Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Negative and/or BRCA Mutation-Associated Breast Cancer With or Without Brain Metastases
Metastatic BRCA-Associated Breast Carcinoma, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain
About this trial
This is an interventional treatment trial for Metastatic BRCA-Associated Breast Carcinoma
Eligibility Criteria
Inclusion Criteria:
Patients must have metastatic and/or recurrent (distant or locoregionally recurrent) breast cancer and be HER2 non-over expressing per 2013 American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) HER testing guidelines (0 or 1+ by immunohistochemistry [IHC]; and/or HER2 ratio < 2.0 and HER2 copy number < 4 signals/cell by in-situ hybridization [ISH])
Local Regional Recurrence
- In the breast (after preserving therapy)
- In the chest wall (after mastectomy)
- In the ipsilateral/parasternal/infra-or supraclavicular lymph nodes
- In the skin of the chest wall (not breast)
- In the reconstructed breast
Patients must also meet at least one of the following criteria:
- Triple negative: histologically confirmed primary and/or metastatic site that is estrogen receptor (ER)-negative (=< 1%), progesterone receptor (PR)-negative (=< 1%), and HER2-negative
- BRCA mutation: previously confirmed deleterious breast cancer 1, early onset (BRCA1) or breast cancer 2, early onset (BRCA2) germline mutation or suspected deleterious BRCA1 or BRCA2 germline mutation if the classification being used is the 5-tier classification; documentation of germline test results are required
- Patients must have measurable or non-measurable disease; patients must have a chest/abdominal/pelvis computed tomography (CT) scan (or positron emission tomography [PET]/CT of diagnostic quality, conventional or spiral) prior to registration; if the patient is unable to undergo CT with IV contrast due to allergy or renal insufficiency, a non-contrast CT may be performed; all scans needed for assessment of measurable disease must be performed within 28 days prior to registration; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form
- Patients must be women or men ≥ 18 years of age
Patients must have adequate tissue available and must agree to have specimens submitted for germline BRCA deoxyribonucleic acid (DNA) sequencing and other correlative studies
- NOTE: Blood for BRCA mutation testing is to be collected and submitted after registration but before treatment
- Patients must have had =< 1 prior cytotoxic regimen for metastatic disease (unless enrolling in the Progressive Brain Metastases Cohort); note that endocrine and immunotherapies do not count as cytotoxic regimens
- Patients must have completed any prior radiation therapy and hormonal therapy at least 14 days prior to registration
- Patients may receive bisphosphonates or denosumab concurrently with study treatment; if started prior to registration, it must be started at least 7 days prior to registration
- Patients must have recovered to =< grade 2 following a significant adverse event or toxicity attributed to previous anti-cancer treatment except neurotoxicity which must be =< grade 1
- Patients must have a performance status of 0-2 by Zubrod criteria
- Absolute neutrophil count (ANC) of >= 1,500/mL (within 21 days prior to registration); patients must not have had a blood transfusion within 28 days prior to registration
- Hemoglobin >= 10 g/dL (within 21 days prior to registration); patients must not have had a blood transfusion within 28 days prior to registration
- Platelet count >= 100,000/ mL (within 21 days prior to registration); patients must not have had a blood transfusion within 28 days prior to registration
- Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL if due to Gilbert's syndrome or if liver metastases are present) (within 21 days prior to registration)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x institutional upper limit of normal (IULN) (or =< 5 x IULN if liver metastases are present) (within 21 days prior to registration)
- Patients must have adequate renal function with serum creatinine level =< IULN within 21 days prior to registration
- Patients must have serum chemistries (including potassium and magnesium) within 21 days prior to registration to obtain baseline values
- Patients must be able to swallow whole capsules
- Patients with a history of uncontrolled seizure disorder; including focal or generalized seizure may not have had a seizure within one year prior to registration
- Patients with known brain metastases must either meet the additional criteria and enroll as part of the Progressive Brain Metastases Cohort, or have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 14 days of stable neurologic function prior to registration; patients with previously incidentally discovered or asymptomatic brain metastasis(es) must receive surgical excision and/or radiation therapy prior to registration; patients with progressive brain metastases following prior treatment are not eligible for the Standard Cohort, but may be considered for the Progressive Brain Metastases Cohort
- Patients must have a complete history and physical examination within 28 days prior to registration
- Patients of childbearing potential must not be pregnant (negative pregnancy test) or nursing due to the possibility of harm to a fetus or nursing infant from this treatment regimen; men and women of reproductive potential must have agreed to use an effective contraceptive method for 6 months after completion of study treatment; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study had been entered in the system
Progressive Brain Metastases Cohort
- S1416 is one study with two cohorts; patients who have progressive brain metastases after surgical excision and/or intracranial radiation will be in the Progressive Brain Metastases Cohort and will require a baseline magnetic resonance imaging (MRI); patients with previously treated brain metastases, stable disease and stable neurologic function for 14 days prior to trial registration will be in the Standard Cohort and may obtain MRI of the brain at the physician's discretion; randomization and treatment is the same for both cohorts
In addition to all of the previous eligibility criteria, patients with progressive brain metastases who do not satisfy the conditions to enroll in the standard cohort (neurologic stability for 14 days following surgery and/or radiation therapy) must also meet the following criteria to enroll as part of the brain metastases cohort:
- Patients with progressive brain metastases must have a baseline brain MRI within 28 days prior to registration; brain metastases must be progressive and >= 10 mm in longest dimension on radiographic imaging AFTER prior intracranial radiation (IR) therapy (i.e., whole brain radiation therapy [WBRT], stereotactic radiosurgery [SRS], gamma knife [GK] or local equivalent); patients must not have evidence of diffuse leptomeningeal disease on brain MRI or by previously documented cerebrospinal fluid (CSF) cytology; discrete dural metastases are permitted; there must be no evidence of hemorrhage or impending herniation on baseline brain imaging; patients with contraindication to gadolinium-enhanced MRI imaging are not eligible
- Patients must be on a stable or decreasing dose of steroids for >= 7 days prior to registration
- If patient had an open brain biopsy, at least 28 days must have elapsed between biopsy and registration
- Patients enrolling in the Progressive Brain Metastases Cohort can have received up to 3 prior lines of cytotoxic chemotherapy for metastatic disease; note that for enrollment in the standard cohort, patients must have had =< 1 prior cytotoxic regimen for metastatic disease
Exclusion Criteria:
- Patients must not have received prior cisplatin or poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors; prior carboplatin in the adjuvant/neoadjuvant setting is allowed, if completed more than 12 months prior to study entry
- Patients must not have received any chemotherapy within 14 days prior to registration
- Patients must not have received any immunotherapy, biologic or any investigational drug within 28 days prior to registration; patients must not have received bevacizumab within 42 days prior to registration
- Patients must not have a clinically relevant hearing impairment >= grade 2
- Patients must not have treatment-related acute myeloid leukemia (AML) (t-AML)/myelodysplastic syndrome (MDS) or features suggestive of AML/MDS
- Patients must not have had prior allogeneic bone marrow transplant or double umbilical cord blood transplantation
- Patients must not have any incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) that would limit the patient's ability to participate in the protocol
- Patients must not have baseline peripheral neuropathy that exceeds grade 1
Sites / Locations
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Mercy Hospital Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- Kaiser Permanente-Anaheim
- Sutter Auburn Faith Hospital
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- AIS Cancer Center at San Joaquin Community Hospital
- Kaiser Permanente-Baldwin Park
- Kaiser Permanente-Bellflower
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Mercy San Juan Medical Center
- Eden Hospital Medical Center
- Sutter Davis Hospital
- Epic Care-Dublin
- Mercy Cancer Center - Elk Grove
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Kaiser Permanente-Fontana
- Palo Alto Medical Foundation-Fremont
- Kaiser Permanente - Harbor City
- Kaiser Permanente-Irvine
- Kaiser Permanente Los Angeles Medical Center
- Kaiser Permanente West Los Angeles
- Contra Costa Regional Medical Center
- Fremont - Rideout Cancer Center
- Mercy UC Davis Cancer Center
- Memorial Medical Center
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Sutter Cancer Research Consortium
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Kaiser Permanente-Ontario
- Saint Joseph Hospital - Orange
- Palo Alto Medical Foundation Health Care
- Kaiser Permanente - Panorama City
- Eisenhower Medical Center
- Kaiser Permanente-Riverside
- Mercy Cancer Center - Rocklin
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- Mercy Cancer Center - Sacramento
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-San Diego Mission
- Kaiser Permanente-San Diego Zion
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Marcos
- Palo Alto Medical Foundation-Santa Cruz
- Sutter Pacific Medical Foundation
- Palo Alto Medical Foundation-Sunnyvale
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Sutter Solano Medical Center/Cancer Center
- Epic Care Cyberknife Center
- Kaiser Permanente-Woodland Hills
- Woodland Memorial Hospital
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- UCHealth University of Colorado Hospital
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- UCHealth Memorial Hospital Central
- Memorial Hospital North
- Denver Health Medical Center
- National Jewish Health-Main Campus
- The Women's Imaging Center
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Mercy Medical Center
- Southwest Oncology PC
- Mountain Blue Cancer Care Center - Swedish
- Swedish Medical Center
- Poudre Valley Hospital
- Mountain Blue Cancer Care Center
- National Jewish Health-Western Hematology Oncology
- Saint Mary's Hospital and Regional Medical Center
- Grand Valley Oncology
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Good Samaritan Medical Center
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- National Jewish Health-Northern Hematology Oncology
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Danbury Hospital
- Greenwich Hospital
- Middlesex Hospital
- Beebe Medical Center
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- TidalHealth Nanticoke / Allen Cancer Center
- Christiana Care Health System-Wilmington Hospital
- Halifax Health Medical Center-Centers for Oncology
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
- Baptist MD Anderson Cancer Center
- Memorial Hospital West
- Cleveland Clinic-Weston
- University Cancer and Blood Center LLC
- Augusta University Medical Center
- Dekalb Medical Center
- Lewis Hall Singletary Oncology Center
- South Georgia Medical Center/Pearlman Cancer Center
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Health - Coeur d'Alene
- Walter Knox Memorial Hospital
- Saint Luke's Cancer Institute - Fruitland
- Idaho Urologic Institute-Meridian
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Saint Alphonsus Cancer Care Center-Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Kootenai Cancer Clinic
- Saint Luke's Cancer Institute - Twin Falls
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Mount Sinai Hospital Medical Center
- University of Chicago Comprehensive Cancer Center
- Weiss Memorial Hospital
- Carle at The Riverfront
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Ascension Alexian Brothers - Elk Grove Village
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- AMITA Health Cancer Institute and Outpatient Center
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Good Samaritan Regional Health Center
- UC Comprehensive Cancer Center at Silver Cross
- Cancer Care Center of O'Fallon
- University of Chicago Medicine-Orland Park
- Illinois CancerCare-Ottawa Clinic
- Radiation Oncology of Northern Illinois
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- West Suburban Medical Center
- SwedishAmerican Regional Cancer Center/ACT
- Genesis Cancer Center - Silvis
- Central Illinois Hematology Oncology Center
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Southwest Illinois Health Services LLP
- Carle Cancer Center
- The Carle Foundation Hospital
- Rush-Copley Healthcare Center
- Deaconess Clinic Downtown
- Indiana University/Melvin and Bren Simon Cancer Center
- Sidney and Lois Eskenazi Hospital
- Springmill Medical Center
- Franciscan Saint Anthony Health-Michigan City
- Woodland Cancer Care Center
- Memorial Regional Cancer Center Day Road
- Chancellor Center for Oncology
- Reid Health
- Memorial Hospital of South Bend
- Mary Greeley Medical Center
- McFarland Clinic - Ames
- McFarland Clinic - Boone
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Genesis Medical Center - East Campus
- Genesis Cancer Care Institute
- Iowa Cancer Specialists
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- McFarland Clinic - Trinity Cancer Center
- Trinity Regional Medical Center
- McFarland Clinic - Jefferson
- McFarland Clinic - Marshalltown
- Siouxland Regional Cancer Center
- MercyOne Waterloo Cancer Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Kansas Institute of Medicine Cancer and Blood Center
- Minimally Invasive Surgery Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Menorah Medical Center
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Cancer Center of Kansas - Winfield
- Flaget Memorial Hospital
- Baptist Health Corbin
- Commonwealth Cancer Center-Corbin
- Oncology Hematology Care Inc-Crestview
- Baptist Health Hardin
- Baptist Health Lexington
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- Saint Joseph London
- Jewish Hospital
- Baptist Health Louisville
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Baptist Health Madisonville/Merle Mahr Cancer Center
- Baptist Health Paducah
- Jewish Hospital Medical Center South
- Christus Saint Frances Cabrini Hospital
- Ochsner Health Center-Summa
- Medical Center of Baton Rouge
- Ochsner High Grove
- Ochsner Medical Center Kenner
- Ochsner LSU Health Monroe Medical Center
- Louisiana State University Health Science Center
- Ochsner Medical Center Jefferson
- LSU Health Sciences Center at Shreveport
- CHRISTUS Highland Medical Center
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Penobscot Bay Medical Center
- Greater Baltimore Medical Center
- Holy Cross Hospital
- Lahey Hospital and Medical Center
- Mercy Medical Center
- Winchester Hospital
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- Saint Joseph Mercy Brighton
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
- Henry Ford Cancer Institute-Downriver
- Saint Joseph Mercy Canton
- Trinity Health IHA Medical Group Hematology Oncology - Canton
- Caro Cancer Center
- Saint Joseph Mercy Chelsea
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
- Hematology Oncology Consultants-Clarkston
- Newland Medical Associates-Clarkston
- Henry Ford Macomb Hospital-Clinton Township
- Beaumont Hospital - Dearborn
- Henry Ford Medical Center-Fairlane
- Henry Ford Hospital
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Green Bay Oncology - Escanaba
- Beaumont Hospital - Farmington Hills
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Helen DeVos Children's Hospital at Spectrum Health
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Michigan Breast Specialists-Grosse Pointe Woods
- William Beaumont Hospital-Grosse Pointe
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- Monroe Cancer Center
- Toledo Clinic Cancer Centers-Monroe
- Trinity Health Muskegon Hospital
- Lakeland Hospital Niles
- Ascension Providence Hospitals - Novi
- Henry Ford Medical Center-Columbus
- 21st Century Oncology-Pontiac
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy Oakland
- Spectrum Health Reed City Hospital
- Great Lakes Cancer Management Specialists-Rochester Hills
- Michigan Cancer Specialists
- Oakland Colon Rectal Associates
- Cancer Care Associates PC
- Comprehensive Medical Center PLLC
- Hematology Oncology Consultants PC
- Oakland Medical Group
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Ascension Providence Hospitals - Southfield
- Bhadresh Nayak MD PC-Sterling Heights
- Premier Hematology Oncology Care
- Mitchell Folbe MD PC
- Ascension Saint Joseph Hospital
- Munson Medical Center
- Michigan Institute of Urology-Town Center
- Claudia BR Herke MD PC
- William Beaumont Hospital - Troy
- Hematology Oncology Consultants PC-Troy
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland Hospital
- Henry Ford West Bloomfield Hospital
- Saint Mary's Oncology/Hematology Associates of West Branch
- University of Michigan Health - West
- Huron Gastroenterology PC
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Cambridge Medical Center
- Mercy Hospital
- Essentia Health - Deer River Clinic
- Essentia Health Saint Mary's - Detroit Lakes Clinic
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Essentia Health - Fosston
- Unity Hospital
- Essentia Health Hibbing Clinic
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- Monticello Cancer Center
- New Ulm Medical Center
- Essentia Health - Park Rapids
- Fairview Northland Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Coborn Cancer Center at Saint Cloud Hospital
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Essentia Health Sandstone
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Sanford Thief River Falls Medical Center
- Essentia Health Virginia Clinic
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Sanford Cancer Center Worthington
- Fairview Lakes Medical Center
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
- Baptist Cancer Center-Grenada
- Gulfport Memorial Hospital
- Hattiesburg Clinic - Hematology/Oncology Clinic
- University of Mississippi Medical Center
- Baptist Memorial Hospital and Cancer Center-Union County
- Baptist Memorial Hospital and Cancer Center-Oxford
- Baptist Memorial Hospital and Cancer Center-Desoto
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Siteman Cancer Center at West County Hospital
- Centerpoint Medical Center LLC
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Saint Luke's Hospital of Kansas City
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Mercy Hospital South
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Mercy Hospital Washington
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Nebraska Medicine-Bellevue
- CHI Health Saint Francis
- Heartland Hematology and Oncology
- CHI Health Good Samaritan
- Saint Elizabeth Regional Medical Center
- Nebraska Medicine-Village Pointe
- Alegent Health Immanuel Medical Center
- Hematology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- University of Nebraska Medical Center
- Midlands Community Hospital
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Norris Cotton Cancer Center-Manchester
- Dartmouth Cancer Center - Nashua
- Cooper Hospital University Medical Center
- AtlantiCare Health Park-Cape May Court House
- AtlantiCare Surgery Center
- Newark Beth Israel Medical Center
- Overlook Hospital
- Holy Name Hospital
- MD Anderson Cancer Center at Cooper-Voorhees
- Lovelace Medical Center-Downtown
- Lovelace Medical Center-Saint Joseph Square
- University of New Mexico Cancer Center
- New Mexico Oncology Hematology Consultants
- Presbyterian Kaseman Hospital
- Memorial Medical Center - Las Cruces
- Presbyterian Rust Medical Center/Jorgensen Cancer Center
- Christus Saint Vincent Regional Cancer Center
- Roswell Park Cancer Institute
- NYU Winthrop Hospital
- State University of New York Upstate Medical University
- SUNY Upstate Medical Center-Community Campus
- Dickstein Cancer Treatment Center
- AdventHealth Infusion Center Asheville
- UNC Lineberger Comprehensive Cancer Center
- Southeastern Medical Oncology Center-Clinton
- AdventHealth Infusion Center Haywood
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Hendersonville Hematology and Oncology at Pardee
- Margaret R Pardee Memorial Hospital
- AdventHealth Hendersonville
- Onslow Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Vidant Oncology-Kenansville
- Vidant Oncology-Kinston
- FirstHealth of the Carolinas-Moore Regional Hospital
- Vidant Oncology-Richlands
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Sanford South University Medical Center
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Essentia Health - Jamestown Clinic
- Trinity Cancer Care Center
- Summa Health System - Akron Campus
- Cleveland Clinic Akron General
- Indu and Raj Soin Medical Center
- Strecker Cancer Center-Belpre
- Saint Elizabeth Boardman Hospital
- Cleveland Clinic Mercy Hospital
- Dayton Physicians LLC-Miami Valley South
- Miami Valley Hospital South
- Adena Regional Medical Center
- Oncology Hematology Care Inc-Eden Park
- Oncology Hematology Care Inc-Mercy West
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc-Anderson
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- Oncology Hematology Care Inc-Blue Ash
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Mount Carmel East Hospital
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Dublin Methodist Hospital
- Oncology Hematology Care Inc-Healthplex
- Armes Family Cancer Center
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-Atrium
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Cleveland Clinic Cancer Center Independence
- Greater Dayton Cancer Center
- First Dayton Cancer Care
- Kettering Medical Center
- Fairfield Medical Center
- Saint Rita's Medical Center
- OhioHealth Mansfield Hospital
- Cleveland Clinic Cancer Center Mansfield
- Marietta Memorial Hospital
- OhioHealth Marion General Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Hillcrest Hospital Cancer Center
- Dayton Physicians LLC-Signal Point
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Saint Charles Hospital
- Mercy Health Perrysburg Cancer Center
- Southern Ohio Medical Center
- North Coast Cancer Care
- Dayton Physicians LLC-Wilson
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- Trinity's Tony Teramana Cancer Center
- Cleveland Clinic Cancer Center Strongsville
- ProMedica Flower Hospital
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Dayton Physicians LLC - Troy
- Upper Valley Medical Center
- South Pointe Hospital
- Saint Joseph Warren Hospital
- University of Cincinnati Cancer Center-West Chester
- Saint Ann's Hospital
- Cleveland Clinic Wooster Family Health and Surgery Center
- Saint Elizabeth Youngstown Hospital
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Integris Southwest Medical Center
- Mercy Hospital Oklahoma City
- Integris Cancer Institute of Oklahoma
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Legacy Mount Hood Medical Center
- Providence Newberg Medical Center
- Saint Alphonsus Medical Center-Ontario
- Providence Willamette Falls Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Saint Charles Health System-Redmond
- Legacy Meridian Park Hospital
- Jefferson Abington Hospital
- Lehigh Valley Hospital-Cedar Crest
- UPMC-Heritage Valley Health System Beaver
- Lehigh Valley Hospital - Muhlenberg
- Crozer-Keystone Regional Cancer Center at Broomall
- Bryn Mawr Hospital
- Christiana Care Health System-Concord Health Center
- Geisinger Medical Center
- Doylestown Hospital
- UPMC Hillman Cancer Center Erie
- Crozer Regional Cancer Center at Brinton Lake
- UPMC Cancer Centers - Arnold Palmer Pavilion
- UPMC Pinnacle Harrisburg
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- Geisinger Medical Center-Cancer Center Hazleton
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- UPMC Cancer Center at UPMC McKeesport
- Riddle Memorial Hospital
- UPMC Hillman Cancer Center in Coraopolis
- Consultants in Medical Oncology and Hematology?Newtown Square
- Paoli Memorial Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- UPMC-Magee Womens Hospital
- UPMC-Presbyterian Hospital
- UPMC-Saint Margaret
- University of Pittsburgh Cancer Institute (UPCI)
- UPMC-Shadyside Hospital
- UPMC Jefferson Regional Radiation Oncology
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- Geisinger Cancer Services-Pottsville
- Guthrie Medical Group PC-Robert Packer Hospital
- Community Medical Center
- Geisinger Medical Oncology-Selinsgrove
- UPMC Cancer Center at UPMC Northwest
- Geisinger Medical Group
- UPMC Uniontown Hospital Radiation Oncology
- UPMC Washington Hospital Radiation Oncology
- Geisinger Wyoming Valley/Henry Cancer Center
- UPMC Susquehanna
- Lankenau Medical Center
- AnMed Health Cancer Center
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South Carolina
- Prisma Health Cancer Institute - Laurens
- Prisma Health Cancer Institute - Easley
- McLeod Regional Medical Center
- Saint Francis Hospital
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Saint Francis Cancer Center
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Prisma Health Cancer Institute - Seneca
- Sanford Cancer Center Oncology Clinic
- Sanford USD Medical Center - Sioux Falls
- Memorial Hospital
- Pulmonary Medicine Center of Chattanooga-Hixson
- Baptist Memorial Hospital and Cancer Center-Memphis
- Baptist Memorial Hospital for Women
- Family Cancer Center-Memphis
- Meharry Medical College
- Memorial GYN Plus
- The Don and Sybil Harrington Cancer Center
- Dell Seton Medical Center at The University of Texas
- Saint Joseph Regional Cancer Center
- Brooke Army Medical Center
- University of Texas Medical Branch
- UTMB Cancer Center at Victory Lakes
- Farmington Health Center
- Huntsman Cancer Institute/University of Utah
- South Jordan Health Center
- Norris Cotton Cancer Center-North
- Danville Regional Medical Center
- Providence Regional Cancer System-Aberdeen
- Cancer Care Center at Island Hospital
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Seattle Cancer Care Alliance at EvergreenHealth
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Skagit Regional Health Cancer Care Center
- Skagit Valley Hospital
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- FHCC South Lake Union
- Fred Hutchinson Cancer Research Center
- Kaiser Permanente Washington
- Swedish Medical Center-Cherry Hill
- Swedish Medical Center-First Hill
- University of Washington Medical Center - Montlake
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- MultiCare Deaconess Cancer and Blood Specialty Center - North
- Franciscan Research Center-Northwest Medical Plaza
- Northwest Medical Specialties PLLC
- PeaceHealth Southwest Medical Center
- Legacy Cancer Institute Medical Oncology and Day Treatment
- Legacy Salmon Creek Hospital
- Providence Saint Mary Regional Cancer Center
- Wenatchee Valley Hospital and Clinics
- Providence Regional Cancer System-Yelm
- West Virginia University Charleston Division
- Edwards Comprehensive Cancer Center
- Duluth Clinic Ashland
- Northwest Wisconsin Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- Marshfield Clinic-Chippewa Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Marshfield Medical Center-EC Cancer Center
- Mayo Clinic Health System-Eau Claire Clinic
- Aurora Health Center-Fond du Lac
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- Aurora Cancer Care-Kenosha South
- Gundersen Lutheran Medical Center
- Mayo Clinic Health System-Franciscan Healthcare
- Marshfield Clinic - Ladysmith Center
- Holy Family Memorial Hospital
- Aurora Bay Area Medical Group-Marinette
- Saint Vincent Hospital Cancer Center at Marinette
- Marshfield Medical Center-Marshfield
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- Cancer Center of Western Wisconsin
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Marshfield Medical Center-Rice Lake
- HSHS Saint Nicholas Hospital
- Vince Lombardi Cancer Clinic-Sheboygan
- Marshfield Medical Center-River Region at Stevens Point
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Marshfield Clinic-Wausau Center
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Marshfield Medical Center - Weston
- Marshfield Clinic - Wisconsin Rapids Center
- Cheyenne Regional Medical Center-West
- Big Horn Basin Cancer Center
- Billings Clinic-Cody
- Welch Cancer Center
- Advance Oncology Center
- Doctor's Cancer Center-Arecibo
- Cancer Center-Metro Medical Center Bayamon
- Hematologia Oncologia San Pablo
- HIMA San Pablo Oncologic Hospital
- Doctors Cancer Center
- Instituto Oncologia Moderna Ponce
- San Juan Community Oncology Group
- Primary Care Physician Group
- Centro Comprensivo de Cancer de UPR
- San Juan City Hospital
- Centro de Hematologia y Oncologia del Sur
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (cisplatin and placebo)
Arm II (cisplatin and veliparib)
Patients receive cisplatin IV over 1 hour on day 1 and placebo PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive cisplatin IV over 1 hour on day 1 and veliparib PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.