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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborators: Genentech, Inc.; Novartis
• Treatments: Bevacizumab; Everolimus; Sirolimus

Criteria

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