- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00601926
Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer
A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bevacizumab
15 mg/kg over 90 minutes
|
15 mg/kg over 90 minutes every 3 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma.
Time Frame: Up to 2 years
|
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.
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Up to 2 years
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Response Rate to Bevacizumab in This Population.
Time Frame: Up to 2 years
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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.
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Up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of Bevacizumab in This Population of Patients
Time Frame: Up to 2 years
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Grade 3 or higher toxicities according to CTCAE version 3.0
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Up to 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Monk, MD, Ohio State University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- OSU-06111
- NCI-2011-03160 (Registry Identifier: Clinical Trial Reporting Program (CTRP))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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