A Phase II Evaluation of ABT-888 (IND# 77840, NCI Supplied Agent: ABT-888, NSC #737664), Topotecan (NSC #609699) and Filgrastim or Pegfilgrastim in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix
PRIMARY OBJECTIVES:
I. To estimate the antitumor activity (objective response rate by RECIST 1.1) of ABT-888
(veliparib) 10 mg administered orally twice a day on days 1 to 5 with topotecan (topotecan
hydrochloride) 0.6 mg/m^2 administered IV once daily on days 1 to 5 of each cycle in
patients with persistent or recurrent carcinoma of the cervix.
II. To determine the nature and degree of toxicity of ABT-888 and topotecan in patients with
persistent or recurrent carcinoma of the cervix.
SECONDARY OBJECTIVES:
I. To determine the duration of progression-free survival and overall survival.
TERTIARY OBJECTIVES:
I. To determine whether evidence of an interaction exists between study treatments and tumor
expression of poly(ADP-ribos)ylation of E2 protein, E6/E7 proteins, and p53R2 in relation to
progression-free and overall survival or metastasis. (Translational) II. To explore the
association between methylation of FanCF and BRCA in pre-treatment tumor samples and pre-
and post-treatment biopsy samples and response, progression-free and overall survival of
patients, and/or metastasis. (Translational)
OUTLINE:
Patients receive veliparib orally (PO) twice daily and topotecan hydrochloride intravenously
(IV) over 30 minutes once daily on days 1-5. Patients also receive, according to
institutional standard, filgrastim subcutaneously (SC) beginning on day 6, 7, or 8 and
continuing until hematopoietic recovery or pegfilgrastim SC on day 6, 7, or 8. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples may be collected periodically for translational studies.
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, by RECIST 1.1
Up to 5 years
No
Charles Kunos
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2011-02659
NCT01266447
February 2011
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Tacoma General Hospital | Tacoma, Washington 98405 |
Hurley Medical Center | Flint, Michigan 48503 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Waukesha Memorial Hospital | Waukesha, Wisconsin 53188 |
North Shore University Hospital | Manhasset, New York 11030 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Scott and White Memorial Hospital | Temple, Texas 76508 |
Group Health Cooperative | Seattle, Washington 98112 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Parkland Memorial Hospital | Dallas, Texas 75235 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
Pacific Gynecology Specialists | Seattle, Washington 98104 |
Memorial Medical Center | Springfield, Illinois 62781 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
University of Texas Southwestern Medical Center | Dallas, Texas |
Northwest Hospital | Seattle, Washington 98133 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Virginia Commonwealth University | Richmond, Virginia |
Florida Hospital | Orlando, Florida 32803 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
Harrison Medical Center | Bremerton, Washington 98310 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
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 |
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 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
Saint Joseph Medical Center | Tacoma, Washington 98405 |
Oconomowoc Memorial Hospital-ProHealth Care Inc | Oconomowoc, Wisconsin 53066-3896 |
University of California Medical Center At Irvine-Orange Campus | Orange, California 92868 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
State University of New York Downstate Medical Center | Brooklyn, New York 11203 |
Monter Cancer Center | Lake Success, New York 11042 |
Southwest Gynecologic Oncology Associates Inc | Albuquerque, New Mexico 87106 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Providence Regional Cancer Partnership | Everett, Washington 98201 |
Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale, Illinois 60521 |
University Medical Center Brackenridge | Austin, Texas 78701 |
PeaceHealth Medical Group PC | Bellingham, Washington 98226 |
Skagit Valley Hospital Regional Cancer Care Center | Mount Vernon, Washington 98274 |
Olympic Medical Cancer Care Center | Sequim, Washington 98384 |
Rockwood Cancer Treatment Center | Spokane, Washington 99204 |
Providence Saint Mary Regional Cancer Center | Walla Walla, Washington 99362 |
Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |
D N Greenwald Center | Mukwonago, Wisconsin 53149 |