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

NCT ID: NCT00323739

Last Updated: 2013-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2011-03-31

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 previously untreated with any anti-angiogenesis agent and patients who have previously received one prior regimen containing an anti-angiogenesis agent.

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) of treatment. Patients with objective tumor response or stable disease will continue treatment with bevacizumab adn RAD001 on the same schedule. Treatment will continue until disease progression occurs.

Conditions

Kidney Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab and RAD001

Bevacizumab 10mg/kg, IV infusion, every 2 weeks RAD001 10 mg by mouth daily

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: DRUG

Bevacizumab 10mg/kg, IV infusion, every 2 weeks

RAD001

Intervention Type: DRUG

RAD001 10 mg by mouth daily

Interventions

bevacizumab

Bevacizumab 10mg/kg, IV infusion, every 2 weeks

Intervention Type: DRUG

RAD001

RAD001 10 mg by mouth daily

Intervention Type: DRUG

Other Intervention Names

Avastin; Everolimus

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John D. Hainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Locations

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

Countries

United States

References

Hainsworth JD, Spigel DR, Burris HA 3rd, Waterhouse D, Clark BL, Whorf R. Phase II trial of bevacizumab and everolimus in patients with advanced renal cell carcinoma. J Clin Oncol. 2010 May 1;28(13):2131-6. doi: 10.1200/JCO.2009.26.3152. Epub 2010 Apr 5.

Reference Type: RESULT

PMID: 20368560 (View on PubMed)

Other Identifiers

SCRI GU 32

Identifier Type: -

Identifier Source: org_study_id