Bevacizumab (Avastin) and RAD001(Everolimus)in the Treatment of Advanced Clear Cell Renal Carcinoma

Phase 2

Completed

Conditions: Kidney Cancer

Interventions: Drug: bevacizumab
Drug: RAD001

Registration Number: NCT00323739

Lead Sponsor: SCRI Development Innovations, LLC

Brief Summary: This phase II trial will evaluate the combination of bevacizumab + RAD001 in patients with metastatic renal cell carcinoma. In this trial the investigators will evaluate this combination in patients previously untreated with any anti-angiogenesis agent and patients who have previously received one prior regimen containing an anti-angiogenesis agent.

Detailed Description: All eligible patients will receive:

* Bevacizumab 10mg/kg, IV infusion, every 2 weeks

* RAD001 10 mg by mouth daily

All patients will be evaluated for response after completing two courses (8 weeks) of treatment. Patients with objective tumor response or stable disease will continue treatment with bevacizumab adn RAD001 on the same schedule. Treatment will continue until disease progression occurs.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

Inclusion Criteria

Histologically documented metastatic or unresectable locally recurrent clear cell renal carcinoma.
In patients with mixed histologies, the clear cell component must comprise ≥ 75% of the cancer
Previous nephrectomy is required with the following exceptions:
Primary tumor < 5cm
Extensive liver ( > 30% of liver parenchyma)or
Multiple (> 5) bone metastases, making nephrectomy a clinically contraindicated procedure
Patients may have had a maximum of 1 previous systemic regimen for metastatic disease
Patients may not have received previous bevacizumab. However, patients who have received other agents with anti-angiogenic activity (eg. sorafenib, SU11248, AG-013736, PTK787, thalidomide) as part of first-line treatment are eligible
Patients may not have received previous treatment with m-TOR inhibitors.
ECOG performance status 0 or 1
Measurable disease
Adequate liver, kidney and bone marrow function
No previous systemic treatment or radiation therapy for at least 2 weeks prior to study entry
Patients must be able to understand the nature of this study and give written informed consent

Exclusion Criteria

Age < 18 years
Treatment with > 1 previous systemic regimen for metastatic renal carcinoma
History of acute myocardial infarction within 6 months
Clinically significant cardiovascular disease
History of stroke within 6 months
Patients with active brain metastases
Patients with meningeal metastases
Women who are pregnant or lactating
Patients who have been treated within 5 years for other invasive cancers
Patients with history or evidence by physical examination of CNS disease
Patients with clinical history of hemoptysis or hematemesis
Patients with history of deep vein thrombosis or thromboembolic disease requiring full dose anticoagulation
Patients with major surgical procedures, open biopsies, or significant traumatic injuries within 28 days or anticipated need for major surgical procedure during the course of the study
Patients with peg-tubes or G-tubes
Patients are ineligible if a fine needle aspiration biopsy has been performed within seven days
Patients with proteinuria
Patients with any non-healing wound, ulcer, or long-bone fracture
Patients with any history of a bleeding diathesis or coagulopathy
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
Patients who have received any other experimental drug within 28 days of starting treatment
History of any other severe and/or uncontrolled medical disease
History of HIV infection
Chronic treatment with steroids or other immunosuppressive agents
Patients with impaired GI function that compromises the ability to swallow or absorb RAD001
Patients who are unwilling or unable to comply with the protocol

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab and RAD001	RAD001	Bevacizumab 10mg/kg, IV infusion, every 2 weeks RAD001 10 mg by mouth daily
Bevacizumab and RAD001	bevacizumab	Bevacizumab 10mg/kg, IV infusion, every 2 weeks RAD001 10 mg by mouth daily

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease	18 months

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death	18 months

Trial Locations

Locations (12): Baton Rouge General Medical Center
🇺🇸
Baton Rouge, Louisiana, United States
Oncology Hematology Care
🇺🇸
Cincinnati, Ohio, United States
Wellstar Cancer Research
🇺🇸
Marietta, Georgia, United States
Gainsville Hematology Oncology Associates
🇺🇸
Gainesville, Florida, United States
Consultants in Blood Disorders and Cancer
🇺🇸
Louisville, Kentucky, United States
Integrated Community Oncology Network
🇺🇸
Jacksonville, Florida, United States
Florida Hospital Cancer Institute
🇺🇸
Orlando, Florida, United States
Methodist Cancer Center
🇺🇸
Omaha, Nebraska, United States
Florida Cancer Specialists
🇺🇸
Fort Myers, Florida, United States
Grand Rapids Clinical Oncology Program
🇺🇸
Grand Rapids, Michigan, United States
Tennessee Oncology, PLLC
🇺🇸
Nashville, Tennessee, United States
Chattanooga Oncology Hematology Associates
🇺🇸
Chattanooga, Tennessee, United States