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

July 18, 2013 updated by: SCRI Development Innovations, LLC

Phase II Trial of Bevacizumab(Avastin) and RAD001(Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists
      • Gainesville, Florida, United States, 32605
        • Gainsville Hematology Oncology Associates
      • Jacksonville, Florida, United States, 32256
        • Integrated Community Oncology Network
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Wellstar Cancer Research
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Consultants in Blood Disorders and Cancer
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70806
        • Baton Rouge General Medical Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Grand Rapids Clinical Oncology Program
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Oncology Hematology Associates
      • Nashville, Tennessee, United States, 37023
        • Tennessee Oncology, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab and RAD001
Bevacizumab 10mg/kg, IV infusion, every 2 weeks RAD001 10 mg by mouth daily
Drug: bevacizumab
Bevacizumab 10mg/kg, IV infusion, every 2 weeks
Other Names:
  • Avastin
Drug: RAD001
RAD001 10 mg by mouth daily
Other Names:
  • Everolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCRI Development Innovations, LLC

Collaborators

Novartis
Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

May 5, 2006

First Submitted That Met QC Criteria

May 5, 2006

First Posted (Estimate)

May 9, 2006

Study Record Updates

Last Update Posted (Estimate)

July 26, 2013

Last Update Submitted That Met QC Criteria

July 18, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCRI GU 32

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Cancer

Clinical Trials on bevacizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe