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

Phase 2

Completed

• Conditions: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma
• Interventions: Drug: RAD001; Drug: bevacizumab

• Registration Number: NCT01031381
• Lead Sponsor: University of Pittsburgh

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2009-12-11
• Study First Posted: 2009-12-14
• Study Start: 2010-09
• Primary Completion: 2014-01
• Study Completion: 2014-12
• Status Verified: 2016-01
• Results First Submitted: 2016-01-31
• Results First Submitted QC: 2016-07-19
• Last Update Submitted: 2016-07-19
• Results First Posted: 2016-08-30
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rad001/Bevacizumab	RAD001	Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.
Rad001/Bevacizumab	bevacizumab	Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) at 6-months	Up to 36 months (data collection period for the cohort); Up to 6 months for participant	The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

Secondary Outcome Measures

Name	Time	Method
Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease)	Within 4 weeks (28 days) of study treatment initiation (baseline)	The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

Trial Locations

Locations (1)

Magee-Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States