Ziv-Aflibercept in Treating Patients With Metastatic or Unresectable Kidney Cancer
Metastatic Renal Cell Carcinoma
About this trial
This is an interventional treatment trial for Metastatic Renal Cell Carcinoma focused on measuring Metastatic Renal Cell Carcinoma, VEGF Trap
Eligibility Criteria
Inclusion Criteria: Histologically confirmed metastatic or unresectable renal cell carcinoma; disease must be conventional clear cell carcinoma or have a component of clear cell carcinoma Patient must have measurable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST); baseline measurements must be performed =< 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 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 Adequate organ function as defined in the protocol 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 Exclusion Criteria: True papillary, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors and transitional cell carcinoma are not eligible Prior immunotherapy other than cytokine therapy with interleukin 2 and interferon alpha Prior treatment with bevacizumab Prior cellular therapy, vaccine, hormonal or chemotherapy for renal cell carcinoma; prior therapy for other cancers is allowable if therapy ended at least 5 years prior to enrollment History of metastatic central nervous system (CNS) disease Pregnant or breastfeeding 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 within 24 weeks prior to randomization Prior pulmonary embolism, deep vein thrombosis, or other thromboembolic event 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 Active infection, evidence of bleeding or intratumoral bleeding, or underlying bleeding disorder History of hypersensitivity to any Trap agents or recombinant proteins Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy
Sites / Locations
- The Medical Center of Aurora
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Porter Adventist Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- SCL Health Saint Joseph Hospital
- Rose Medical Center
- Colorado Cancer Research Program NCORP
- Swedish Medical Center
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Saint Anthony Hospital
- Littleton Adventist Hospital
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical Center
- Parker Adventist Hospital
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- SCL Health Lutheran Medical Center
- Smilow Cancer Hospital Care Center at Saint Francis
- Manchester Memorial Hospital
- Eastern Connecticut Hematology and Oncology Associates
- Sibley Memorial Hospital
- University of Florida
- Emory University/Winship Cancer Institute
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Saint Alphonsus Cancer Care Center-Boise
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Graham Hospital Association
- Memorial Hospital
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Eureka Hospital
- Galesburg Cottage Hospital
- Illinois CancerCare-Galesburg Cottage Plaza Office
- Illinois CancerCare-Galesburg
- Mason District Hospital
- Hinsdale Hematology Oncology Associates Incorporated
- Joliet Oncology-Hematology Associates Limited
- Mcdonough District Hospital
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Ottawa Regional Hospital and Healthcare Center
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Pekin Hospital
- Methodist Medical Center of Illinois
- Proctor Hospital
- Illinois CancerCare-Peoria
- OSF Saint Francis Medical Center
- Illinois Valley Hospital
- Perry Memorial Hospital
- SwedishAmerican Regional Cancer Center/ACT
- Saint Margaret's Hospital
- Memorial Medical Center
- Carle Cancer Center
- Indiana University/Melvin and Bren Simon Cancer Center
- Sidney and Lois Eskenazi Hospital
- Franciscan Saint Anthony Health-Michigan City
- McFarland Clinic PC-William R Bliss Cancer Center
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- Mercy Medical Center - North Iowa
- Ottumwa Regional Health Center
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Wichita
- Via Christi Regional Medical Center
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium NCORP
- Beaumont Hospital-Dearborn
- Saint John Hospital and Medical Center
- Hurley Medical Center
- Genesys Hurley Cancer Institute
- Genesys Regional Medical Center-West Flint Campus
- Allegiance Health
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- Saint Mary's of Michigan
- Saint John Macomb-Oakland Hospital
- Sanford Clinic North-Bemidgi
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview-Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Unity Hospital
- Hutchinson Area Health Care
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- New Ulm Medical Center
- North Memorial Medical Health Center
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology and Hematology PA-Woodbury
- Nebraska Cancer Research Center
- Missouri Valley Cancer Consortium
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- Nevada Cancer Research Foundation CCOP
- Nevada Cancer Institute-Summerlin Campus
- Veterans Adminstration New Jersey Health Care System
- Rutgers New Jersey Medical School
- New York Oncology Hematology PC -Albany Medical Center
- Mary Imogene Bassett Hospital
- Beth Israel Medical Center
- Montefiore Medical Center-Wakefield Campus
- Roger Maris Cancer Center
- Sanford Clinic North-Fargo
- Sanford Medical Center-Fargo
- Summa Akron City Hospital/Cooper Cancer Center
- Mary Rutan Hospital
- Strecker Cancer Center-Belpre
- Aultman Health Foundation
- Adena Regional Medical Center
- MetroHealth Medical Center
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- Mount Carmel Health Center West
- Doctors Hospital
- Delaware Health Center-Grady Cancer Center
- Grady Memorial Hospital
- Fairfield Medical Center
- Saint Rita's Medical Center
- Marietta Memorial Hospital
- Knox Community Hospital
- Licking Memorial Hospital
- Southern Ohio Medical Center
- Springfield Regional Medical Center
- Trinity's Tony Teramana Cancer Center
- Genesis Healthcare System Cancer Care Center
- Natalie Warren Bryant Cancer Center at Saint Francis
- Saint Luke's University Hospital-Bethlehem Campus
- Bryn Mawr Hospital
- Geisinger Medical Center
- Geisinger Medical Center-Cancer Center Hazleton
- Paoli Memorial Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- University of Pittsburgh Cancer Institute (UPCI)
- Geisinger Medical Group
- Geisinger Wyoming Valley/Henry Cancer Center
- Lankenau Medical Center
- Main Line Health NCORP
- Avera Cancer Institute
- Avera McKennan Hospital and University Health Center
- Scott and White Memorial Hospital
- West Virginia University Charleston
- Saint Vincent Hospital
- UW Cancer Center Johnson Creek
- Gundersen Lutheran Medical Center
- Dean Hematology and Oncology Clinic
- University of Wisconsin Hospital and Clinics
- Holy Family Memorial Hospital
- Bay Area Medical Center
- Cancer Center of Western Wisconsin
- Saint Nicholas Hospital
- Instituto Nacional de Enfermedades Neoplasicas
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm A (higher dose of VEGF Trap)
Arm B (lower dose of VEGF Trap)
Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Patients receive a lower dose of ziv-aflibercept (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. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.