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

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
Novartis
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00323739
First received: May 5, 2006
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Drug: bevacizumab
Drug: RAD001
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Bevacizumab(Avastin) and RAD001(Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: May 2006
Study Completion Date: March 2011
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Avastin
Drug: RAD001
RAD001 10 mg by mouth daily
Other Name: Everolimus

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323739

Locations
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Gainsville Hematology Oncology Associates
Gainesville, Florida, United States, 32605
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
United States, Georgia
Wellstar Cancer Research
Marietta, Georgia, United States, 30060
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, Louisiana
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70806
United States, Michigan
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
United States, Nebraska
Methodist Cancer Center
Omaha, Nebraska, United States, 68114
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
Novartis
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
Publications:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00323739     History of Changes
Other Study ID Numbers: SCRI GU 32
Study First Received: May 5, 2006
Results First Received: December 19, 2012
Last Updated: July 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by SCRI Development Innovations, LLC:
kidney cancer
bevacizumab

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Bevacizumab
Everolimus
Sirolimus
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014