Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00601926
• Other study ID #: OSU-06111
• Secondary ID: NCI-2011-03160
• Status: Terminated
• Phase: Phase 2
• First received: January 22, 2008
• Last updated: May 18, 2015
• Start date: February 2008
• Est. completion date: May 2013

Study information

• Verified date: May 2015
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 2013
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed papillary renal cell carcinoma (RCC)

• Unresectable and/or metastatic disease

• Measurable disease, defined as = 1 lesion that can be accurately measured in = 1 dimension and is = 10 mm by spiral CT scan

• No known CNS (central nervous system) disease

PATIENT CHARACTERISTICS:

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• bevacizumab
15 mg/kg over 90 minutes every 3 weeks

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Paul Monk	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma.	Progression was defined by using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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.	Up to 2 years	No
Primary	Response Rate to Bevacizumab in This Population.	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 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; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.	Up to 2 years	No
Secondary	Safety of Bevacizumab in This Population of Patients	Grade 3 or higher toxicities according to CTCAE version 3.0	Up to 2 years	Yes

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