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Cisplatin and Etoposide With or Without Veliparib in Treating Patients With Extensive Stage Small Cell Lung Cancer or Metastatic Large Cell Neuroendocrine Non-Small Cell Lung Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase IBiomarker/Laboratory analysis, TreatmentActive18 and overNCINCI-2012-01985
U10CA021115, ECOG-E2511, CDR0000736704, E2511, NCT01642251

Trial Description

Summary

This randomized phase I/II trial studies the side effects and the best dose of veliparib given together with cisplatin and etoposide and to see how well it works in treating patients with extensive stage small cell lung cancer or metastatic large cell neuroendocrine non-small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine the recommended phase II dose (RP2D) of veliparib to use in combination with cisplatin and etoposide (CE). (Phase I) II. To determine whether the addition of ABT-888 (veliparib) to cisplatin etoposide (CE) results in improved progression free survival (PFS) over CE with placebo in the frontline therapy of newly diagnosed extensive stage small cell lung cancer. (Phase II)

SECONDARY OBJECTIVES:

I. To determine the overall survival (OS) associated with the combination of CE plus ABT-888. (Phase II) II. To assess the overall response rate (ORR) as well as complete response rate (CRR) associated with the combination of CE plus ABT-888. (Phase II) III. To determine the toxicity profile of the combination of ABT-888 and CE chemotherapy in this patient population. (Phase II) IV. To conduct exploratory correlative analysis of the impact of select biomarkers. (Phase II) V. To compare the overall toxicity profile and specifically the incidence and severity of chemotherapy-induced peripheral neuropathy with the addition of ABT-888 to CE. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of veliparib followed by a phase II, randomized, double-blind study.

Phase I: Patients receive veliparib orally (PO) twice daily (BID) on days 1-7, etoposide intravenously (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.

Phase II: Patients are randomized to 1 of 2 treatment arms.

ARM A: 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.

ARM B: 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.

After completion of study treatment, patients are followed up for 3 years.

Eligibility Criteria

Inclusion Criteria:

  • Women must not be pregnant or breastfeeding
  • 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 histologically or cytologically confirmed:
  • Extensive stage small cell lung cancer (SCLC) (Phase I and II)
  • 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, or bilateral or contralateral supraclavicular adenopathy
  • 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) (Phase I only)
  • Small cell carcinoma of unknown primary or extrapulmonary origin and must be a candidate for systemic therapy (Phase I only)
  • 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)
  • 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 (Phase II)
  • 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 glutamic 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 (Phase I and II) or large cell neuroendocrine NSCLC (Phase I only), or small cell carcinoma of unknown primary or extrapulmonary origin (Phase I only)
  • 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 may not be receiving any other investigational agents while on study
  • Patients must NOT have active seizure(s) or history of seizure(s)
  • Patients must NOT have history of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib or other agents used in the study
  • 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

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Taofeek OwonikokoPrincipal Investigator

Trial Sites

U.S.A.
California
  Stanford
 Stanford Cancer Center
 Heather A Wakelee Ph: 650-498-7061
  Email: ccto-office@stanford.edu
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Boulder
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers at the Pavilion
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Colorado Blood Cancer Institute
 Keren Sturtz Ph: 888-785-6789
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Denver Midtown
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Rose
 Keren Sturtz Ph: 888-785-6789
 Rose Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Joseph Hospital
 Keren Sturtz Ph: 888-785-6789
  Durango
 Mercy Medical Center
 Keren Sturtz Ph: 888-785-6789
  Englewood
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greenwood Village
 Breast Cancer Care Consultants
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 Rocky Mountain Cancer Centers-Lakewood
 Keren Sturtz Ph: 888-785-6789
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Rocky Mountain Cancer Centers - Lone Tree
 Keren Sturtz Ph: 888-785-6789
 Sky Ridge Medical Center
 Keren Sturtz Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Longmont
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
  Parker
 Parker Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Parker
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 Rocky Mountain Cancer Centers - Pueblo
 Keren Sturtz Ph: 888-785-6789
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Tareq Al Baghdadi Ph: 734-712-3456
Florida
  Jacksonville
 Baptist Cancer Institute - Jacksonville
 Troy Hancil Guthrie Ph: 904-202-7051
Georgia
  Atlanta
 Winship Cancer Institute of Emory University
 Taofeek K Owonikoko Ph: 404-778-1868
 Taofeek K Owonikoko Ph: 404-778-1868
  Savannah
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 Mark A. Taylor Ph: 912-350-8568
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Tareq Al Baghdadi Ph: 734-712-3456
Illinois
  Bloomington
 Illinois CancerCare - Bloomington
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 St. Joseph Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Canton
 Illinois CancerCare - Canton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Carthage
 Illinois CancerCare - Carthage
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Chicago
 John H. Stroger, Jr. Hospital of Cook County
 Thomas E. Lad Ph: 312-864-6000
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Eureka
 Illinois CancerCare - Eureka
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Evanston
 CCOP - Evanston
 Thomas Hensing Ph: 847-570-2109
  Galesburg
 Galesburg Clinic, PC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Medical and Surgical Specialists, LLC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Glenview
 Glenbrook Hospital
 Thomas Hensing Ph: 847-570-2109
  Harvey
 Ingalls Cancer Care Center at Ingalls Memorial Hospital
 Mark F. Kozloff Ph: 708-915-4673
  Email: clinicaltrials@ingalls.org
  Highland Park
 Highland Park Hospital
 Thomas Hensing Ph: 847-570-2109
  Joliet
 Joliet Oncology-Hematology Associates, Limited - West
 Kulumani M Sivarajan Ph: 815-730-3098
  Email: maureenc@jolietoncology.com
  Kewanee
 Illinois CancerCare - Kewanee Clinic
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Macomb
 Illinois CancerCare - Macomb
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Moline
 Garneau, Stewart C MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
 Porubcin, Michael MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
 Spector, David MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
 Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
 David M Spector Ph: 309-779-4200
  Monmouth
 Illinois CancerCare - Monmouth
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Normal
 Community Cancer Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Ottawa
 Community Hospital of Ottawa
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Illinois CancerCare - Ottawa
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Pekin
 Cancer Treatment Center at Pekin Hospital
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Illinois CancerCare - Pekin
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peoria
 CCOP - Illinois Oncology Research Association
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Illinois CancerCare - Peoria
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Methodist Medical Center of Illinois
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 OSF St. Francis Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peru
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Princeton
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Rockford
 Advanced Care and Treatment Medical Group, PC
 Harvey Eric Einhorn Ph: 779-696-9400
  Email: cancercare@swedishamerican.org
Indiana
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Lawrence H. Einhorn Ph: 317-274-2552
Iowa
  Bettendorf
 Constantinou, Costas L MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Bruce Wender Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Bruce Wender Ph: 712-252-0088
Maryland
  Baltimore
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Christine L Hann Ph: 410-955-8804
  Email: jhcccro@jhmi.edu
Massachusetts
  Boston
 Eastern Cooperative Oncology Group
 Taofeek K Owonikoko Ph: 404-778-5575
  Email: towonik@emory.edu
  Worcester
 UMASS Memorial Cancer Center - University Campus
 Vijay K Kasturi Ph: 508-856-3216
  Email: cancer.research@umassmed.edu
Michigan
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Tareq Al Baghdadi Ph: 734-712-3456
 Saint Joseph Mercy Cancer Center
 Tareq Al Baghdadi Ph: 734-712-3456
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Tareq Al Baghdadi Ph: 734-712-3456
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Tareq Al Baghdadi Ph: 734-712-3456
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Brian L Burnette Ph: 800-432-6049
  Flint
 Genesys Hurley Cancer Institute
 Tareq Al Baghdadi Ph: 734-712-3456
 Hurley Medical Center
 Tareq Al Baghdadi Ph: 734-712-3456
  Iron Mountain
 Green Bay Oncology - Iron Mountain
 Brian L Burnette Ph: 800-432-6049
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Tareq Al Baghdadi Ph: 734-712-3456
  Kalamazoo
 Borgess Medical Center
 Raymond Sterling Lord Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Sterling Lord Ph: 269-373-7458
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Lansing
 Sparrow Regional Cancer Center
 Tareq Al Baghdadi Ph: 734-712-3456
  Livonia
 St. Mary Mercy Hospital
 Tareq Al Baghdadi Ph: 734-712-3456
  Pontiac
 St. Joseph Mercy Oakland
 Tareq Al Baghdadi Ph: 734-712-3456
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Tareq Al Baghdadi Ph: 734-712-3456
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Tareq Al Baghdadi Ph: 734-712-3456
  Warren
 St. John Macomb Hospital
 Tareq Al Baghdadi Ph: 734-712-3456
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
Missouri
  Cape Girardeau
 Saint Francis Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
New Jersey
  East Orange
 Veterans Affairs Medical Center - East Orange
 Basil S. Kasimis Ph: 800-475-2336
  Email: patricia.goyer@med.va.gov
  Hamilton
 Cancer Institute of New Jersey at Hamilton
 Joseph Aisner Ph: 732-235-8675
  Mount Holly
 Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
 Michael S. Entmacher Ph: 888-847-8823
  New Brunswick
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Joseph Aisner Ph: 732-235-8675
North Dakota
  Bismarck
 Medcenter One Hospital Cancer Care Center
 Preston D. Steen Ph: 701-234-6161
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
 Preston D. Steen Ph: 701-234-6161
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Jennifer E Payne Ph: 330-375-6101
Pennsylvania
  Bryn Mawr
 Bryn Mawr Hospital
 Albert S DeNittis Ph: 866-225-5654
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Rajiv Panikkar Ph: 570-271-5251
  Hazleton
 Geisinger Hazleton Cancer Center
 Rajiv Panikkar Ph: 570-271-5251
  Hershey
 Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
 Chandra Prakash Belani Ph: 717-531-3779
  Email: CTO@hmc.psu.edu
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Albert S DeNittis Ph: 866-225-5654
  Philadelphia
 Abramson Cancer Center of the University of Pennsylvania
 Charu Aggarwal Ph: 800-474-9892
 Albert Einstein Cancer Center
 William J. Tester Ph: 215-456-3880
  Sayre
 Guthrie Cancer Center at Guthrie Clinic Sayre
 Bradley W Lash Ph: 800-836-0388
  State College
 Geisinger Medical Group - Scenery Park
 Rajiv Panikkar Ph: 570-271-5251
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Terrence P. Cescon Ph: 610-988-9323
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Rajiv Panikkar Ph: 570-271-5251
  Wynnewood
 CCOP - Main Line Health
 Albert S DeNittis Ph: 866-225-5654
 Lankenau Cancer Center at Lankenau Hospital
 Albert S DeNittis Ph: 866-225-5654
South Dakota
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A Mazurczak Ph: 605-328-1367
 Miroslaw A Mazurczak Ph: 605-328-1367
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 David E Gerber Ph: 214-648-7097
Virginia
  Charlottesville
 University of Virginia Cancer Center
 Thao P Dang Ph: 434-243-6143
West Virginia
  Morgantown
 Mary Babb Randolph Cancer Center at West Virginia University Hospitals
 Manish Monga Ph: 304-293-2745
  Email: sfilburn@hsc.wvu.edu
Wisconsin
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Brian L Burnette Ph: 800-432-6049
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Brian L Burnette Ph: 800-432-6049
 St. Mary's Hospital Medical Center - Green Bay
 Brian L Burnette Ph: 800-432-6049
 St. Vincent Hospital Regional Cancer Center
 Brian L Burnette Ph: 800-432-6049
  Johnson Creek
 UW Cancer Center Johnson Creek
 Anne M. Traynor Ph: 877-405-6866
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Anne M. Traynor Ph: 877-405-6866
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Brian L Burnette Ph: 800-432-6049
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Brian L Burnette Ph: 800-432-6049
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Timothy R Wassenaar Ph: 262-928-7878
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Brian L Burnette Ph: 800-432-6049
  Sheboygan
 Saint Nicholas Hospital
 Brian L Burnette Ph: 800-432-6049
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Brian L Burnette Ph: 800-432-6049
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Timothy R Wassenaar Ph: 262-928-7878

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01642251
ClinicalTrials.gov processed this data on April 06, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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