High-dose Bevacizumab in Advanced Renal Carcinoma Patients

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455975
• Other study ID #: SCRI GU 43
• Secondary ID: AVF 3913s
• Status: Completed
• Phase: Phase 2
• First received: April 3, 2007
• Last updated: December 12, 2014
• Start date: February 2007
• Est. completion date: September 2013

Study information

• Verified date: December 2014
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Renal Cancer

Intervention

Drug:
• Bevacizumab
Bevacizumab

Locations

Country	Name	City	State
United States	Cancer Care of Western North Carolina	Asheville	North Carolina
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Chattanooga Oncology Hematology Associates	Chattanooga	Tennessee
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Family Cancer Center	Collierville	Tennessee
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Consultants in Blood Disorders and Cancer	Louisville	Kentucky
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Peninsula Cancer Institute	Newport News	Virginia
United States	Methodist Cancer Center	Omaha	Nebraska
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Overall Survival (OS)	Measured from date of study entry to date of death due to any cause.	18 months	No
Secondary	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	No
Secondary	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	Yes