Upstate Active Clinical Trials Seeking Participants
Study title
Randomized Phase III Trial Comparing Everolimus Plus Placebo Versus Everolimus Plus Bevacizumab for Advanced Renal Cell Carcinoma Progressing After Treatment with Tyrosine Kinase Inhibitors
IRB number
CIRB126
What is the purpose of the study?
The purpose of this study is to compare the effects of a drug called everolimus alone with those of the combination of everolimus and a drug called bevacizumab for advanced kidney cancer to find out which is better. In this study, subjects will get either the combination of everolimus and a placebo or the combination of everolimus and bevacizumab.
Bevacizumab is an antibody that can block a protein called vascular endothelial growth factor (VEGF), and can slow the growth of new blood vessels in the tumor. Bevacizumab (also called Avastin?) has been approved by the Food and Drug Administration (FDA) for the treatment of advanced colon, lung, and breast cancers, and glioblastoma (a type of brain cancer). Bevacizumab is also approved for the treatment of advanced kidney cancer in combination with interferon. Bevacizumab use in combination with everolimus in this study of advanced kidney cancer should be considered experimental.
Everolimus (also called Afinitor?) is a drug that has been shown to stop the growth of cancer cells in some patients. Everolimus has been approved by the FDA for the treatment of advanced kidney cancer that has not responded to at least one prior treatment.
Who is eligible?
Stage IV, pathologically proven, metastatic renal carcinoma with clear cell component, failure of at least 1 prior VEGFR TKI therapy defined as progressive disease or treatment intolerance, Granulocytese 1500/?L, Platelet Count e 100,000/?L, Bilirubin d 1.5 x ULN, AST d 2.5 x ULN, Calc. Creatinine Clearance e 30 mL/min, Fasting serum glucose d 1.5 x ULN, Serum Cholesterol d 300 mg/dL, Trigylcerides d 200 mg/dL, UPC Ratio < 1 or urine protein d 1+, No prior systemic therapy with a VEGF binding agent, No prior systemic therapy with any 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, e 2 weeks since any prior radiation (including palliative), e 4 weeks since any major surgery and fully recovered, Measurable disease by RECIST criteria, No active brain metastases (effectively treated brain metastases are allowed), No serious non-healing wound, ulcer, or bone fracture; No arterial thrombotic events within 6 months of registration, Patients who have experienced a deep venous thrombosis or pulmonary embolus with the past 6 months must be on therapeutic anticoagulation, Patients receiving anti-platelet agents and prophylactic anticoagulation are eligible, Patients with history of hypertension must be well controlled (< 160/90), No known severe impairment of lung function, No active or severe liver disease (e.g. acute or chronic hepatitis, cirrhosis) and no evidence of hepatitis B
or C infections, No NYHA Class e 2 congestive heart failure, No active bleeding or chronic hemorrhagic diathesis or increased risk for bleeding, No history of abdominal fistula, GI perforation or intra-abdominal abscess within 6 months, No ongoing immunosuppressive therapy including chronic systemic treatment with corticosteroids (e10 mg/day prednisone equivalent), Available archival tissue for submission, Not pregnant or nursing, Age e18 years, ECOG performance status 0-2 or Karnofsky score e 60%
What is involved if I participate?
- How long is the study?
: Subjects will be asked to take the study treatment for as long as their kidney cancer is responding to, or is stabilized by the drugs and they do not have any severe side effects from the drugs. If the cancer worsens, study treatment will be stopped. If the cancer is not growing but subjects develop severe side effects from the drugs, their doctor may ask them to stop taking one or both study drugs. After subjects are finished taking both study drugs, they will be asked to visit the office for periodic checkups for at least 5? years after they started the study. - Is transportation provided or reimbursed?
No - Is parking provided or reimbursed?
No - What tests and procedures are involved?
Medical history and physical examination, Blood and urine tests, Hepatitis B and C tests (you may receive hepatitis B therapy to prevent reactivation from a sleeping state if you have evidence of prior hepatitis B infection), Pregnancy test if you are a woman of child bearing age, CT or MRI scans of the chest, abdomen and brain
Who is the doctor administering the study?
Teresa Gentile MD, PhD
Where will the study take place?
University Hospital, Hematology/Oncology Clinics in Oswego, Oneida and at Hill Medical Center.
Over what time period is the study scheduled to run?
11/2010-7/2013
Who can I contact for more information?
- Name: Michelle Klick
- Phone: 315-464-8271
- Email: klickm@upstate.edu
- Fax: 315-464-8291
If you are interested in this trial, please contact the study coordinator or investigator noted above.
