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Spots Global Cancer Trial Database for Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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Trial Identification

Brief Title: Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Official Title: A Phase II Evaluation of the Poly (ADP-Ribose) Polymerase (PARP)-1 and -2 Inhibitor Veliparib (ABT-888) (NSC#737664) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Who Carry a Germline BRCA1 or BRCA2 Mutation

Study ID: NCT01540565

Study Description

Brief Summary: This phase II trial studies how well veliparib works in treating patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back or does not respond to treatment. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description: PRIMARY OBJECTIVES: I. To estimate the proportion of patients who have objective tumor response (complete or partial). II. To determine the frequency and severity of adverse events associated with treatment with veliparib (ABT-888) as assessed by the Active Version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 SECONDARY OBJECTIVES: I. To determine the duration of progression-free survival (PFS) and overall survival (OS). II. To determine the proportion of patients who survive progression-free for at least 6 months. TERTIARY OBJECTIVES: I. To explore the association between single nucleotide polymorphisms (SNPs) in deoxyribonucleic acid (DNA) repair genes (e.g., breast cancer \[BRCA\]1, Fanconi) and clinical characteristics, response, and patient outcome (PFS and OS). OUTLINE: Patients receive veliparib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 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

Saint Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

John Muir Medical Center-Concord Campus, Concord, California, United States

UC San Diego Moores Cancer Center, La Jolla, California, United States

Gynecologic Oncology Associates-Newport Beach, Newport Beach, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States

Stanford Cancer Institute Palo Alto, Palo Alto, California, United States

UCSF Medical Center-Mount Zion, San Francisco, California, United States

Rocky Mountain Gynecologic Oncology PC, Englewood, Colorado, United States

The Hospital of Central Connecticut, New Britain, Connecticut, United States

Yale University, New Haven, Connecticut, United States

Beebe Medical Center, Lewes, Delaware, United States

Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States

Florida Hospital Orlando, Orlando, Florida, United States

Northside Hospital, Atlanta, Georgia, United States

Northeast Georgia Medical Center-Gainesville, Gainesville, Georgia, United States

University of Hawaii Cancer Center, Honolulu, Hawaii, United States

Northwestern University, Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Decatur Memorial Hospital, Decatur, Illinois, United States

Sudarshan K Sharma MD Limted-Gynecologic Oncology, Hinsdale, Illinois, United States

Loyola University Medical Center, Maywood, Illinois, United States

Memorial Medical Center, Springfield, Illinois, United States

Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States

McFarland Clinic PC - Ames, Ames, Iowa, United States

Iowa Methodist Medical Center, Des Moines, Iowa, United States

Iowa-Wide Oncology Research Coalition NCORP, Des Moines, Iowa, United States

Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States

Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, United States

Mercy Medical Center - Des Moines, Des Moines, Iowa, United States

Iowa Lutheran Hospital, Des Moines, Iowa, United States

Cancer Center of Kansas - Chanute, Chanute, Kansas, United States

Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States

Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States

Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States

Cancer Center of Kansas-Independence, Independence, Kansas, United States

Cancer Center of Kansas-Kingman, Kingman, Kansas, United States

Cancer Center of Kansas-Liberal, Liberal, Kansas, United States

Cancer Center of Kansas - Newton, Newton, Kansas, United States

Cancer Center of Kansas - Parsons, Parsons, Kansas, United States

Cancer Center of Kansas - Pratt, Pratt, Kansas, United States

Cancer Center of Kansas - Salina, Salina, Kansas, United States

Cancer Center of Kansas - Wellington, Wellington, Kansas, United States

Associates In Womens Health, Wichita, Kansas, United States

Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States

Cancer Center of Kansas - Wichita, Wichita, Kansas, United States

Via Christi Regional Medical Center, Wichita, Kansas, United States

Wichita NCI Community Oncology Research Program, Wichita, Kansas, United States

Cancer Center of Kansas - Winfield, Winfield, Kansas, United States

Norton Hospital Pavilion and Medical Campus, Louisville, Kentucky, United States

Maine Medical Center-Bramhall Campus, Portland, Maine, United States

Sinai Hospital of Baltimore, Baltimore, Maryland, United States

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

Union Hospital of Cecil County, Elkton, Maryland, United States

Henry Ford Hospital, Detroit, Michigan, United States

Fairview Ridges Hospital, Burnsville, Minnesota, United States

Mercy Hospital, Coon Rapids, Minnesota, United States

Fairview-Southdale Hospital, Edina, Minnesota, United States

Unity Hospital, Fridley, Minnesota, United States

Hutchinson Area Health Care, Hutchinson, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States

Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States

Hennepin County Medical Center, Minneapolis, Minnesota, United States

New Ulm Medical Center, New Ulm, Minnesota, United States

North Memorial Medical Health Center, Robbinsdale, Minnesota, United States

Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States

Regions Hospital, Saint Paul, Minnesota, United States

United Hospital, Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center, Shakopee, Minnesota, United States

Lakeview Hospital, Stillwater, Minnesota, United States

Ridgeview Medical Center, Waconia, Minnesota, United States

Rice Memorial Hospital, Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States

Washington University School of Medicine, Saint Louis, Missouri, 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

Nebraska Methodist Hospital, Omaha, Nebraska, United States

Women's Cancer Center of Nevada, Las Vegas, Nevada, United States

Cooper Hospital University Medical Center, Camden, New Jersey, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Hope Women's Cancer Centers-Asheville, Asheville, North Carolina, United States

Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States

Duke University Medical Center, Durham, North Carolina, United States

Rutherford Hospital, Rutherfordton, North Carolina, United States

Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, North Carolina, United States

Summa Akron City Hospital/Cooper Cancer Center, Akron, Ohio, United States

Case Western Reserve University, Cleveland, Ohio, United States

Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States

Cleveland Clinic Foundation, Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Riverside Methodist Hospital, Columbus, Ohio, United States

Hillcrest Hospital Cancer Center, Mayfield Heights, 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

Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States

Paoli Memorial Hospital, Paoli, Pennsylvania, United States

University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States

Pennsylvania Hospital, Philadelphia, Pennsylvania, United States

Lankenau Medical Center, Wynnewood, Pennsylvania, United States

Main Line Health NCORP, Wynnewood, Pennsylvania, United States

Women and Infants Hospital, Providence, Rhode Island, United States

AnMed Health Cancer Center, Anderson, South Carolina, United States

Saint Francis Hospital, Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Faris, Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Eastside, Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Seneca, Seneca, South Carolina, United States

Greenville Health System Cancer Institute-Spartanburg, Spartanburg, South Carolina, United States

Baylor All Saints Medical Center at Fort Worth, Fort Worth, Texas, United States

M D Anderson Cancer Center, Houston, Texas, United States

Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States

University of Vermont Medical Center, Burlington, Vermont, 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

Kaiser Permanente Washington, 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

Marshfield Clinic Cancer Center at Sacred Heart, Eau Claire, Wisconsin, United States

Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, United States

Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States

Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay, Wisconsin, United States

University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States

Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States

Bay Area Medical Center, Marinette, Wisconsin, United States

Marshfield Clinic, Marshfield, Wisconsin, United States

Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, United States

Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States

Ascension Saint Mary's Hospital, Rhinelander, Wisconsin, United States

Marshfield Clinic-Rice Lake Center, Rice Lake, Wisconsin, United States

Ascension Saint Michael's Hospital, Stevens Point, Wisconsin, United States

ProHealth Waukesha Memorial Hospital, Waukesha, Wisconsin, United States

Aurora West Allis Medical Center, West Allis, Wisconsin, United States

Marshfield Clinic - Weston Center, Weston, Wisconsin, United States

Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, United States

Contact Details

Name: Robert Coleman

Affiliation: NRG Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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