Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer
Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v7, Stage III Rectal Cancer AJCC v7
About this trial
This is an interventional treatment trial for Rectal Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Diagnosis of adenocarcinoma of the rectum with the major portion of the tumor intact; Note: prior to randomization, the investigator must specify and document each of the following:
- Distance of the lowest tumor margin from the anal verge; and
- Intent for sphincter sparing or non-sphincter sparing surgical resection according to the primary surgeon; and
- The majority of the untreated tumor must be < 12 cm from the anal verge or below the peritoneal reflection as determined by the treating surgeon
The tumor must be clinically determined to be locally advanced stage II or stage III rectal cancer, and must also meet any ONE of the following criteria:
- Distal location (as defined by measurement on magnetic resonance imaging [MRI], transrectal ultrasound [ERUS]/pelvic computed tomography [CT] [with IV contrast] scan or palpable on digital rectal examination [DRE]): cT3-4 =< 5 cm from the anal verge, any N
- Bulky: any cT4 or evidence that the tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on MRI or ERUS/pelvic CT (with IV contrast) scan
- High risk for metastatic disease with 4 or more regional lymph nodes (cN2); clinical nodal or "cN" status for eligibility includes the total number of nodes (N2 = 4 or more) in the mesorectal and superior rectal stations measuring >= 1.0 cm in any axis on cross sectional or endoscopic imaging; Note: nodes must measure 1.0 cm or greater to be considered positive for this eligibility requirement
Not a candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy (as planned by the primary surgeon)
- Note: clinical stage of the primary tumor and nodes may be determined locally by rectal endoscopic ultrasound or pelvic MRI (pelvic MRI is strongly preferred); CT scan with IV contrast is acceptable provided there is evidence of T4 and/or N2 disease
- Patients must have the ability to swallow and retain oral medication
- Absolute neutrophil count (ANC) must be >= 1200/mm^3 (within 28 days before randomization)
- Platelet count must be >= 100,000/mm^3 (within 28 days before randomization)
- Hemoglobin must be >= 10 g/dL (within 28 days before randomization)
- Total bilirubin must be =< ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin (within 28 days before randomization)
- Alkaline phosphatase must be =< 3 x ULN for the lab (within 28 days before randomization)
Aspartate aminotransferase (AST) must be =< 3 x ULN for the lab (within 28 days before randomization);
- Note: if alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be =< 3 x ULN; if both were performed, the AST must also be =< 3 x ULN; if AST and/or ALT is >= ULN but =< 3 x ULN, serologic testing for hepatitis B and C must be performed and results for viral infection must be negative
- Serum creatinine =< ULN for the lab and measured or calculated creatinine clearance > 60 mL/min (within 28 days before randomization)
- Serum potassium, magnesium, and calcium levels within 28 days before randomization must be within normal limits (WNL) for the lab
- International normalized ratio of prothrombin time (INR) within 28 days before randomization must be =< ULN for the lab; patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history
Patients with acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease must:
- Have a cluster of differentiation (CD)4 count >= 200 cells/uL within 30 days before beginning study therapy
- Be off all antiretroviral therapy (prophylaxis/treatment) more than 60 days before beginning study therapy, and
- Have no evidence of opportunistic infections
- Pregnancy test (urine or serum beta-human chorionic gonadotropin [HCG]) done within 72 hours before randomization must be negative (for women of childbearing potential only); if urine pregnancy results are positive or cannot be confirmed as negative, a serum pregnancy test will be required
Exclusion Criteria:
- Rectal cancer histology other than adenocarcinoma (i.e., sarcoma, lymphoma, squamous cell carcinoma, mucosal melanoma, etc.)
Definitive clinical or radiologic evidence of metastatic disease; required imaging studies must have been performed within 28 days prior to randomization; Note: Distant clinical staging to exclude patients with overt metastatic disease is determined by:
- Chest: CT scan (preferred); chest x-ray posterioranterior (PA) and lateral (acceptable); or positron emission tomography (PET) scan (acceptable)
- Abdomen: CT scan with IV contrast (preferred); or MRI (acceptable)
Pelvis: MRI (preferred) or CT scan with IV contrast (acceptable)
- (It is recommended that the same imaging tests that are performed before randomization be used at follow-up time points; Note: CT scans of the abdomen and pelvis must be performed with IV contrast)
- History of prior invasive rectal malignancy, regardless of disease-free interval
Cardiac disease that would preclude the use of any of the drugs included in the GI002 treatment regimen; this includes but is not limited to:
- Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker
- Ventricular tachycardia or supraventricular tachycardia that requires treatment with class Ia antiarrhythmic drugs (e.g., quinidine, procainamide, disopyramide) or class III antiarrhythmic drug (e.g., sotalol, amiodarone, dofetilide); use of other antiarrhythmic drugs is permitted
- Second- or third-degree atrioventricular (AV) block unless treated with a permanent pacemaker
- Complete left bundle branch block (LBBB)
- History of long QT syndrome
- Corrected QT (QTc) >= 450 ms
- Sensory or motor neuropathy >= grade 2
- History of, or any evidence of active, non-infectious pneumonitis
- Active inflammatory bowel disease (i.e., patients requiring current medical interventions or who are symptomatic) or have a history of abdominal surgery or other medical condition that may, in the opinion of the treating physician, interfere with gastrointestinal motility or absorption
- Active autoimmune disease that has required systemic treatment within the past 2 years (i.e., with use of modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
- History of active TB (Bacillus tuberculosis)
- Active or chronic infection requiring systemic therapy
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy; the use of physiologic doses of corticosteroids may be approved after consultation with the study principal investigator (PI)
- Active seizure disorder uncontrolled by medication
- Any antineoplastic therapy for this cancer before randomization
- Synchronous colon cancer
- Other invasive cancer within 5 years before randomization; exceptions are colonic polyps, non-melanoma skin cancer or carcinoma-in-situ of the cervix
- Antineoplastic therapy (e.g. chemotherapy or targeted therapy) for other invasive cancer within 5 years before randomization; (for the purposes of this study, hormonal therapy is not considered chemotherapy)
- Prior treatment with an investigational compound being tested in this study (e.g., poly ADP ribose polymerase [PARP] inhibitor, anti-PD-1, anti-PD-L1, or anti-PD-L2)
- Receipt of live vaccination within 28 days before randomization; seasonal flu vaccines that do not contain live virus are permitted
- Major surgery within 4 weeks before randomization
- Any therapeutic pelvic radiation
- Known homozygous DPD (dihydro pyrimidine dehydrogenase) deficiency
Any of the following because this study involves agents that have known or potential genotoxic or mutagenic, and teratogenic effects:
- Pregnant women
- Nursing women who are unwilling to discontinue nursing
- Men or women of childbearing potential who are unwilling to employ adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 4 months after the last dose of study therapy
- Co-morbid illnesses or other concurrent disease that, in the judgement of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Southern Cancer Center PC-Mobile
- Southern Cancer Center PC-Providence
- Southern Cancer Center PC-Springhill
- University of South Alabama Mitchell Cancer Institute
- Fairbanks Memorial Hospital
- Banner MD Anderson Cancer Center
- Mayo Clinic in Arizona
- University of Arizona Cancer Center-Orange Grove Campus
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- Mercy Hospital Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- University of Arkansas for Medical Sciences
- Kaiser Permanente-Anaheim
- Kaiser Permanente-Deer Valley Medical Center
- PCR Oncology
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- AIS Cancer Center at San Joaquin Community Hospital
- Alta Bates Summit Medical Center-Herrick Campus
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Eden Hospital Medical Center
- Enloe Medical Center
- City of Hope Corona
- City of Hope Comprehensive Cancer Center
- Kaiser Permanente Dublin
- Kaiser Permanente-Fremont
- Fresno Cancer Center
- Kaiser Permanente-Fresno
- UC San Diego Moores Cancer Center
- City of Hope Antelope Valley
- Kaiser Permanente Los Angeles Medical Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Cedars Sinai Medical Center
- Fremont - Rideout Cancer Center
- Memorial Medical Center
- Kaiser Permanente-Modesto
- Palo Alto Medical Foundation-Camino Division
- Sutter Cancer Research Consortium
- Kaiser Permanente Oakland-Broadway
- Kaiser Permanente-Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Kaiser Permanente-Rancho Cordova Cancer Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Riverside
- Rohnert Park Cancer Center
- Kaiser Permanente-Roseville
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- The Permanente Medical Group-Roseville Radiation Oncology
- Kaiser Permanente Downtown Commons
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-South Sacramento
- South Sacramento Cancer Center
- Kaiser Permanente - Sacramento
- Kaiser Permanente-San Diego Zion
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Marcos
- Kaiser Permanente-San Rafael
- Kaiser San Rafael-Gallinas
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- City of Hope South Pasadena
- Kaiser Permanente Cancer Treatment Center
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Palo Alto Medical Foundation-Sunnyvale
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- City of Hope Upland
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- Presbyterian Intercommunity Hospital
- Rocky Mountain Cancer Centers-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
- Porter Adventist Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- SCL Health Saint Joseph Hospital
- Swedish Medical Center
- Poudre Valley Hospital
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Longmont United Hospital
- McKee Medical Center
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Smilow Cancer Hospital Care Center - Guilford
- Hartford Hospital
- Midstate Medical Center
- The Hospital of Central Connecticut
- Smilow Cancer Center/Yale-New Haven Hospital
- Yale University
- Yale-New Haven Hospital North Haven Medical Center
- William Backus Hospital
- Smilow Cancer Hospital Care Center-Trumbull
- Smilow Cancer Hospital Care Center - Waterford
- 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
- University of Florida Health Science Center - Gainesville
- Mayo Clinic in Florida
- Orlando Health Cancer Institute
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- Northeast Georgia Medical Center-Gainesville
- Memorial Health University Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Pali Momi Medical Center
- Queen's Cancer Center - Pearlridge
- The Cancer Center of Hawaii-Pali Momi
- Hawaii Cancer Care Inc - Waterfront Plaza
- Island Urology
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Kuakini Medical Center
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and Children
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Idaho Urologic Institute-Meridian
- Kootenai Clinic Cancer Services - Post Falls
- Northwest Community Hospital
- Rush - Copley Medical Center
- Illinois CancerCare-Bloomington
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Centralia Oncology Clinic
- Northwestern University
- University of Chicago Comprehensive Cancer Center
- Advocate Illinois Masonic Medical Center
- Carle at The Riverfront
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Western Illinois Cancer Treatment Center
- Northwestern Medicine Cancer Center Delnor
- Ingalls Memorial Hospital
- Northwestern Medicine Lake Forest Hospital
- 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
- Illinois CancerCare-Ottawa Clinic
- 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
- 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
- Northwestern Medicine Cancer Center Warrenville
- Deaconess Clinic Downtown
- Parkview Hospital Randallia
- Parkview Regional Medical Center
- Goshen Center for Cancer Care
- Franciscan Health Indianapolis
- Woodland Cancer Care Center
- Memorial Regional Cancer Center Day Road
- Franciscan Health Mooresville
- Chancellor Center for Oncology
- Reid Health
- Memorial Hospital of South Bend
- Mary Greeley Medical Center
- McFarland Clinic - Ames
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- 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
- University of Iowa/Holden Comprehensive Cancer Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- University of Kansas Cancer Center
- Lawrence Memorial Hospital
- Olathe Health Cancer Center
- University of Kansas Cancer Center-Overland Park
- Ascension Via Christi - Pittsburg
- Cancer Center of Kansas - Salina
- Salina Regional Health Center
- Cotton O'Neil Cancer Center / Stormont Vail Health
- University of Kansas Health System Saint Francis Campus
- Cancer Center of Kansas - Wellington
- University of Kansas Hospital-Westwood Cancer Center
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Wesley Medical Center
- Cancer Center of Kansas - Winfield
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- Jewish Hospital
- UofL Health Medical Center Northeast
- LSU Health Baton Rouge-North Clinic
- Louisiana Hematology Oncology Associates LLC
- Mary Bird Perkins Cancer Center
- Our Lady of the Lake Physicians Group - Medical Oncology
- Mary Bird Perkins Cancer Center - Covington
- Northshore Oncology Associates-Covington
- Mary Bird Perkins Cancer Center - Houma
- Oncology Center of The South Incorporated
- Ochsner Medical Center Jefferson
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Greater Baltimore Medical Center
- TidalHealth Peninsula Regional
- Massachusetts General Hospital Cancer Center
- Brigham and Women's Hospital
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- Berkshire Medical Center - Cancer Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- McLaren Cancer Institute-Bay City
- Henry Ford Cancer Institute-Downriver
- McLaren Cancer Institute-Clarkston
- Henry Ford Macomb Hospital-Clinton Township
- Beaumont Hospital - Dearborn
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Ascension Saint John Hospital
- Weisberg Cancer Treatment Center
- Beaumont Hospital - Farmington Hills
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- McLaren Cancer Institute-Flint
- Singh and Arora Hematology Oncology PC
- Helen DeVos Children's Hospital at Spectrum Health
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Karmanos Cancer Institute at McLaren Greater Lansing
- Sparrow Hospital
- McLaren Cancer Institute-Lapeer Region
- Trinity Health Saint Mary Mercy Livonia Hospital
- McLaren Cancer Institute-Macomb
- McLaren Cancer Institute-Central Michigan
- Trinity Health Muskegon Hospital
- Lakeland Hospital Niles
- Ascension Providence Hospitals - Novi
- McLaren Cancer Institute-Owosso
- McLaren Cancer Institute-Northern Michigan
- 21st Century Oncology-Pontiac
- Saint Joseph Mercy Oakland
- McLaren-Port Huron
- Spectrum Health Reed City Hospital
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Ascension Providence Hospitals - Southfield
- Munson Medical Center
- William Beaumont Hospital - Troy
- Saint John Macomb-Oakland Hospital
- Henry Ford West Bloomfield Hospital
- University of Michigan Health - West
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- 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
- Saint Luke's Hospital of Duluth
- 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
- Essentia Health - Park Rapids
- 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
- Essentia Health Virginia Clinic
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Baptist Cancer Center-Grenada
- 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
- Saint Francis Medical Center
- Southeast Cancer Center
- Capital Region Southwest Campus
- Freeman Health System
- Research Medical Center
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Mercy Hospital South
- Missouri Baptist Medical Center
- Mercy Hospital Saint Louis
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Kalispell Regional Medical Center
- Community Medical Hospital
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Nebraska Hematology and Oncology
- Nebraska Cancer Research Center
- Southeast Nebraska Cancer Center - 68th Street Place
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Nebraska Cancer Specialists - Omaha
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- Regional West Medical Center Cancer Center
- OptumCare Cancer Care at Seven Hills
- OptumCare Cancer Care at Charleston
- Radiation Oncology Centers of Nevada Central
- GenesisCare USA - Las Vegas
- OptumCare Cancer Care at MountainView
- Comprehensive Cancer Centers of Nevada
- OptumCare Cancer Care at Fort Apache
- Renown Regional Medical Center
- Saint Mary's Regional Medical Center
- Radiation Oncology Associates
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Englewood Hospital and Medical Center
- Virtua Samson Cancer Center
- Virtua Memorial
- Rutgers Cancer Institute of New Jersey
- Robert Wood Johnson University Hospital Somerset
- Holy Name Hospital
- Virtua Voorhees
- University of New Mexico Cancer Center
- New Mexico Oncology Hematology Consultants
- Christus Saint Vincent Regional Cancer Center
- Northwell Health Imbert Cancer Center
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- Glens Falls Hospital
- Northwell Health/Center for Advanced Medicine
- North Shore University Hospital
- Garnet Health Medical Center
- Long Island Jewish Medical Center
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- University of Rochester
- Staten Island University Hospital
- State University of New York Upstate Medical University
- Atrium Health Stanly/LCI-Albemarle
- Mission Hospital
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Presbyterian Medical Center
- Atrium Health Pineville/LCI-Pineville
- Atrium Health University City/LCI-University
- Atrium Health Cabarrus/LCI-Concord
- Novant Health Presbyterian Medical Center Huntersville
- Matthews Radiation Oncology Center
- Atrium Health Union/LCI-Union
- UNC Rex Healthcare
- Atrium Health Cleveland/LCI-Cleveland
- Wake Forest University Health Sciences
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Essentia Health - Jamestown Clinic
- Cleveland Clinic Akron General
- UHHS-Chagrin Highlands Medical Center
- Indu and Raj Soin Medical Center
- Cleveland Clinic Mercy Hospital
- Dayton Physicians LLC-Miami Valley South
- Miami Valley Hospital South
- Geauga Hospital
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- Case Western Reserve University
- Ohio State University Comprehensive Cancer Center
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Mercy Cancer Center-Elyria
- 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
- Greater Dayton Cancer Center
- Kettering Medical Center
- Toledo Clinic Cancer Centers-Maumee
- UH Seidman Cancer Center at Lake Health Mentor Campus
- UH Seidman Cancer Center at Southwest General Hospital
- University Hospitals Parma Medical Center
- University Hospitals Portage Medical Center
- UH Seidman Cancer Center at Firelands Regional Medical Center
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- 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
- University Hospitals Sharon Health Center
- University of Cincinnati Cancer Center-West Chester
- UH Seidman Cancer Center at Saint John Medical Center
- UHHS-Westlake Medical 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
- Legacy Mount Hood Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Kaiser Permanente Northwest
- Jefferson Abington Hospital
- Lehigh Valley Hospital-Cedar Crest
- Lehigh Valley Hospital - Muhlenberg
- Crozer-Keystone Regional Cancer Center at Broomall
- Christiana Care Health System-Concord Health Center
- Geisinger Medical Center
- Northeast Radiation Oncology Center
- Pocono Medical Center
- Saint Vincent Hospital
- Crozer Regional Cancer Center at Brinton Lake
- Jefferson Hospital
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- Forbes Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Temple University Hospital
- Allegheny General Hospital
- Geisinger Medical Oncology-Selinsgrove
- Grand View Hospital
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- Asplundh Cancer Pavilion
- Lankenau Medical Center
- AnMed Health Cancer Center
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South Carolina
- Gibbs Cancer Center-Gaffney
- Prisma Health Cancer Institute - Faris
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Gibbs Cancer Center-Pelham
- Rock Hill Radiation Therapy Center
- Levine Cancer Institute-Rock Hill
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical Center
- MGC Hematology Oncology-Union
- Avera Cancer Institute-Aberdeen
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Memorial Hospital
- Baptist Memorial Hospital and Cancer Center-Collierville
- The West Clinic - Wolf River
- The West Clinic - Mid-Town
- Baptist Memorial Hospital and Cancer Center-Memphis
- University of Tennessee Health Science Center
- Vanderbilt Breast Center at One Hundred Oaks
- Vanderbilt University/Ingram Cancer Center
- Saint Joseph Regional Cancer Center
- Parkland Memorial Hospital
- Baylor University Medical Center
- UT Southwestern/Simmons Cancer Center-Dallas
- University of Texas Medical Branch
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Ben Taub General Hospital
- M D Anderson Cancer Center
- UTMB Cancer Center at Victory Lakes
- Covenant Medical Center-Lakeside
- Scott and White Memorial Hospital
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Riverton Hospital
- Saint George Regional Medical Center
- Utah Cancer Specialists-Salt Lake City
- LDS Hospital
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont Medical Center
- University of Vermont and State Agricultural College
- Norris Cotton Cancer Center-North
- Sentara Cancer Institute at Sentara CarePlex Hospital
- Sentara Leigh Hospital
- Sentara Norfolk General Hospital
- Virginia Commonwealth University/Massey Cancer Center
- MultiCare Auburn Medical Center
- Overlake Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Virginia Mason Federal Way Medical Center
- Tacoma/Valley Radiation Oncology Centers-Gig Harbor
- MultiCare Gig Harbor Medical Park
- Tri-Cities Cancer Center
- Seattle Cancer Care Alliance at EvergreenHealth
- Skagit Regional Health Cancer Care Center
- Skagit Valley Hospital
- MultiCare Good Samaritan Hospital
- Tacoma/Valley Radiation Oncology Centers-Puyallup
- Valley Medical Center
- Virginia Mason Medical Center
- FHCC South Lake Union
- Fred Hutchinson Cancer Research Center
- FHCC at Northwest Hospital
- University of Washington Medical Center - Montlake
- Spokane Valley Cancer Center-Mayfair
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- Tacoma/Valley Radiation Oncology Centers-Saint Joe's
- Legacy Salmon Creek Hospital
- Wenatchee Valley Hospital and Clinics
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- United Hospital Center
- West Virginia University Charleston Division
- West Virginia University Healthcare
- Camden Clark Medical Center
- Wheeling Hospital/Schiffler Cancer Center
- Duluth Clinic Ashland
- Northwest Wisconsin Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- Marshfield Clinic Cancer Center at Sacred Heart
- Marshfield Medical Center-EC Cancer Center
- Aurora Health Center-Fond du Lac
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Aurora BayCare Medical Center
- UW Cancer Center Johnson Creek
- Aurora Cancer Care-Kenosha South
- University of Wisconsin Carbone Cancer Center
- Aurora Bay Area Medical Group-Marinette
- Marshfield Medical Center-Marshfield
- Froedtert Menomonee Falls Hospital
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- Cancer Center of Western Wisconsin
- ProHealth Oconomowoc Memorial Hospital
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Marshfield Medical Center-Rice Lake
- Vince Lombardi Cancer Clinic-Sheboygan
- Marshfield Medical Center-River Region at Stevens Point
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- UW Cancer Center at ProHealth Care
- Marshfield Clinic-Wausau Center
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Froedtert West Bend Hospital/Kraemer Cancer Center
- Diagnostic and Treatment Center
- Marshfield Medical Center - Weston
- Cancer Center-Metro Medical Center Bayamon
- Doctors Cancer Center
- San Juan Community Oncology Group
- Centro Comprensivo de Cancer de UPR
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Arm I (mFOLFOX6, RT, capecitabine)
Arm II (mFOLFOX6, RT, capecitabine, veliparib)
Arm III (mFOLFOX6, RT, capecitabine, pembrolizumab)
Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Participants assigned to Arm I concurrently with Arm II or with Arm III.
Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity.
ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 cycles in the absence of disease progression or unacceptable toxicity.