High-dose Bevacizumab in Advanced Renal Carcinoma Patients

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Renal Cancer

Kidney Cancer

Treatments

Drug: Bevacizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00455975

AVF 3913s

SCRI GU 43

Details and patient eligibility

About

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.

Full 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.

Enrollment

119 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.