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

Completed · Phase 2

Conditions studied: Kidney Cancer

In brief

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.

Key facts

Study ID

NCT00323739

Run by

SCRI Development Innovations, LLC

People needed

80

Starts

2006-05-01

Expected to finish

2011-03-01

Last updated by the study team

2013-07-26

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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