Clinical trial NCT00455975: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cancer
Kidney Cancer
Keywords: Kidney Cancer
Renal Cancer
Clear Cell Carcinoma
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-04-04
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression-free Survival
timeFrame: 18 months (expected)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 18 months
measure: Objective Response Rate
timeFrame: 18 months
measure: Overall Tolerability and Toxicity of High-dose Bevacizumab
timeFrame: 18 months
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Louisville
country: United States
facility: Consultants in Blood Disorders and Cancer
state: Kentucky
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Omaha
country: United States
facility: Methodist Cancer Center
state: Nebraska
city: Asheville
country: United States
facility: Cancer Care of Western North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Associates
state: Tennessee
city: Collierville
country: United States
facility: Family Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Newport News
country: United States
facility: Peninsula Cancer Institute
state: Virginia
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, M.D.
role: STUDY_CHAIR
References: