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Brief Title: Veliparib With or Without Radiation Therapy, Carboplatin, and Paclitaxel in Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
Official Title: A Dose Finding Study Followed by Phase II Randomized, Placebo-Controlled Study of Veliparib (ABT-888) Added to Chemoradiotherapy With Carboplatin and Paclitaxel for Unresectable Stage III Non-small Cell Lung Cancer (NSCLC), (NCI Study Number 8811)
Study ID: NCT01386385
Brief Summary: This phase I/II partially randomized trial studies the side effects and best dose of veliparib when given together with radiation therapy, carboplatin, and paclitaxel and to see how well it works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether radiation therapy, carboplatin, and paclitaxel are more effective with or without veliparib in treating non-small cell lung cancer.
Detailed Description: PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) and the recommended phase II dose of ABT-888 (veliparib) when given concurrently with standard carboplatin/paclitaxel and radiotherapy in patients with unresectable stage III non-small cell lung cancer (NSCLC). (Phase I) II. To assess whether carboplatin/paclitaxel plus ABT-888 compared with carboplatin/paclitaxel plus placebo improves progression-free survival (PFS) in patients with unresectable stage III NSCLC. (Phase II) III. To compare overall survival (OS) in patients treated with carboplatin/paclitaxel and radiotherapy plus ABT-888 to those treated with carboplatin, paclitaxel and radiotherapy plus placebo. (Phase II) IV. To assess the response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate in the subset of patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. (Phase II) V. To assess the safety and toxicity profile of the regimen. (Phase II) SECONDARY OBJECTIVES: I. To collect tumor tissue from pretreatment biopsies (archival samples) for biomarker studies, including poly (ADP-ribose) polymerase 1 (PARP) activity by measuring the levels of poly-ADP-ribose, gamma-H2A histone family, member X (gamma-H2AX), and messenger ribonucleic acid (mRNA) expression levels of deoxyribonucleic acid (DNA) repair enzymes such as excision repair cross-complementing rodent repair deficiency, complementation group 1 (ERCC1)/x-ray repair complementing defective repair in Chinese hamster cells 1 (XRCC1). II. To collect blood samples for evaluation of gamma-H2AX (circulating tumor cells) and other relevant future studies. OUTLINE: This is a phase I, dose-escalation study of veliparib followed by a randomized phase II study. PHASE I: INDUCTION THERAPY: Patients undergo 3-dimensional conformal radiation therapy (3D-CRT) once daily (QD), 5 days a week, for 6 weeks. Patients also receive veliparib orally (PO) twice daily (BID) on days 1-43 and carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 1 hour on days 1, 8, 15, 22, 36, and 43 in the absence of disease progression or unacceptable toxicity. Patients without disease progression after completion of chemoradiotherapy undergo consolidation therapy. CONSOLIDATION THERAPY: Beginning within 4-6 weeks of chemotherapy and radiation therapy, patients receive veliparib PO BID on days 1-7 (course 1) and 22-28 (course 2) and carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1 and on day 22 of course 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo 3D-CRT and receive veliparib, carboplatin, and paclitaxel as in Phase I induction and consolidation therapy. ARM II: Patients undergo 3D-CRT as in arm I. Patients also receive placebo PO BID on days 1-43 and carboplatin and paclitaxel as in Phase I. Within 4-6 weeks after completion of chemotherapy and radiation therapy, patients receive placebo on days 1-7 and carboplatin and paclitaxel as in Phase I. After completion of study treatment, patients are followed up every 4 months for first 2 years and then every 6 months until 5 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
Alaska Women's Cancer Care, Anchorage, Alaska, United States
Anchorage Oncology Centre, Anchorage, Alaska, United States
Katmai Oncology Group, Anchorage, Alaska, United States
Providence Alaska Medical Center, Anchorage, Alaska, United States
Banner University Medical Center - Tucson, Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States
Tower Cancer Research Foundation, Beverly Hills, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States
City of Hope Corona, Corona, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Los Angeles General Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Mercy Cancer Center, Merced, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
Yale University, New Haven, Connecticut, United States
Pali Momi Medical Center, 'Aiea, Hawaii, United States
Queen's Cancer Center - Pearlridge, 'Aiea, Hawaii, United States
The Cancer Center of Hawaii-Pali Momi, 'Aiea, Hawaii, United States
Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I, Honolulu, Hawaii, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Honolulu, Hawaii, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha, Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini, Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue, Hawaii, United States
Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States
Kootenai Health - Coeur d'Alene, Coeur d'Alene, Idaho, United States
Saint Luke's Cancer Institute - Fruitland, Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian, Meridian, Idaho, United States
Saint Luke's Cancer Institute - Nampa, Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States
Kootenai Cancer Clinic, Sandpoint, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls, Twin Falls, Idaho, United States
Rush - Copley Medical Center, Aurora, Illinois, United States
OSF Saint Joseph Medical Center, Bloomington, Illinois, United States
Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
Illinois CancerCare-Canton, Canton, Illinois, United States
Memorial Hospital of Carbondale, Carbondale, Illinois, United States
SIH Cancer Institute, Carterville, Illinois, United States
Illinois CancerCare-Carthage, Carthage, Illinois, United States
Centralia Oncology Clinic, Centralia, Illinois, United States
Northwestern University, Chicago, Illinois, United States
Carle at The Riverfront, Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States
Carle Physician Group-Effingham, Effingham, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Illinois CancerCare-Eureka, Eureka, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center, Galesburg, Illinois, United States
Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States
Illinois CancerCare-Macomb, Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States
Cancer Care Center of O'Fallon, O'Fallon, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Illinois CancerCare-Pekin, Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin, Pekin, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF Saint Francis Medical Center, Peoria, Illinois, United States
Illinois CancerCare-Peru, Peru, Illinois, United States
Valley Radiation Oncology, Peru, Illinois, United States
Illinois CancerCare-Princeton, Princeton, Illinois, United States
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Springfield Clinic, Springfield, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Southwest Illinois Health Services LLP, Swansea, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
The Carle Foundation Hospital, Urbana, Illinois, United States
Rush-Copley Healthcare Center, Yorkville, Illinois, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States
Reid Health, Richmond, Indiana, United States
McFarland Clinic - Ames, Ames, Iowa, United States
Siouxland Regional Cancer Center, Sioux City, 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
Saint Catherine Hospital, Garden City, Kansas, United States
Central Care Cancer Center - Great Bend, Great Bend, Kansas, United States
HaysMed, Hays, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
University of Kansas Cancer Center-West, Kansas City, Kansas, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
Cancer Center of Kansas-Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal, Liberal, Kansas, United States
Cancer Center of Kansas-Manhattan, Manhattan, Kansas, United States
Cancer Center of Kansas - McPherson, McPherson, Kansas, United States
Cancer Center of Kansas - Newton, Newton, Kansas, United States
Olathe Health Cancer Center, Olathe, Kansas, United States
University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States
Cancer Center of Kansas - Parsons, Parsons, Kansas, United States
Ascension Via Christi - Pittsburg, Pittsburg, Kansas, United States
Cancer Center of Kansas - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas - Salina, Salina, Kansas, United States
Salina Regional Health Center, Salina, Kansas, United States
University of Kansas Health System Saint Francis Campus, Topeka, Kansas, United States
Cancer Center of Kansas - Wellington, Wellington, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States
Associates In Womens Health, Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States
Ascension Via Christi Hospitals Wichita, Wichita, Kansas, United States
Cancer Center of Kansas - Wichita, Wichita, Kansas, United States
Wesley Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas - Winfield, Winfield, Kansas, United States
Lahey Hospital and Medical Center, Burlington, Massachusetts, United States
Bronson Battle Creek, Battle Creek, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids, Michigan, United States
Trinity Health Grand Rapids Hospital, Grand Rapids, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Trinity Health Muskegon Hospital, Muskegon, Michigan, United States
Corewell Health Lakeland Hospitals - Niles Hospital, Niles, Michigan, United States
Corewell Health Reed City Hospital, Reed City, Michigan, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph, Michigan, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital, Saint Joseph, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
University of Michigan Health - West, Wyoming, Michigan, United States
Sanford Joe Lueken Cancer Center, Bemidji, Minnesota, United States
Baptist Memorial Hospital and Cancer Center-Desoto, Southhaven, Mississippi, United States
Saint Louis Cancer and Breast Institute-Ballwin, Ballwin, Missouri, United States
Parkland Health Center-Bonne Terre, Bonne Terre, Missouri, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Southeast Cancer Center, Cape Girardeau, Missouri, United States
MU Health Care Goldschmidt Cancer Center, Jefferson City, Missouri, United States
Freeman Health System, Joplin, Missouri, United States
Mercy Hospital Joplin, Joplin, Missouri, United States
University Health Truman Medical Center, Kansas City, Missouri, United States
Kansas City Veterans Affairs Medical Center, Kansas City, Missouri, United States
The University of Kansas Cancer Center-South, Kansas City, Missouri, United States
University of Kansas Cancer Center - North, Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit, Lee's Summit, Missouri, United States
Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States
Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Missouri Baptist Sullivan Hospital, Sullivan, Missouri, United States
BJC Outpatient Center at Sunset Hills, Sunset Hills, Missouri, United States
Mercy Hospital Washington, Washington, Missouri, United States
Community Hospital of Anaconda, Anaconda, Montana, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Bozeman Health Deaconess Hospital, Bozeman, Montana, United States
Benefis Sletten Cancer Institute, Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Saint Peter's Community Hospital, Helena, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States
Community Medical Center, Missoula, Montana, United States
Hendersonville Hematology and Oncology at Pardee, Hendersonville, North Carolina, United States
Margaret R Pardee Memorial Hospital, Hendersonville, North Carolina, United States
ECU Health Oncology Kinston, Kinston, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst, North Carolina, United States
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States
Cleveland Clinic Mercy Hospital, Canton, Ohio, United States
Dayton Physicians LLC-Miami Valley South, Centerville, Ohio, United States
Miami Valley Hospital South, Centerville, Ohio, United States
Oncology Hematology Care Inc-Kenwood, Cincinnati, Ohio, United States
Good Samaritan Hospital - Dayton, Dayton, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
Dayton Physician LLC - Englewood, Dayton, Ohio, United States
Miami Valley Hospital North, Dayton, Ohio, United States
Armes Family Cancer Center, Findlay, Ohio, United States
Blanchard Valley Hospital, Findlay, Ohio, United States
Orion Cancer Care, Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States
Dayton Physicians LLC-Atrium, Franklin, Ohio, United States
Dayton Physicians LLC-Wayne, Greenville, Ohio, United States
Wayne Hospital, Greenville, Ohio, United States
Greater Dayton Cancer Center, Kettering, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
Dayton Physicians LLC-Signal Point, Middletown, Ohio, United States
Dayton Physicians LLC-Wilson, Sidney, Ohio, United States
Springfield Regional Cancer Center, Springfield, Ohio, United States
Springfield Regional Medical Center, Springfield, Ohio, United States
Dayton Physicians LLC - Troy, Troy, Ohio, United States
Upper Valley Medical Center, Troy, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Saint Charles Health System, Bend, Oregon, United States
Clackamas Radiation Oncology Center, Clackamas, Oregon, United States
Providence Cancer Institute Clackamas Clinic, Clackamas, Oregon, United States
Bay Area Hospital, Coos Bay, Oregon, United States
Providence Newberg Medical Center, Newberg, Oregon, United States
Providence Willamette Falls Medical Center, Oregon City, Oregon, United States
Providence Portland Medical Center, Portland, Oregon, United States
Providence Saint Vincent Medical Center, Portland, Oregon, United States
Penn State Health Saint Joseph Medical Center, Reading, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
Baptist Memorial Hospital and Cancer Center-Collierville, Collierville, Tennessee, United States
Baptist Memorial Hospital and Cancer Center-Memphis, Memphis, Tennessee, United States
M D Anderson Cancer Center, Houston, Texas, United States
Audie L Murphy VA Hospital, San Antonio, Texas, United States
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio, San Antonio, Texas, United States
University Hospital, San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Providence Regional Cancer System-Aberdeen, Aberdeen, Washington, United States
PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States
Providence Regional Cancer System-Centralia, Centralia, Washington, United States
Swedish Cancer Institute-Edmonds, Edmonds, Washington, United States
Providence Regional Cancer Partnership, Everett, Washington, United States
Swedish Cancer Institute-Issaquah, Issaquah, Washington, United States
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
Providence Regional Cancer System-Lacey, Lacey, Washington, United States
PeaceHealth Saint John Medical Center, Longview, Washington, United States
Pacific Gynecology Specialists, Seattle, Washington, United States
Swedish Medical Center-Ballard Campus, Seattle, Washington, United States
Kaiser Permanente Washington, Seattle, Washington, United States
Swedish Medical Center-Cherry Hill, Seattle, Washington, United States
Swedish Medical Center-First Hill, Seattle, Washington, United States
Providence Regional Cancer System-Shelton, Shelton, Washington, United States
MultiCare Deaconess Cancer and Blood Specialty Center - Valley, Spokane Valley, Washington, United States
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown, Spokane, Washington, United States
MultiCare Deaconess Cancer and Blood Specialty Center - North, Spokane, Washington, United States
PeaceHealth Southwest Medical Center, Vancouver, Washington, United States
Providence Saint Mary Regional Cancer Center, Walla Walla, Washington, United States
Providence Regional Cancer System-Yelm, Yelm, Washington, United States
Billings Clinic-Cody, Cody, Wyoming, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Name: Athanassios (Ethan) Argiris
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR