Cisplatin and Etoposide With or Without Veliparib in Treating Patients With Extensive Stage Small Cell Lung Cancer
Extensive Stage Small Cell Lung Carcinoma, Large Cell Lung Carcinoma, Neuroendocrine Carcinoma
About this trial
This is an interventional treatment trial for Extensive Stage Small Cell Lung Carcinoma focused on measuring Veliparib, Small cell lung cancer
Eligibility Criteria
PHASE I
Inclusion Criteria (phase I):
- Women must not be pregnant or breastfeeding; breastfeeding must be discontinued or the subject is not eligible for the study
- All females of childbearing potential must have a blood test within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
Patients must have histologically or cytologically confirmed:
- Extensive stage small cell lung cancer (SCLC) or
- Stage IV (M1a or M1b according to American Joint Committee on Cancer [AJCC] Staging Manual, 7th edition) large cell neuroendocrine non-small cell lung cancer (NSCLC) or
Small cell carcinoma of unknown primary or extrapulmonary origin and must be a candidate for systemic therapy
- NOTE: The extensive disease SCLC classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy
- Patients must have measurable or non-measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; baseline measurements and evaluations of all sites of disease must be obtained =< 4 weeks prior to registration (Phase I)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Absolute neutrophil count >= 1,500/mm^3
- Platelets >= 100,000/mm^3
- Leukocytes >= 3,000/mm^3
- Hemoglobin >= 9 g/dL
- Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase[SGPT]) =< 3 times institutional ULN (=< 5 times if liver function test [LFT] elevations due to known liver metastases)
- Creatinine =< 1.5 X ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x ULN
- Patients with central nervous system (CNS) metastases or a history of CNS metastases are ineligible
- Patients cannot have had prior chemotherapy or biologic therapy for SCLC or large cell neuroendocrine NSCLC, or small cell carcinoma of unknown primary or extrapulmonary origin; patients receiving prior radiation cannot register within 7 days after completion of radiation, and must have resolved adverse events attributed to radiation to =< grade 1; no previous irradiation to the only site of measurable or evaluable disease, unless that site had subsequent evidence of progression
- Patients receiving prior radiation cannot register within 7 days after completion of radiation, and must have resolved adverse events attributed to radiation to =< grade 1; no previous irradiation to the only site of measurable or evaluable disease, unless that site had subsequent evidence of progression
- Patients must NOT have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
- Patient must be able to swallow pills
Exclusion Criteria (phase I):
- Patients have active seizure(s) or history of seizure(s)
- Patients have history of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib or other agents used in the study
PHASE II
Inclusion Criteria (phase II):
- Women must not be pregnant or breastfeeding; breastfeeding must be discontinued or the subject is not eligible for the study
- All females of childbearing potential must have a blood test within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) with the current month counted as month 1
- Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
- Patients must have extensive stage, histologically or cytologically confirmed small cell lung cancer; NOTE: the extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy
- Patients must have measurable disease based on RECIST 1.1; baseline measurements and evaluations of all sites of disease must be obtained =< 4 weeks prior to registration
- ECOG performance status 0 or 1
- Absolute neutrophil count >= 1,500/mm^3
- Platelets >= 100,000/mm^3
- Leukocytes >= 3,000/mm^3
- Hemoglobin >= 9 g/dL
- Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
- AST (SGOT) and ALT (SGPT) =< 3 times institutional ULN (=< 5 times if LFT elevations due to known liver metastases)
- Creatinine =< 1.5 X ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x ULN
- Patients cannot have had prior chemotherapy or biologic therapy for small cell lung cancer; patients receiving prior radiation cannot register within 7 days after completion of radiation, and must have resolved adverse events attributed to radiation to =< grade 1; no previous irradiation to the only site of measurable or evaluable disease, unless that site had subsequent evidence of progression
- Patient must be able to swallow pills
- Patients may not be receiving any other investigational agents while on study
Exclusion Criteria (phase II):
- Patients with CNS metastases or a history of CNS metastases are ineligible
- Patients have history of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib or other agents used in the study
- Patients have active seizure(s) or history of seizure(s)
- Patients must NOT have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with veliparib; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
Sites / Locations
- Loma Linda University Medical Center
- Stanford Cancer Institute Palo Alto
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- 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
- Colorado Cancer Research Program NCORP
- Mercy Medical Center
- Southwest Oncology PC
- Comprehensive Cancer Care and Research Institute of Colorado LLC
- Swedish Medical Center
- Mountain Blue Cancer Care Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- 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
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Smilow Cancer Hospital Care Center at Saint Francis
- Baptist MD Anderson Cancer Center
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- Dekalb Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Hawaii Oncology Inc-Pali Momi
- Pali Momi Medical Center
- The Cancer Center of Hawaii-Pali Momi
- Hawaii Cancer Care Inc-POB II
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Hawaii Oncology Inc-Kuakini
- The Cancer Center of Hawaii-Liliha
- Kapiolani Medical Center for Women and Children
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Kootenai Cancer Center
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- University of Chicago Comprehensive Cancer Center
- Carle on Vermilion
- Cancer Care Specialists of Central Illinois
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Illinois CancerCare-Galesburg
- NorthShore University HealthSystem-Glenbrook Hospital
- Ingalls Memorial Hospital
- Hematology Oncology Associates of Illinois-Highland Park
- NorthShore University HealthSystem-Highland Park Hospital
- Joliet Oncology-Hematology Associates Limited
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- NorthShore Hematology Oncology-Libertyville
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Trinity Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Health Center
- UC Comprehensive Cancer Center at Silver Cross
- Illinois Cancer Specialists-Niles
- Community Cancer Center Foundation
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Proctor Hospital
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois CancerCare-Princeton
- SwedishAmerican Regional Cancer Center/ACT
- Hematology Oncology Associates of Illinois - Skokie
- Memorial Medical Center
- Cancer Care Specialists of Illinois-Swansea
- Carle Cancer Center
- The Carle Foundation Hospital
- Rush-Copley Healthcare Center
- IU Health North Hospital
- Michiana Hematology Oncology PC-Crown Point
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Indiana University/Melvin and Bren Simon Cancer Center
- Sidney and Lois Eskenazi Hospital
- IU Health Central Indiana Cancer Centers-East
- Community Howard Regional Health
- IU Health La Porte Hospital
- Franciscan Saint Anthony Health-Michigan City
- Woodland Cancer Care Center
- Memorial Regional Cancer Center Day Road
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- Michiana Hematology Oncology PC-Plymouth
- Reid Health
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- Constantinou, Costas L MD (UIA Investigator)
- University of Iowa Healthcare Cancer Services Quad Cities
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Genesis Medical Center - East Campus
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Iowa Lutheran Hospital
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Methodist West Hospital
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas - Newton
- 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
- Cancer Center of Kansas - Wichita
- Via Christi Regional Medical Center
- Cancer Center of Kansas - Winfield
- Oncology Hematology Care Inc-Crestview
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Penobscot Bay Medical Center
- Sinai Hospital of Baltimore
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Boston Medical Center
- Baystate Medical Center
- University of Massachusetts Medical School
- Michigan Cancer Research Consortium NCORP
- Saint Joseph Mercy Hospital
- Beaumont Hospital-Dearborn
- Henry Ford Hospital
- Saint John Hospital and Medical Center
- Green Bay Oncology - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Saint Mary's of Michigan
- Saint John Macomb-Oakland Hospital
- Sanford Clinic North-Bemidgi
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Saint Luke's Hospital of Duluth
- Fairview-Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Unity Hospital
- Hutchinson Area Health Care
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- New Ulm Medical Center
- North Memorial Medical Health Center
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Saint Francis Medical Center
- Southeast Cancer Center
- Capital Region Southwest Campus
- Freeman Health System
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Saint Louis Cancer and Breast Institute-South City
- Missouri Baptist Medical Center
- Mercy Hospital Saint Louis
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Nebraska Hematology and Oncology
- Nebraska Cancer Research Center
- Southeast Nebraska Cancer Center
- Faith Regional Health Services Carson Cancer Center
- Great Plains Health Callahan Cancer Center
- Missouri Valley Cancer Consortium
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Nebraska Cancer Specialists - Omaha
- Alegent Health Lakeside Hospital
- Oncology Hematology West PC
- Urology Cancer Center PC
- Creighton University Medical Center
- Regional West Medical Center Cancer Center
- Dartmouth Hitchcock Medical Center
- Norris Cotton Cancer Center-Manchester
- Veterans Adminstration New Jersey Health Care System
- The Cancer Institute of New Jersey Hamilton
- Virtua Memorial
- Rutgers Cancer Institute of New Jersey
- Virtua Voorhees
- University of New Mexico Cancer Center
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- Dickstein Cancer Treatment Center
- Randolph Hospital
- Cone Health Cancer Center at Alamance Regional
- Southeastern Medical Oncology Center-Clinton
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Cone Health Cancer Center
- Hendersonville Hematology and Oncology at Pardee
- Margaret R Pardee Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Kinston Medical Specialists PA
- Cone Heath Cancer Center at Mebane
- FirstHealth of the Carolinas-Moore Regional Hospital
- Annie Penn Memorial Hospital
- Iredell Memorial Hospital
- Southeastern Medical Oncology Center-Wilson
- Sanford Bismarck Medical Center
- Roger Maris Cancer Center
- Sanford Broadway Medical Center
- Sanford Clinic North-Fargo
- Altru Cancer Center
- Summa Akron City Hospital/Cooper Cancer Center
- Strecker Cancer Center-Belpre
- Mercy Medical Center
- Adena Regional Medical Center
- Oncology Hematology Care Inc-Eden Park
- Oncology Hematology Care Inc-Mercy West
- Oncology Hematology Care Inc - Anderson
- Oncology Hematology Care Inc-Kenwood
- Oncology Hematology Care Inc-Blue Ash
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Samaritan North Health Center
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Oncology Hematology Care Inc-Healthplex
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Wayne Hospital
- Kettering Medical Center
- Fairfield Medical Center
- Lancaster Radiation Oncology
- Marietta Memorial Hospital
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Southern Ohio Medical Center
- Springfield Regional Medical Center
- Upper Valley Medical Center
- Saint Ann's Hospital
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Bryn Mawr Hospital
- Geisinger Medical Center
- Ephrata Community Hospital
- Adams Cancer Center
- Geisinger Medical Center-Cancer Center Hazleton
- Penn State Milton S Hershey Medical Center
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- Paoli Memorial Hospital
- University of Pennsylvania/Abramson Cancer Center
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Einstein Medical Center Philadelphia
- Geisinger Medical Oncology-Pottsville
- Penn State Health Saint Joseph Medical Center
- Guthrie Medical Group PC-Robert Packer Hospital
- Hematology and Oncology Associates of North East Pennsylvania
- Geisinger Medical Group
- Mount Nittany Medical Center
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- Lankenau Medical Center
- Main Line Health NCORP
- WellSpan Health-York Hospital
- Greenville Health System Cancer Institute-Easley
- McLeod Regional Medical Center
- Gibbs Cancer Center-Gaffney
- Greenville Health System Cancer Institute-Andrews
- Greenville Health System Cancer Institute-Butternut
- Greenville Health System Cancer Institute-Faris
- Greenville Memorial Hospital
- Greenville Health System Cancer Institute-Eastside
- Greenville Health System Cancer Institute-Greer
- Gibbs Cancer Center-Pelham
- Greenville Health System Cancer Institute-Seneca
- Spartanburg Medical Center
- Greenville Health System Cancer Institute-Spartanburg
- Sanford Cancer Center Oncology Clinic
- Sanford USD Medical Center - Sioux Falls
- Wellmont Bristol Regional Medical Center
- Wellmont Medical Associates Oncology and Hematology-Johnson City
- Wellmont Holston Valley Hospital and Medical Center
- Wellmont Medical Associates Oncology and Hematology-Kingsport
- Meharry Medical College
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont College of Medicine
- University of Virginia Cancer Center
- Sovah Health Martinsville
- Southwest VA Regional Cancer Center
- West Virginia University Healthcare
- Langlade Hospital and Cancer Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Sacred Heart Hospital
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- UW Cancer Center Johnson Creek
- Gundersen Lutheran Medical Center
- University of Wisconsin Hospital and Clinics
- Holy Family Memorial Hospital
- Bay Area Medical Center
- Marshfield Clinic
- Marshfield Medical Center
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- Cancer Center of Western Wisconsin
- ProHealth Oconomowoc Memorial Hospital
- Green Bay Oncology - Oconto Falls
- Ascension Saint Mary's Hospital
- Saint Mary's Hospital
- Lakeview Medical Center-Marshfield Clinic
- Marshfield Clinic-Rice Lake Center
- HSHS Saint Nicholas Hospital
- Ascension Saint Michael's Hospital
- Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- ProHealth Waukesha Memorial Hospital
- Aspirus Regional Cancer Center
- Marshfield Clinic-Wausau Center
- Diagnostic and Treatment Center
- Marshfield Clinic - Weston Center
- Saint Clare's Hospital
- Aspirus UW Cancer Center
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Cheyenne Regional Medical Center-West
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A (veliparib)
Arm B (placebo)
Patients receive veliparib PO BID on days 1-7, etoposide IV over 60-120 minutes on days 1-3, and cisplatin IV over 60-120 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients receive placebo PO BID on days 1-7, etoposide IV over 60-120 minutes on days 1-3, and cisplatin IV over 60-120 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.