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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Athanassios (Ethan) Argiris

Affiliation: SWOG Cancer Research Network

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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