Ziv-Aflibercept in Treating Patients With Metastatic or Unresectable Kidney Cancer

This study is currently recruiting participants.
Verified December 2013 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00357760
First received: July 26, 2006
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

This randomized phase II trial studies how well ziv-aflibercept works in treating patients with metastatic or unresectable kidney cancer. Ziv-afliberceptmay stop the growth of kidney cancer by blocking blood flow to the tumor.


Condition Intervention Phase
Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Biological: ziv-aflibercept
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study to Determine the Effect of 2 Different Doses AVE0005 (VEGF Trap) in Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free survival rate as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Time from randomization to the earlier of documentation of progression or death, assessed at 8 weeks ] [ Designated as safety issue: No ]
    A two-stage design will be used within each arm.


Secondary Outcome Measures:
  • Response rate [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
    A true objective response rate of 10% would be of interest, whereas a true rate of 1% would not.

  • Toxicity as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30 days of the last dose of treatment ] [ Designated as safety issue: Yes ]
    All patients receiving treatment, regardless of eligibility, will be included in the assessment of toxicity. Assuming that all 60 patients per arm receive treatment, the maximum width of a 90% exact binomial confidence interval on the rate of severe toxicities will be no wider than 22.5%.

  • Response duration [ Time Frame: From the time that measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2007
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (angiogenesis therapy)
Patients receive a higher dose of VEGF Trap IV over 1 hour on day 1.
Biological: ziv-aflibercept
Given IV
Other Names:
  • aflibercept
  • vascular endothelial growth factor trap
  • VEGF Trap
  • Zaltrap
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm B (angiogenesis therapy)
Patients receive a lower dose of VEGF Trap IV over 1 hour on day 1.
Biological: ziv-aflibercept
Given IV
Other Names:
  • aflibercept
  • vascular endothelial growth factor trap
  • VEGF Trap
  • Zaltrap
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Compare the effect of two different doses of AVE0005 (vascular endothelial growth factor [VEGF] Trap) treatment on the progression-free proportion at 8 weeks in patients with metastatic renal cell carcinoma who had previous treatment with a tyrosine kinase inhibitor (TKI).

SECONDARY OBJECTIVES:

I. Determine the effect of AVE0005 (VEGF Trap) treatment on objective response rate in patients with metastatic renal cell carcinoma who have had previous TKI treatment.

II. Describe progression-free survival among patients who undergo dose escalation after progression on low-dose AVE0005 (VEGF Trap).

III. Evaluate the safety and tolerability of AVE0005 (VEGF Trap) in patients with metastatic renal cell carcinoma who have had previous treatment with a TKI.

IV. Determine the circulating levels of VEGF AVE0005 (VEGF-Trap) complex and correlate it with clinical activity.

V. Evaluate the modulation of specific angiogenesis-related protein expression by AVE0005 (VEGF Trap).

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior cytokine therapy (yes vs no) and Memorial Sloan Kettering Cancer Center (MSKCC) risk (low vs medium vs high). Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive a higher dose of VEGF Trap intervenously (IV) over 1 hour on day 1.

ARM B: Patients receive a lower dose of VEGF Trap IV over 1 hour on day 1.

In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients receiving treatment on arm I may crossover and receive treatment on arm II if disease progression is evident after 4 courses of treatment.

After completion of study treatment, patients are followed every 3 months for 3 years.

  Eligibility

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

Inclusion Criteria:

  • Patient must have histologically confirmed metastatic or unresectable renal cell carcinoma; disease must be conventional clear cell carcinoma or have a component of clear cell carcinoma
  • Patients with true papillary, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors and transitional cell carcinoma are NOT eligible
  • Patient must have measurable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria; baseline measurements must be performed =< 4 weeks prior to randomization; all sites of disease, both measurable and nonmeasurable, must be evaluated =< 4 weeks prior to randomization
  • Patient must have evidence of progressive disease following treatment with a tyrosine kinase inhibitor (TKI) as assessed by the site investigator on the basis of computed tomography (CT) scans and other appropriate clinical documentation
  • Patient must have received at least one prior treatment with a VEGF receptor tyrosine kinase inhibitor for at least 12 weeks; prior treatment with either temsirolimus or everolimus is allowed; prior immunotherapy is limited to cytokine therapy with interleukin 2 and interferon alpha only; no other prior immunotherapy is allowed; no prior treatment with bevacizumab is allowed
  • No prior cellular therapy, vaccine, hormonal or chemotherapy for renal cell carcinoma is allowed; prior therapy for other cancers is allowable if therapy ended at least 5 years prior to enrollment
  • Previous radiotherapy (RT) is permissible provided the measurable disease is outside the RT port; RT must be completed >= 3 weeks prior to randomization
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patient must have recovered from any toxic effects of prior radiotherapy or surgical procedures within 4 weeks prior to randomization
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamic pyruvate transaminase (SGPT)(alanine aminotransferase [ALT] =< 3 times upper limit of normal (ULN)
  • Total serum bilirubin =< 1.5 times ULN
  • Absolute neutrophil count (ANC) >= 1 x 10^9/L
  • Platelet count >= 100 x 10^9/L
  • Hemoglobin >= 8.0 g/dL
  • Serum calcium =< 12.0 mg/dL
  • Calculated creatinine clearance (CrCl) >= 60 mL/min, and either proteinuria =< 500 mg/24 hours or urine protein: creatinine ratio (UPCR) =< 1
  • International normalized ratio (INR) within normal limits (or =< 1.5 x ULN if on prophylactic anticoagulation) and activated partial thromboplastin time (aPTT) within normal limits
  • Patients must not have history of metastatic central nervous system (CNS) disease
  • Female patients MUST NOT be pregnant or breastfeeding; due to the unknown teratogenic properties of AVE0005 (AVE0005 (VEGF Trap), its use in pregnant or breastfeeding patients is INADVISABLE; for women of childbearing potential, a negative serum pregnancy test is required within 1 week prior to randomization
  • Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception while on this study, and for 6 months after the completion of the study; if a woman becomes pregnant while she is on this study or within 6 months after the last dose of protocol therapy, she must inform her treating physician immediately; if a man impregnates a woman while he is on this study or within 6 months after the last dose of protocol therapy, he must inform his treating physician immediately
  • Patients who have had basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ of the breast, or lobular carcinoma in situ of the breast within the past five years are eligible only if treated with curative intent

    • Patients with other malignancies are eligible only if they have been continuously disease-free for > 5 years prior to the time of randomization
  • Patient must not have any of the following conditions within 24 weeks prior to randomization:

    • Myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack
  • No prior pulmonary embolism, deep vein thrombosis, or other thromboembolic event
  • Patient must not have a history of uncontrolled or labile hypertension, with or without antihypertensive drug treatment, within 12 weeks prior to drug administration; this is defined as blood pressure > 150/100 mm Hg or systolic blood pressure > 180 mm Hg on at least 2 repeated determinations on separate days
  • Patient must not have known active infection, evidence of bleeding or intratumoral bleeding, or underlying bleeding disorder
  • Patient must not have a known history of hypersensitivity to any Trap agents or recombinant proteins
  • Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from this study because of possible pharmacokinetic interactions with AVE0005 (VEGF Trap)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357760

  Hide Study Locations
Locations
United States, Colorado
The Medical Center of Aurora Terminated
Aurora, Colorado, United States, 80012
Boulder Community Hospital Terminated
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare Terminated
Colorado Springs, Colorado, United States, 80907
Rose Medical Center Terminated
Denver, Colorado, United States, 80220
Exempla Saint Joseph Hospital Terminated
Denver, Colorado, United States, 80218
Colorado Cancer Research Program CCOP Terminated
Denver, Colorado, United States, 80224-2522
Saint Anthony Central Hospital Terminated
Denver, Colorado, United States, 80204
Presbyterian - Saint Lukes Medical Center - Health One Terminated
Denver, Colorado, United States, 80218
Porter Adventist Hospital Terminated
Denver, Colorado, United States, 80210
Swedish Medical Center Terminated
Englewood, Colorado, United States, 80110
Saint Mary's Hospital and Regional Medical Center Terminated
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center Terminated
Greeley, Colorado, United States, 80631
Littleton Adventist Hospital Terminated
Littleton, Colorado, United States, 80122
Sky Ridge Medical Center Terminated
Lone Tree, Colorado, United States, 80124
Longmont United Hospital Terminated
Longmont, Colorado, United States, 80501
McKee Medical Center Terminated
Loveland, Colorado, United States, 80539
Parker Adventist Hospital Terminated
Parker, Colorado, United States, 80138
Saint Mary Corwin Medical Center Terminated
Pueblo, Colorado, United States, 81004
North Suburban Medical Center Terminated
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center Terminated
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Manchester Memorial Hospital Recruiting
Manchester, Connecticut, United States, 06040
Contact: Michael A. Reale    860-533-4000      
Principal Investigator: Michael A. Reale         
Eastern Connecticut Hematology and Oncology Associates Recruiting
Norwich, Connecticut, United States, 06360
Contact: Dennis E. Slater    860-886-8362      
Principal Investigator: Dennis E. Slater         
United States, District of Columbia
Sibley Memorial Hospital Active, not recruiting
Washington, District of Columbia, United States, 20016
United States, Florida
University of Florida Active, not recruiting
Gainesville, Florida, United States, 32610
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Wayne B. Harris    404-778-1868      
Principal Investigator: Wayne B. Harris         
Saint Joseph's-Candler Health System Recruiting
Savannah, Georgia, United States, 31405
Contact: Ovidiu G. Negrea    912-350-8568      
Principal Investigator: Ovidiu G. Negrea         
United States, Idaho
Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
United States, Illinois
Rush - Copley Medical Center Recruiting
Aurora, Illinois, United States, 60504
Contact: Kendrith M. Rowland    800-446-5532      
Principal Investigator: Kendrith M. Rowland         
Saint Joseph Medical Center Recruiting
Bloomington, Illinois, United States, 61701
Contact: John W. Kugler    800-793-2262      
Principal Investigator: John W. Kugler         
Graham Hospital Association Active, not recruiting
Canton, Illinois, United States, 61520
Memorial Hospital Terminated
Carthage, Illinois, United States, 62321
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Eureka Hospital Active, not recruiting
Eureka, Illinois, United States, 61530
Galesburg Cottage Hospital Terminated
Galesburg, Illinois, United States, 61401
Medical and Surgical Specialists Recruiting
Galesburg, Illinois, United States, 61401
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Mason District Hospital Terminated
Havana, Illinois, United States, 62644
Hinsdale Hematology Oncology Associates Incorporated Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Elyse Schneiderman    630-654-1790    info@hhoaltd.com   
Principal Investigator: Elyse Schneiderman         
Joliet Oncology-Hematology Associates Limited Active, not recruiting
Joliet, Illinois, United States, 60435
Mcdonough District Hospital Terminated
Macomb, Illinois, United States, 61455
Community Cancer Center Foundation Recruiting
Normal, Illinois, United States, 61761
Contact: John W. Kugler    800-793-2262      
Principal Investigator: John W. Kugler         
Bromenn Regional Medical Center Active, not recruiting
Normal, Illinois, United States, 61761
Ottawa Regional Hospital and Healthcare Center Recruiting
Ottawa, Illinois, United States, 61350
Contact: John W. Kugler    800-793-2262      
Principal Investigator: John W. Kugler         
Pekin Hospital Active, not recruiting
Pekin, Illinois, United States, 61554
Pekin Cancer Treatment Center Recruiting
Pekin, Illinois, United States, 61554
Contact: John W. Kugler    800-793-2262      
Principal Investigator: John W. Kugler         
Proctor Hospital Recruiting
Peoria, Illinois, United States, 61614
Contact: John W. Kugler    800-793-2262      
Principal Investigator: John W. Kugler         
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61603
Contact: John W. Kugler    800-793-2262      
Principal Investigator: John W. Kugler         
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: John W. Kugler    800-793-2262      
Principal Investigator: John W. Kugler         
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: John W. Kugler    800-793-2262      
Principal Investigator: John W. Kugler         
Illinois Oncology Research Association CCOP Recruiting
Peoria, Illinois, United States, 61615
Contact: John W. Kugler    800-793-2262      
Principal Investigator: John W. Kugler         
Illinois Valley Hospital Terminated
Peru, Illinois, United States, 61354
Perry Memorial Hospital Terminated
Princeton, Illinois, United States, 61356
Swedish American Hospital Terminated
Rockford, Illinois, United States, 61104
Saint Margaret's Hospital Active, not recruiting
Spring Valley, Illinois, United States, 61362
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781-0001
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Carle Clinic-Urbana Main Withdrawn
Urbana, Illinois, United States, 61801
Carle Foundation - Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Kendrith M. Rowland    800-446-5532      
Principal Investigator: Kendrith M. Rowland         
United States, Indiana
Indiana University Medical Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Theodore F. Logan    317-274-2552      
Principal Investigator: Theodore F. Logan         
Wishard Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Theodore F. Logan    317-274-2552      
Principal Investigator: Theodore F. Logan         
Saint Anthony Memorial Health Center Recruiting
Michigan City, Indiana, United States, 46360
Contact: Kendrith M. Rowland    800-446-5532      
Principal Investigator: Kendrith M. Rowland         
United States, Iowa
McFarland Clinic Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph J. Merchant    515-239-2621      
Principal Investigator: Joseph J. Merchant         
Cedar Rapids Oncology Association Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Deborah W. Wilbur    319-363-2690      
Principal Investigator: Deborah W. Wilbur         
Oncology Associates at Mercy Medical Center Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Deborah W. Wilbur    319-363-2690      
Principal Investigator: Deborah W. Wilbur         
Mercy Hospital Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Deborah W. Wilbur    319-363-2690      
Principal Investigator: Deborah W. Wilbur         
Medical Oncology and Hematology Associates-West Des Moines Active, not recruiting
Clive, Iowa, United States, 50325
Medical Oncology and Hematology Associates-Des Moines Active, not recruiting
Des Moines, Iowa, United States, 50309
Iowa Lutheran Hospital Active, not recruiting
Des Moines, Iowa, United States, 50316
Mercy Medical Center - Des Moines Active, not recruiting
Des Moines, Iowa, United States, 50314
Iowa Oncology Research Association CCOP Active, not recruiting
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates Active, not recruiting
Des Moines, Iowa, United States, 50314
Iowa Methodist Medical Center Active, not recruiting
Des Moines, Iowa, United States, 50309
Mercy Medical Center - North Iowa Recruiting
Mason City, Iowa, United States, 50401
Contact: Arvind Y. Vemula    800-433-3883      
Principal Investigator: Arvind Y. Vemula         
Ottumwa Regional Health Center Active, not recruiting
Ottumwa, Iowa, United States, 52501
Siouxland Hematology Oncology Associates Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender    712-252-0088      
Principal Investigator: Donald B. Wender         
Saint Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender    712-252-0088      
Principal Investigator: Donald B. Wender         
Mercy Medical Center-Sioux City Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender    712-252-0088      
Principal Investigator: Donald B. Wender         
United States, Kansas
Cancer Center of Kansas - Chanute Recruiting
Chanute, Kansas, United States, 66720
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Dodge City Recruiting
Dodge City, Kansas, United States, 67801
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - El Dorado Recruiting
El Dorado, Kansas, United States, 67042
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Fort Scott Recruiting
Fort Scott, Kansas, United States, 66701
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Independence Recruiting
Independence, Kansas, United States, 67301
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Kingman Recruiting
Kingman, Kansas, United States, 67068
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Liberal Recruiting
Liberal, Kansas, United States, 67901
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - McPherson Recruiting
McPherson, Kansas, United States, 67460
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Newton Recruiting
Newton, Kansas, United States, 67114
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Parsons Recruiting
Parsons, Kansas, United States, 67357
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Pratt Recruiting
Pratt, Kansas, United States, 67124
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Salina Recruiting
Salina, Kansas, United States, 67401
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Associates In Womens Health Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Wichita Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Main Office Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Wichita CCOP Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
United States, Maryland
Johns Hopkins University Active, not recruiting
Baltimore, Maryland, United States, 21287-8936
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Michigan Cancer Research Consortium Community Clinical Oncology Program Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Oakwood Hospital Recruiting
Dearborn, Michigan, United States, 48124
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Genesys Regional Medical Center-West Flint Campus Recruiting
Flint, Michigan, United States, 48532
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48502
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Allegiance Health Recruiting
Jackson, Michigan, United States, 49201
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord    269-373-7458      
Principal Investigator: Raymond S. Lord         
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord    269-373-7458      
Principal Investigator: Raymond S. Lord         
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord    269-373-7458      
Principal Investigator: Raymond S. Lord         
Sparrow Hospital Recruiting
Lansing, Michigan, United States, 48912
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341-2985
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint Joseph Mercy Port Huron Recruiting
Port Huron, Michigan, United States, 48060
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint Mary's of Michigan Recruiting
Saginaw, Michigan, United States, 48601
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint John Macomb-Oakland Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
United States, Minnesota
Sanford Clinic North-Bemidgi Active, not recruiting
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Essentia Health Duluth Clinic CCOP Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel A. Nikcevich    888-203-7267      
Principal Investigator: Daniel A. Nikcevich         
Essentia Health Saint Mary's Medical Center Active, not recruiting
Duluth, Minnesota, United States, 55805
Miller-Dwan Hospital Active, not recruiting
Duluth, Minnesota, United States, 55805
Fairview-Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Lake Region Healthcare Corporation-Cancer Care Active, not recruiting
Fergus Falls, Minnesota, United States, 56537
Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Hutchinson Area Health Care Recruiting
Hutchinson, Minnesota, United States, 55350
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Minnesota Oncology Hematology PA-Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Saint John's Hospital - Healtheast Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Abbott-Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
New Ulm Medical Center Recruiting
New Ulm, Minnesota, United States, 56073
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
North Memorial Medical Health Center Recruiting
Robbinsdale, Minnesota, United States, 55422
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Park Nicollet Clinic - Saint Louis Park Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Metro-Minnesota CCOP Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Saint Francis Regional Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Lakeview Hospital Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Minnesota Oncology and Hematology PA-Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
United States, Nebraska
Lincoln Medical Education Foundation Cancer Resource Center Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Gamini S. Soori    800-253-4368      
Principal Investigator: Gamini S. Soori         
Alegent Health Immanuel Medical Center Recruiting
Omaha, Nebraska, United States, 68122
Contact: Gamini S. Soori    800-253-4368      
Principal Investigator: Gamini S. Soori         
Alegent Health Lakeside Hospital Recruiting
Omaha, Nebraska, United States, 68130
Contact: Gamini S. Soori    800-253-4368      
Principal Investigator: Gamini S. Soori         
Alegent Health Bergan Mercy Medical Center Recruiting
Omaha, Nebraska, United States, 68124
Contact: Gamini S. Soori    800-253-4368      
Principal Investigator: Gamini S. Soori         
Creighton University Medical Center Recruiting
Omaha, Nebraska, United States, 68131
Contact: Gamini S. Soori    800-253-4368      
Principal Investigator: Gamini S. Soori         
Missouri Valley Cancer Consortium CCOP Recruiting
Omaha, Nebraska, United States, 68106
Contact: Gamini S. Soori    800-253-4368      
Principal Investigator: Gamini S. Soori         
United States, Nevada
Nevada Cancer Institute-Summerlin Campus Recruiting
Las Vegas, Nevada, United States, 89135
Contact: Oscar B. Goodman    702-822-5136      
Principal Investigator: Oscar B. Goodman         
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton    702-731-8274      
Principal Investigator: John A. Ellerton         
United States, New Jersey
Veterans Adminstration New Jersey Health Care System Recruiting
East Orange, New Jersey, United States, 07018-1095
Contact: Basil S. Kasimis    800-475-2336    patricia.goyer@med.va.gov   
Principal Investigator: Basil S. Kasimis         
UMDNJ - New Jersey Medical School Recruiting
Newark, New Jersey, United States, 07103
Contact: Lillian F. Pliner    732-235-8675      
Principal Investigator: Lillian F. Pliner         
United States, New York
New York Oncology Hematology PC -Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Charles H. Weissman    518-489-3612 ext 1342    sharon.krause@usoncology.com   
Principal Investigator: Charles H. Weissman         
The North Division of Montefiore Medical Center Terminated
Bronx, New York, United States, 10466
Mary Imogene Bassett Hospital Recruiting
Cooperstown, New York, United States, 13326
Contact: Eric Bravin    607-547-6965    jennifer.victory@bassett.org   
Principal Investigator: Eric Bravin         
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Ilan Shapira    212-844-6286      
Principal Investigator: Ilan Shapira         
United States, North Dakota
Roger Maris Cancer Center Active, not recruiting
Fargo, North Dakota, United States, 58122
Sanford Clinic North-Fargo Terminated
Fargo, North Dakota, United States, 58122
Sanford Medical Center-Fargo Active, not recruiting
Fargo, North Dakota, United States, 58122
United States, Ohio
Summa Akron City Hospital Recruiting
Akron, Ohio, United States, 44304
Contact: Jennifer E. Payne    330-375-6101      
Principal Investigator: Jennifer E. Payne         
Mary Rutan Hospital Terminated
Bellefontaine, Ohio, United States, 43311
Strecker Cancer Center-Belpre Recruiting
Belpre, Ohio, United States, 45714
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Aultman Health Foundation Recruiting
Canton, Ohio, United States, 44710
Contact: Kisa E. Weeman    330-363-6891      
Principal Investigator: Kisa E. Weeman         
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 45601
Contact: John P. Kuebler    502-361-8496      
Principal Investigator: John P. Kuebler         
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Bruce J. Averbook    216-778-8526    kbauchens@metrohealth.org   
Principal Investigator: Bruce J. Averbook         
Columbus CCOP Recruiting
Columbus, Ohio, United States, 43215
Contact: John P. Kuebler    502-361-8496      
Principal Investigator: John P. Kuebler         
Grant Medical Center Recruiting
Columbus, Ohio, United States, 43215
Contact: John P. Kuebler    502-361-8496      
Principal Investigator: John P. Kuebler         
Mount Carmel Health Center West Recruiting
Columbus, Ohio, United States, 43222
Contact: John P. Kuebler    502-361-8496      
Principal Investigator: John P. Kuebler         
Doctors Hospital Recruiting
Columbus, Ohio, United States, 43228
Contact: John P. Kuebler    502-361-8496      
Principal Investigator: John P. Kuebler         
Columbus Oncology and Hematology Associates Inc Recruiting
Columbus, Ohio, United States, 43214
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: John P. Kuebler    502-361-8496      
Principal Investigator: John P. Kuebler         
Delaware Health Center-Grady Cancer Center Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Grady Memorial Hospital Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Fairfield Medical Center Recruiting
Lancaster, Ohio, United States, 43130
Contact: John P. Kuebler    502-361-8496      
Principal Investigator: John P. Kuebler         
Saint Rita's Medical Center Recruiting
Lima, Ohio, United States, 45801
Contact: Henry Gerad    419-226-9617      
Principal Investigator: Henry Gerad         
Marietta Memorial Hospital Recruiting
Marietta, Ohio, United States, 45750
Contact: John P. Kuebler    502-361-8496      
Principal Investigator: John P. Kuebler         
Knox Community Hospital Recruiting
Mount Vernon, Ohio, United States, 43050
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: John P. Kuebler    502-361-8496      
Principal Investigator: John P. Kuebler         
Southern Ohio Medical Center Recruiting
Portsmouth, Ohio, United States, 45662
Contact: John P. Kuebler    502-361-8496      
Principal Investigator: John P. Kuebler         
Springfield Regional Medical Center Recruiting
Springfield, Ohio, United States, 45505
Contact: John P. Kuebler    502-361-8496      
Principal Investigator: John P. Kuebler         
Trinity's Tony Teramana Cancer Center Recruiting
Steubenville, Ohio, United States, 43952
Contact: Leonard J. Appleman    412-647-8073      
Principal Investigator: Leonard J. Appleman         
Genesis HealthCare System Recruiting
Zanesville, Ohio, United States, 43701
Contact: John P. Kuebler    502-361-8496      
Principal Investigator: John P. Kuebler         
United States, Oklahoma
Natalie W Bryant Cancer Center Terminated
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Saint Luke's Hospital Active, not recruiting
Bethlehem, Pennsylvania, United States, 18015
Bryn Mawr Hospital Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Paul B. Gilman    484-476-2649    wellenbachj@mlhs.org   
Principal Investigator: Paul B. Gilman         
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822-2001
Contact: Rajiv Panikkar    570-271-5251      
Principal Investigator: Rajiv Panikkar         
Geisinger Medical Center-Cancer Center Hazelton Recruiting
Hazleton, Pennsylvania, United States, 18201
Contact: Rajiv Panikkar    570-271-5251      
Principal Investigator: Rajiv Panikkar         
Paoli Memorial Hospital Recruiting
Paoli, Pennsylvania, United States, 19301
Contact: Paul B. Gilman    484-476-2649    wellenbachj@mlhs.org   
Principal Investigator: Paul B. Gilman         
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Elizabeth R. Plimack    215-728-4790      
Principal Investigator: Elizabeth R. Plimack         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Leonard J. Appleman    412-647-8073      
Principal Investigator: Leonard J. Appleman         
Geisinger Medical Group Recruiting
State College, Pennsylvania, United States, 16801
Contact: Rajiv Panikkar    570-271-5251      
Principal Investigator: Rajiv Panikkar         
Geisinger Wyoming Valley Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Rajiv Panikkar    570-271-5251      
Principal Investigator: Rajiv Panikkar         
Lankenau Hospital Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Paul B. Gilman    484-476-2649    wellenbachj@mlhs.org   
Principal Investigator: Paul B. Gilman         
Mainline Health CCOP Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Paul B. Gilman    484-476-2649    wellenbachj@mlhs.org   
Principal Investigator: Paul B. Gilman         
United States, South Dakota
Avera Cancer Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Addison R. Tolentino    800-657-4377    Jan.Healy@avera.org   
Principal Investigator: Addison R. Tolentino         
Avera McKennan Hospital and University Health Center Terminated
Sioux Falls, South Dakota, United States, 57105
United States, Texas
Scott and White Memorial Hospital Terminated
Temple, Texas, United States, 76508
United States, West Virginia
West Virginia University Charleston Recruiting
Charleston, West Virginia, United States, 25304
Contact: Steven J. Jubelirer    304-388-9944      
Principal Investigator: Steven J. Jubelirer         
United States, Wisconsin
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Gerald K. Bayer    800-432-6049      
Principal Investigator: Gerald K. Bayer         
UW Cancer Center Johnson Creek Active, not recruiting
Johnson Creek, Wisconsin, United States, 53038
Gundersen Lutheran Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Kurt Oettel    608-775-2385    cancerctr@gundluth.org   
Principal Investigator: Kurt Oettel         
University of Wisconsin Hospital and Clinics Active, not recruiting
Madison, Wisconsin, United States, 53792
Dean Hematology and Oncology Clinic Recruiting
Madison, Wisconsin, United States, 53717
Contact: Amit Sanyal    608-410-2700      
Principal Investigator: Amit Sanyal         
Holy Family Memorial Hospital Recruiting
Manitowoc, Wisconsin, United States, 54221
Contact: Gerald K. Bayer    800-432-6049      
Principal Investigator: Gerald K. Bayer         
Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Gerald K. Bayer    800-432-6049      
Principal Investigator: Gerald K. Bayer         
Cancer Center of Western Wisconsin Recruiting
New Richmond, Wisconsin, United States, 54017
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Saint Nicholas Hospital Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Gerald K. Bayer    800-432-6049      
Principal Investigator: Gerald K. Bayer         
Peru
Instituto Nacional de Enfermedades Neoplasicas Active, not recruiting
Lima, Peru, Lima 34
Sponsors and Collaborators
Investigators
Principal Investigator: Roberto Pili Eastern Cooperative Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00357760     History of Changes
Other Study ID Numbers: NCI-2009-00559, NCI-2009-00559, ECOG-E4805, CDR0000489069, E4805, E4805, U10CA021115
Study First Received: July 26, 2006
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014