Status:
COMPLETED
Bevacizumab (Avastin) and RAD001(Everolimus)in the Treatment of Advanced Clear Cell Renal Carcinoma
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Genentech, Inc.
Novartis
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 p...
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00323739
Start Date
May 1 2006
End Date
March 1 2011
Last Update
July 26 2013
Active Locations (12)
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1
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
2
Gainsville Hematology Oncology Associates
Gainesville, Florida, United States, 32605
3
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
4
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804