Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

NCT ID: NCT00601926

Last Updated: 2015-06-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2013-05-31

Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying the side effects and how well bevacizumab works in treating patients with unresectable or metastatic kidney cancer.

Detailed Description

OBJECTIVES:

Primary

• To evaluate the progression-free survival when bevacizumab is administered to patients with unresectable and/or metastatic papillary renal cell carcinoma.
• To further evaluate the safety of bevacizumab in these patients.

Secondary

• To examine, in a preliminary manner, the response rate to bevacizumab in these patients.
• To collect and store blood and urine samples for future analysis.
• To evaluate overall survival when bevacizumab is administered to these patients.

OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.

Conditions

Kidney Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab

15 mg/kg over 90 minutes

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: BIOLOGICAL

15 mg/kg over 90 minutes every 3 weeks

Interventions

bevacizumab

15 mg/kg over 90 minutes every 3 weeks

Intervention Type: BIOLOGICAL

Other Intervention Names

Avastin

Eligibility Criteria

Inclusion Criteria

• ECOG (Eastern Cooperative Oncology Group) performance status 0-1
• Life expectancy > 6 months
• ANC (absolute neutrophil count) ≥ 1,000/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10.0 g/dL
• Total bilirubin ≤ 2.0 mg/dL
• AST (aspartate aminotransferase) and ALT (Alanine transaminase) < 3 times normal
• Creatinine clearance > 50 mg/mL
• Calcium < 12 mg/dL (when corrected for level of serum albumin)
• No known HIV infection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Exclusion Criteria

• Inadequately controlled hypertension (defined as systolic blood pressure [BP] > 150 mm Hg and/or diastolic BP > 100 mm Hg on antihypertensive medications)
• Prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association class II-IV congestive heart failure
• Myocardial infarction or unstable angina within the past 6 months
• Stroke or transient ischemic attack within the past 6 months
• Significant vascular disease (e.g., aortic aneurysm or aortic dissection)
• Symptomatic peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Significant traumatic injury within the past 28 days
• Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• Serious, non-healing wound, ulcer, or bone fracture
• Proteinuria at screening as demonstrated by either of the following:

• Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening
• Urine dipstick for proteinuria ≥ 2+ OR 24-hour urine protein > 1g
• Known hypersensitivity to any component of bevacizumab

PRIOR CONCURRENT THERAPY:

• No prior systemic treatment for metastatic papillary RCC
• At least 4 weeks since prior palliative radiotherapy of painful areas
• More than 28 days since prior major surgical procedure or open biopsy
• No concurrent major surgical procedure
• More than 7 days since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device
• Concurrent low-dose acetylsalicylic acid (≤ 325 mg/day) allowed in patients at high-risk for arterial thromboembolic disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Paul Monk

OTHER

Sponsor Role: lead

Responsible Party

Paul Monk

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paul Monk, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

Related Links

http://cancer.osu.edu

Jamesline

Other Identifiers

NCI-2011-03160

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-06111

Identifier Type: -

Identifier Source: org_study_id