards, MD
||University of Pittsburgh, Magee-Womens Hospital, Gynecologic Oncology Division
No publications provided
||Robert Edwards, Principal Investigator, University of Pittsburgh
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 10, 2009
||March 13, 2013
||United States: Food and Drug Administration
Keywords provided by University of Pittsburgh:
Recurrent ovarian, fallopian tube, primary peritoneal cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 16, 2014
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Digestive System Neoplasms
Digestive System Diseases
Fallopian Tube Diseases
Physiological Effects of Drugs