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High-dose Bevacizumab in Advanced Renal Carcinoma Patients

Primary Purpose

Renal Cancer, Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cancer focused on measuring Kidney Cancer, Renal Cancer, Clear Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Florida Cancer Specialists
  • Northeast Georgia Medical Center
  • Consultants in Blood Disorders and Cancer
  • Center for Cancer and Blood Disorders
  • Methodist Cancer Center
  • Cancer Care of Western North Carolina
  • Oncology Hematology Care
  • University of Pittsburgh Medical Center
  • Spartanburg Regional Medical Center
  • Chattanooga Oncology Hematology Associates
  • Family Cancer Center
  • Tennessee Oncology, PLLC
  • Peninsula Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Weekly Avastin

Bi-weekly Avastin

Arm Description

Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity

Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival (OS)
Measured from date of study entry to date of death due to any cause.
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
Overall Tolerability and Toxicity of High-dose Bevacizumab
Number of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities

Full Information

First Posted
April 3, 2007
Last Updated
December 12, 2014
Sponsor
SCRI Development Innovations, LLC
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00455975
Brief Title
High-dose Bevacizumab in Advanced Renal Carcinoma Patients
Official Title
Phase II Trial of High-Dose Bevacizumab in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cancer, Kidney Cancer
Keywords
Kidney Cancer, Renal Cancer, Clear Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weekly Avastin
Arm Type
Experimental
Arm Description
Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity
Arm Title
Bi-weekly Avastin
Arm Type
Experimental
Arm Description
Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
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
Time Frame
18 months (expected)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Measured from date of study entry to date of death due to any cause.
Time Frame
18 months
Title
Objective Response Rate
Description
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
Time Frame
18 months
Title
Overall Tolerability and Toxicity of High-dose Bevacizumab
Description
Number of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D. Hainsworth, M.D.
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Consultants in Blood Disorders and Cancer
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Methodist Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Cancer Care of Western North Carolina
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Chattanooga Oncology Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Family Cancer Center
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37023
Country
United States
Facility Name
Peninsula Cancer Institute
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States

12. IPD Sharing Statement

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High-dose Bevacizumab in Advanced Renal Carcinoma Patients

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