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Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008
First Received: January 22, 2008   Last Updated: March 27, 2009   History of Changes
Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00601926
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Biological: bevacizumab
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
Official Title: A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of patients free of disease progression as defined by RECIST at 12 months of treatment [ Designated as safety issue: No ]

Estimated Enrollment: 41
Study Start Date: February 2008
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0-1
  • Life expectancy > 6 months
  • ANC ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL
  • Total bilirubin ≤ 2.0 mg/dL
  • AST and ALT < 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601926

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service     866-627-7616     osu@emergingmed.com    
Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Investigators
Principal Investigator: J. Paul Monk, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center ( J. Paul Monk, III )
Study ID Numbers: CDR0000581136, OSU-06111
Study First Received: January 22, 2008
Last Updated: March 27, 2009
ClinicalTrials.gov Identifier: NCT00601926     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
papillary renal cell carcinoma
stage III renal cell cancer
stage IV renal cell cancer

Study placed in the following topic categories:
Urinary Tract Neoplasm
Kidney Cancer
Chromophil Renal Cell Carcinoma
Urogenital Neoplasms
Bevacizumab
Urologic Neoplasms
Angiogenesis Inhibitors
Carcinoma
Renal Cancer
Papillary Renal Cell Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Urogenital Neoplasms
Bevacizumab
Urologic Neoplasms
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Growth Inhibitors
Angiogenesis Modulating Agents
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009