A Phase II Study of an Oral VEGF Receptor Tyrosine Kinase Inhibitor (PTK787/ZK222584) (IND #66370, NSC #719335) in Myelodysplastic Syndrome (MDS)
OBJECTIVES:
Primary
- Determine the response rate, in terms of hematologic improvement and complete and
partial remission, in patients with primary or secondary (therapy-related)
myelodysplastic syndromes treated with vatalanib.
- Determine the time to transformation to acute myeloid leukemia (at least 20% blasts) or
death in patients treated with this drug.
Secondary
- Determine the safety of this drug in these patients.
- Determine the duration of response in patients treated with this drug.
- Determine the cytogenetic response rate in patients treated with this drug.
- Determine the overall and progression-free survival of patients treated with this drug.
- Determine the incidence of infections requiring antibiotics or hospitalization or
bleeding requiring red blood cell transfusions in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified* according to risk group (low
grade [refractory anemia with or without ringed sideroblasts, refractory anemia with excess
blasts-1, refractory cytopenia with multilineage dysplasia with or without ringed
sideroblasts, myelodysplastic syndromes-unclassified, or chronic myelomonocytic leukemia-1]
vs high grade [refractory anemia with excess blasts-2 or chronic myelomonocytic
leukemia-2]).
NOTE: *Stratification according to risk (low vs high) does not occur after 11/30/06.
Patients receive oral vatalanib once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity. Patients with a complete response
(CR) receive 6 additional courses after documentation of a CR.
Patients are followed periodically for up to 5 years from study entry.
PROJECTED ACCRUAL: Approximately 144 patients will be accrued for this study within 2.5
years.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hematologic Response rate
measured by International Standardized Response Criteria for myelodysplastic syndromes (MDS)
5 yrs
No
Pankaj Gupta, MD
Study Chair
Veterans Affairs Medical Center - Minneapolis
United States: Food and Drug Administration
CDR0000339810
NCT00072475
December 2003
December 2013
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
Evanston Northwestern Healthcare - Evanston Hospital | Evanston, Illinois 60201-1781 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Mount Sinai Medical Center | New York, New York 10029 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Rhode Island Hospital Comprehensive Cancer Center | Providence, Rhode Island 02903 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset, New York 11030 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
Fort Wayne Medical Oncology and Hematology | Fort Wayne, Indiana 46815 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Mountainview Medical | Berlin, Vermont 05602 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Cancer Care Associates - Mercy Campus | Oklahoma City, Oklahoma 73120 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Kinston Medical Specialists | Kinston, North Carolina 28501 |
Miriam Hospital | Providence, Rhode Island 02906 |
Center for Cancer Care at OSF Saint Anthony Medical Center | Rockford, Illinois 61108 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
Faxton Regional Cancer Center | Utica, New York 13502 |
Callahan Cancer Center at Great Plains Regional Medical Center | North Platte, Nebraska 69103 |
Central Maine Comprehensive Cancer Center at Central Maine Medical Center | Lewiston, Maine 04240 |