Spots Global Cancer Trial Database for Veliparib, Topotecan Hydrochloride, and Filgrastim or Pegfilgrastim in Treating Patients With Persistent or Recurrent Cervical Cancer
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Trial Identification
Brief Title: Veliparib, Topotecan Hydrochloride, and Filgrastim or Pegfilgrastim in Treating Patients With Persistent or Recurrent Cervical Cancer
Official Title: A Phase II Evaluation of ABT-888 (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
Study ID: NCT01266447
Study Description
Brief Summary: This phase II clinical trial is studying the how well veliparib, topotecan hydrochloride, and filgrastim or pegfilgrastim work in treating patients with persistent or recurrent cervical cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by blocking them from dividing. Giving veliparib with chemotherapy may kill more tumor cells. Filgrastim or pegfilgrastim may cause the body to make more blood cells and help it recover from the side effects of chemotherapy.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Florida Hospital Orlando, Orlando, Florida, United States
Memorial University Medical Center, Savannah, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology, Hinsdale, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium CCOP, Ann Arbor, Michigan, United States
Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Saint John Hospital and Medical Center, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Genesys Regional Medical Center, Grand Blanc, Michigan, United States
Allegiance Health, Jackson, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Sparrow Hospital, Lansing, Michigan, United States
Saint Mary Mercy Hospital, Livonia, Michigan, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan, United States
Saint Joseph Mercy Port Huron, Port Huron, Michigan, United States
Saint Mary's of Michigan, Saginaw, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Cancer Research for the Ozarks NCORP, Springfield, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
Southwest Gynecologic Oncology Associates Inc, Albuquerque, New Mexico, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
State University of New York Downstate Medical Center, Brooklyn, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
North Shore-LIJ Health System/Center for Advanced Medicine, New Hyde Park, New York, United States
Case Western Reserve University, Cleveland, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Lake University Ireland Cancer Center, Mentor, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
University Medical Center Brackenridge, Austin, Texas, United States
Parkland Memorial Hospital, Dallas, Texas, United States
Zale Lipshy University Hospital, Dallas, Texas, United States
Clements University Hospital, Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
Scott and White Memorial Hospital, Temple, Texas, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
PeaceHealth Medical Group PC, Bellingham, Washington, United States
Harrison HealthPartners Hematology and Oncology-Bremerton, Bremerton, Washington, United States
Harrison Medical Center, Bremerton, Washington, United States
Providence Regional Cancer Partnership, Everett, Washington, United States
Skagit Valley Hospital Regional Cancer Care Center, Mount Vernon, Washington, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo, Poulsbo, Washington, United States
Pacific Gynecology Specialists, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Group Health Cooperative-Seattle, Seattle, Washington, United States
Swedish Medical Center-First Hill, Seattle, Washington, United States
Northwest Hospital, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
Olympic Medical Cancer Care Center, Sequim, Washington, United States
Cancer Care Northwest - Spokane South, Spokane, Washington, United States
Rockwood Cancer Treatment Center-DHEC-Downtown, Spokane, Washington, United States
MultiCare Tacoma General Hospital, Tacoma, Washington, United States
Saint Joseph Medical Center, Tacoma, Washington, United States
Providence Saint Mary Regional Cancer Center, Walla Walla, Washington, United States
Wenatchee Valley Hospital and Clinics, Wenatchee, Washington, United States
D N Greenwald Center, Mukwonago, Wisconsin, United States
Oconomowoc Memorial Hospital-ProHealth Care Inc, Oconomowoc, Wisconsin, United States
Waukesha Memorial Hospital, Waukesha, Wisconsin, United States
Contact Details
Name: Charles Kunos
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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