High-dose Bevacizumab in Advanced Renal Carcinoma Patients

Phase II Trial of High-Dose Bevacizumab in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma

This trial will examine the effectiveness and the side effects of 2 higher dosing schedules of bevacizumab in patients that have advanced clear cell renal carcinoma.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer; Renal Cancer
• Intervention / Treatment: Drug: Bevacizumab

Detailed Description

Bevacizumab is considered a targeted drug. Targeted drugs act on specific receptors on a cell. Bevacizumab blocks receptors that help cancer cells develop blood supplies so that the cancer can grow. These specific receptors are found in greater numbers in kidney cancer. In that regard bevacizumab will be tested in 2 doses that are higher than non-kidney cancer treatments with bevacizumab.

One group of patients will receive bevacizumab at 15 mg per kg by vein every 2 weeks. A total of 75 patients will be treated with this dose.

If this dose is well tolerated a second group of patients will receive bevacizumab at 15mg per kg by vein weekly.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Consultants in Blood Disorders and Cancer
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Center for Cancer and Blood Disorders
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Methodist Cancer Center
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Cancer Care of Western North Carolina
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Oncology Hematology Associates
    • Collierville, Tennessee, United States, 38017
      • Family Cancer Center
    • Nashville, Tennessee, United States, 37023
      • Tennessee Oncology, PLLC
  • Virginia
    • Newport News, Virginia, United States, 23601
      • Peninsula Cancer Institute

Participation Criteria

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
• Previous kidney removal is required except if the primary tumor was smaller than 5 cm or there was extensive liver or bone metastasis
• Patients may have received a maximum of 1 prior systemic treatment of immunotherapy (Interferon, IL-2), chemotherapy, or combination chemo+immunotherapy for metastatic disease.
• No prior bevacizumab
• Measurable disease
• Adequate liver and kidney function
• Age 18 and older

Exclusion Criteria:

• Acute MI within the past 6 months
• Uncontrolled high blood pressure or history of hypertensive crisis
• Clinically significant cardiovascular disease
• Active brain cancer
• Meningeal metastasis
• Pregnant or lactating women
• Prior treatment for another cancer less than 5 years ago
• No diseases of the central nervous system (eg. uncontrolled seizures, strokes or TIAs
• No bleeding from the mouth, rectum or coughing up blood or history of other bleeding or clotting disorders
• No history of deep vein thrombosis less than 12 months ago or are currently requiring full dose anticoagulation
• No major surgical procedures, open biopsies or traumatic injury in past 28 days
• No patients with peg tubes or feeding tubes
• No patients with non healing wounds, ulcers or long bone fractures
• No history of abdominal fistulas, gastrointestinal perforation or intrabdominal abscess within 6 months
• No symptomatic peripheral vascular disease

Please note: there are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weekly Avastin; Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity	Drug: Bevacizumab; Bevacizumab; Other Names: Avastin
Experimental: Bi-weekly Avastin; Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity	Drug: Bevacizumab; Bevacizumab; Other Names: Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival	Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions	18 months (expected)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Measured from date of study entry to date of death due to any cause.	18 months
Objective Response Rate	The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR	18 months
Overall Tolerability and Toxicity of High-dose Bevacizumab	Number of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities	18 months

Collaborators and Investigators

• Sponsor: SCRI Development Innovations, LLC
• Collaborators: Genentech, Inc.
• Investigators: Study Chair: John D. Hainsworth, M.D., SCRI Development Innovations, LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: April 3, 2007
• First Submitted That Met QC Criteria: April 3, 2007
• First Posted (Estimate): April 4, 2007

Study Record Updates

• Last Update Posted (Estimate): December 22, 2014
• Last Update Submitted That Met QC Criteria: December 12, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Kidney Cancer; Renal Cancer; Clear Cell Carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: SCRI GU 43; AVF 3913s