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

Ovarian Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031381
• Other study ID #: 09-01-RAD001BEV
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2009
• Last updated: April 14, 2015
• Start date: September 2010
• Est. completion date: May 2013

Study information

• Verified date: April 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Primary Peritoneal Carcinoma

Intervention

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.
• bevacizumab
bevacizumab will be administered intravenously (IV) once every 14 days.

Locations

Country	Name	City	State
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Genentech, Inc., Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the progression-free survival at 6 months for RAD001 and bevacizumab in recurrent ovarian, peritoneal, and fallopian tube cancer		6 months to 1 year	Yes
Secondary	To evaluate the efficacy (complete response + partial response + stable disease) of RAD001 and bevacizumab in recurrent ovarian, peritoneal, and fallopian tube cancer		1 year	Yes