A Phase II Evaluation of Belinostat (NSC #726630, IND #729990) and Carboplatin (NSC #241240) in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
PRIMARY OBJECTIVES:
I. To estimate the antitumor activity of belinostat and carboplatin in patients with
persistent or recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal
cancer, measured by objective response rate and the frequency of progression- free survival
at 6 months.
II. To determine the nature and degree of toxicity of belinostat in combination with
carboplatin in this cohort of patients.
OUTLINE: This is a multicenter study.
Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60
minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of
disease progression or unacceptable toxicity. Patients who are clinically responding or who,
in the opinion of their physician, would continue to benefit from treatment may continue
treatment beyond 6 courses.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Frequency and duration of objective response
Up to 5 years
No
Don Dizon
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2010-01663
NCT00993616
December 2009
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Hurley Medical Center | Flint, Michigan 48503 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Akron General Medical Center | Akron, Ohio 44302 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Franklin Square Hospital Center | Baltimore, Maryland 21237 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
Beebe Medical Center | Lewes, Delaware 19958 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Research Medical Center | Kansas City, Missouri 64132 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Liberty Hospital | Liberty, Missouri 64068 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
Hillcrest Hospital Cancer Center | Mayfield Heights, Ohio 44124 |
M D Anderson Cancer Center | Houston, Texas 77030 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
Medical Oncology and Hematology Associates-West Des Moines | Clive, Iowa 50325 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Green Bay Oncology - Escanaba | Escanaba, Michigan 49431 |
Green Bay Oncology - Iron Mountain | Iron Mountain, Michigan 49801 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Saint Luke's Hospital of Kansas City | Kansas City, Missouri 64111 |
Saint Joseph Health Center | Kansas City, Missouri 64114 |
Truman Medical Center | Kansas City, Missouri 64108 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Green Bay Oncology at Saint Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Lyndon Baines Johnson General Hospital | Houston, Texas 77030 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
Lahey Clinic Medical Center | Burlington, Massachusetts 01805 |
Holy Family Memorial Hospital | Manitowoc, Wisconsin 54221 |
Carilion Clinic Gynecological Oncology | Roanoke, Virginia 24016 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Saint Luke's South Hospital | Overland Park, Kansas 66213 |
Heartland Hematology and Oncology Associates Incorporated | Kansas City, Missouri 64118 |
Saint Joseph Oncology Inc | Saint Joseph, Missouri 64507 |
University of Massachusetts Memorial Health Care | Worcester, Massachusetts 01605 |
Door County Cancer Center | Sturgeon Bay, Wisconsin 54235-1495 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland, Ohio 44111 |
Mercy Cancer Center-West Lakes | Clive, Iowa 50325 |
Mercy Medical Center-West Lakes | West Des Moines, Iowa 50266 |