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

NCT ID: NCT01031381

Last Updated: 2016-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-12-31

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.

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rad001/Bevacizumab

Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.

Group Type: OTHER

RAD001

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

bevacizumab

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

Intervention Type: DRUG

Other Intervention Names

everolimus; derivative of rapamycin; Avastin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Robert Edwards

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Edwards, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh, Magee-Womens Hospital, Gynecologic Oncology Division

Locations

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

09-01-RAD001BEV

Identifier Type: -

Identifier Source: org_study_id