Everolimus With or Without Bevacizumab in Treating Patients With Advanced Kidney Cancer That Progressed After First-Line Therapy

Stopped early · Phase 3

Conditions studied: Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v7, Stage IV Renal Cell Cancer AJCC v7

In brief

This randomized phase III trial studies giving everolimus together with bevacizumab to see how well it works compared to everolimus alone in treating patients with advanced kidney cancer that progressed after first-line therapy. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can interfere with tumor growth by blocking the ability of tumor cells to grow and spread. Everolimus and bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor. It is not yet known whether giving everolimus together with bevacizumab is better than everolimus alone in treating patients with advanced kidney cancer that has progressed after first-line therapy.

Key facts

Study ID

NCT01198158

Run by

National Cancer Institute (NCI)

People needed

77

Starts

2010-09-15

Expected to finish

2017-12-16

Last updated by the study team

2019-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Renal cell carcinoma with some component of clear cell histology
• Metastatic or unresectable disease
• Must have been treated with at least 1 prior VEGFR tyrosine kinase inhibitor treatment and have progressed or have been intolerant to treatment
• No prior systemic therapy with a vascular endothelial growth factor (VEGF) binding agent (e.g., bevacizumab)
• No prior systemic therapy with any mechanistic target of rapamycin (mTOR) inhibitor (e.g., sirolimus, temsirolimus, everolimus)
• Prior cytokine therapy is allowed
• Any systemic therapy must be completed at least 4 weeks prior to registration
• >= 2 weeks since any prior radiation (including palliative)
• Patients must not have had a major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to study registration, and must have fully recovered from any such procedure
• The following are not considered to be major procedures: thoracentesis, paracentesis, port placement, laparoscopy, thoracoscopy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies and routine dental procedures
• Patients must have measurable disease by RECIST criteria; lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan
• No active brain metastases: patients with treated, stable brain metastases for at least three months are eligible as long as they meet the following criteria:
• Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 3 months, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or CT) (stable dose of anticonvulsants are allowed); treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear accelerator [LINAC], or equivalent) or a combination as deemed appropriate by the treating physician; patients with central nervous system (CNS) metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 are not eligible
• Baseline brain imaging (MRI/CT) is required
• No serious non-healing wound, ulcer, or bone fracture
• No arterial thrombotic events within 6 months of registration:
• Including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block), significant vascular disease (i.e., aortic aneurysm, history of aortic dissection), or any other arterial thrombotic event are ineligible
• Patients who have experienced a deep venous thrombosis or pulmonary embolus within the past 6 months must be on stable therapeutic anticoagulation to be enrolled to this study
• Patients receiving anti-platelet agents and prophylactic anticoagulation are eligible
• No inadequately controlled hypertension: (defined as a blood pressure of >= 160 mmHg systolic and/or >= 90 mmHg diastolic on medication), or any prior history of hypertensive crisis or hypertensive encephalopathy
• No known severe impairment of lung function, defined as >= grade 2 dyspnea or cough, or either:
• Requirement of supplemental oxygen, or
• In cases where pulmonary function or pulse oximetry tests have been obtained, forced expiratory volume of the lung in one second (FEV1) or forced vital capacity (FVC) are < 50% of predicted, or single breath diffusing capacity of the lung for carbon monoxide (DLCO) is < 35% of predicted or resting room oxygen saturation is less than 90%
• No active or severe liver disease (e.g. acute or chronic hepatitis, cirrhosis)
• No positive serology for anti-hemoglobin C (HBC) or anti-hepatitis C virus (HCV) antibodies; hepatitis B virus (HBV) seropositive patients (hepatitis B surface antigen [HBsAg] positive) are eligible if they are closely monitored for evidence of active HBV infection by HBV deoxryribonucleic acid (DNA) testing and agree to receive suppressive therapy with lamivudine or other HBV-suppressive therapy until at least 4 weeks after the last dose of everolimus

Where it is running

• Fowler Family Center for Cancer Care — Jonesboro, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente-Anaheim — Anaheim, California, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
• PCR Oncology — Arroyo Grande, California, United States
• Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States
• Kaiser Permanente-Bellflower — Bellflower, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Epic Care Partners in Cancer Care — Emeryville, California, United States
• Kaiser Permanente-Fontana — Fontana, California, United States
• Kaiser Permanente-Fremont — Fremont, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Kaiser Permanente-Fresno — Fresno, California, United States
• Kaiser Permanente - Harbor City — Harbor City, California, United States
• Kaiser Permanente-Irvine — Irvine, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Kaiser Permanente-Cadillac — Los Angeles, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• Memorial Medical Center — Modesto, California, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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