Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

This study has been terminated.
(Poor patient accrual. Attempts to open at other sites unsuccessful.)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Paul Monk, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00601926
First received: January 22, 2008
Last updated: May 18, 2015
Last verified: May 2015
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Response Rate to Bevacizumab in This Population. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Safety of Bevacizumab in This Population of Patients [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Grade 3 or higher toxicities according to CTCAE version 3.0


Enrollment: 5
Study Start Date: February 2008
Study Completion Date: May 2013
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab
15 mg/kg over 90 minutes
Biological: bevacizumab
15 mg/kg over 90 minutes every 3 weeks
Other Name: Avastin

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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601926

Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Paul Monk
Genentech, Inc.
Investigators
Principal Investigator: Paul Monk, MD Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Paul Monk, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00601926     History of Changes
Other Study ID Numbers: OSU-06111, NCI-2011-03160
Study First Received: January 22, 2008
Results First Received: June 20, 2014
Last Updated: May 18, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University Comprehensive Cancer Center:
papillary renal cell carcinoma
stage III renal cell cancer
stage IV renal cell cancer

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

ClinicalTrials.gov processed this record on August 30, 2015