Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Who is this study for? Children/Young Adults with Liver Cancer
Status: Recruiting
Location: See all (201) locations...
Intervention Type: Drug, Other, Procedure
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

This partially randomized phase II/III trial studies how well, in combination with surgery, cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or hepatocellular carcinoma. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, 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. Giving combination chemotherapy may kill more tumor cells than one type of chemotherapy alone.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 30
Healthy Volunteers: No
View:

• Patients in Group F must have a body surface area (BSA) >= 0.6 m^2

• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score

• Patients must be newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma, except as noted below; patients with a diagnosis of hepatocellular neoplasm, not otherwise specified, should be classified and treated per hepatoblastoma treatment arms; note that rapid central pathology review is required in some cases; please note: all patients with histology as assessed by the institutional pathologist consistent with pure small cell undifferentiated (SCU) HB will be required to have testing for INI1/SMARCB1 by immunohistochemistry (IHC) according to the practices at the institution

• Patients with histology consistent with pure SCU must have positive INI1/SMARCB1 staining

• For all Group A patients, WDF status as determined by rapid review will be used to further stratify patients to Group A1 or A2

• For Groups B, C and D, rapid review is required if patients are either >= 8 years of age or have an alphafetoprotein (AFP) =< 100 at diagnosis

• For all Groups E and F patients, rapid central pathology review is required

• In emergency situations when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy

• Clinical situations in which emergent treatment may be indicated include, but are not limited to, the following circumstances:

• Anatomic or mechanical compromise of critical organ function by tumor (e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.)

• Uncorrectable coagulopathy

• For a patient to maintain eligibility for AHEP1531 when emergent treatment is given, the following must occur:

• The patient must have a clinical diagnosis of hepatoblastoma, including an elevated alphafetoprotein (AFP), and must meet all AHEP1531 eligibility criteria at the time of emergent treatment

• Patient must be enrolled on AHEP1531 prior to initiating protocol therapy; a patient will be ineligible if any chemotherapy is administered prior to AHEP1531 enrollment

• Note: If the patient receives AHEP1531 chemotherapy emergently PRIOR to undergoing a diagnostic biopsy, pathologic review of material obtained in the future during either biopsy or surgical resection must either confirm the diagnosis of hepatoblastoma or not reveal another pathological diagnosis to be included in the analysis of the study aims

• Patients may have had surgical resection of the hepatic malignancy prior to enrollment; all other anti-cancer therapy for the current liver lesion is prohibited

• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 or

• A serum creatinine based on age/gender as follows:

• Age: maximum serum creatinine (mg/dL)

• 1 month to < 6 months: 0.4 (male and female)

• 6 months to < 1 year: 0.5 (male and female)

• 1 to < 2 years: 06 (male and female)

• 13 to < 16 years: 1.5 (male), 1.4 (female)

• >= 16 years: 1.7 (male), 1.4 (female)

• Total bilirubin =< 5 x upper limit of normal (ULN) for age

• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 10 x upper limit of normal (ULN) for age

• Shortening fraction of >= 28% by echocardiogram (for patients on doxorubicin-containing regimens [Groups C, D, E2, and F] assessed within 8 weeks prior to study enrollment) or

• Ejection fraction of >= 47% by echocardiogram or radionuclide angiogram (for patients on doxorubicin-containing regimens [Groups C, D, E2, and F] assessed within 8 weeks prior to study enrollment)

• Group F patients only: QT/corrected QT (QTc) interval =< 450 milliseconds for males and =< 470 milliseconds for females (assessed within 8 weeks prior to study enrollment)

• Normal pulmonary function tests (including diffusion capacity of the lung for carbon monoxide [DLCO]) if there is clinical indication for determination (e.g. dyspnea at rest, known requirement for supplemental oxygen) (for patients receiving chemotherapy [Groups A, B, C, D, E2, F]); for patients who do not have respiratory symptoms or requirement for supplemental oxygen, pulmonary function tests (PFTs) are NOT required

• All patients and/or their parents or legal guardians must sign a written informed consent

• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Locations
United States
Alaska
Providence Alaska Medical Center
Recruiting
Anchorage
Alabama
Children's Hospital of Alabama
Recruiting
Birmingham
Arkansas
Arkansas Children's Hospital
Recruiting
Little Rock
Arizona
Banner Children's at Desert
Recruiting
Mesa
Phoenix Childrens Hospital
Recruiting
Phoenix
California
Kaiser Permanente Downey Medical Center
Recruiting
Downey
Loma Linda University Medical Center
Recruiting
Loma Linda
Miller Children's and Women's Hospital Long Beach
Recruiting
Long Beach
Children's Hospital Los Angeles
Recruiting
Los Angeles
Mattel Children's Hospital UCLA
Recruiting
Los Angeles
Valley Children's Hospital
Recruiting
Madera
Kaiser Permanente-Oakland
Recruiting
Oakland
UCSF Benioff Children's Hospital Oakland
Recruiting
Oakland
Children's Hospital of Orange County
Recruiting
Orange
Lucile Packard Children's Hospital Stanford University
Recruiting
Palo Alto
Sutter Medical Center Sacramento
Recruiting
Sacramento
University of California Davis Comprehensive Cancer Center
Recruiting
Sacramento
Naval Medical Center -San Diego
Recruiting
San Diego
Rady Children's Hospital - San Diego
Recruiting
San Diego
UCSF Medical Center-Mission Bay
Recruiting
San Francisco
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Recruiting
Torrance
Colorado
Children's Hospital Colorado
Recruiting
Aurora
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Recruiting
Denver
Connecticut
Connecticut Children's Medical Center
Recruiting
Hartford
Yale University
Recruiting
New Haven
Washington, D.c.
Children's National Medical Center
Recruiting
Washington
MedStar Georgetown University Hospital
Recruiting
Washington
Delaware
Alfred I duPont Hospital for Children
Recruiting
Wilmington
Florida
Golisano Children's Hospital of Southwest Florida
Recruiting
Fort Myers
University of Florida Health Science Center - Gainesville
Recruiting
Gainesville
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Recruiting
Hollywood
Nemours Children's Clinic-Jacksonville
Recruiting
Jacksonville
Nicklaus Children's Hospital
Recruiting
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Recruiting
Miami
AdventHealth Orlando
Recruiting
Orlando
Arnold Palmer Hospital for Children
Recruiting
Orlando
Nemours Children's Hospital
Recruiting
Orlando
Sacred Heart Hospital
Recruiting
Pensacola
Johns Hopkins All Children's Hospital
Recruiting
Saint Petersburg
Saint Joseph's Hospital/Children's Hospital-Tampa
Recruiting
Tampa
Saint Mary's Hospital
Recruiting
West Palm Beach
Georgia
Children's Healthcare of Atlanta - Egleston
Recruiting
Atlanta
Augusta University Medical Center
Recruiting
Augusta
Memorial Health University Medical Center
Recruiting
Savannah
Hawaii
Kapiolani Medical Center for Women and Children
Recruiting
Honolulu
Iowa
Blank Children's Hospital
Recruiting
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Recruiting
Iowa City
Idaho
Saint Luke's Cancer Institute - Boise
Recruiting
Boise
Illinois
Lurie Children's Hospital-Chicago
Recruiting
Chicago
University of Chicago Comprehensive Cancer Center
Recruiting
Chicago
University of Illinois
Recruiting
Chicago
Loyola University Medical Center
Recruiting
Maywood
Advocate Children's Hospital-Oak Lawn
Recruiting
Oak Lawn
Advocate Children's Hospital-Park Ridge
Recruiting
Park Ridge
Saint Jude Midwest Affiliate
Recruiting
Peoria
Southern Illinois University School of Medicine
Recruiting
Springfield
Indiana
Riley Hospital for Children
Recruiting
Indianapolis
Kentucky
University of Kentucky/Markey Cancer Center
Recruiting
Lexington
Norton Children's Hospital
Recruiting
Louisville
Louisiana
Children's Hospital New Orleans
Recruiting
New Orleans
Ochsner Medical Center Jefferson
Recruiting
New Orleans
Massachusetts
Dana-Farber Cancer Institute
Recruiting
Boston
Massachusetts General Hospital Cancer Center
Recruiting
Boston
Tufts Children's Hospital
Active, not recruiting
Boston
Baystate Medical Center
Recruiting
Springfield
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Recruiting
Baltimore
Sinai Hospital of Baltimore
Recruiting
Baltimore
University of Maryland/Greenebaum Cancer Center
Recruiting
Baltimore
Walter Reed National Military Medical Center
Recruiting
Bethesda
Maine
Eastern Maine Medical Center
Recruiting
Bangor
Maine Children's Cancer Program
Recruiting
Scarborough
Michigan
C S Mott Children's Hospital
Recruiting
Ann Arbor
Ascension Saint John Hospital
Suspended
Detroit
Children's Hospital of Michigan
Recruiting
Detroit
Wayne State University/Karmanos Cancer Institute
Recruiting
Detroit
Michigan State University Clinical Center
Recruiting
East Lansing
Helen DeVos Children's Hospital at Spectrum Health
Recruiting
Grand Rapids
Spectrum Health at Butterworth Campus
Suspended
Grand Rapids
Bronson Methodist Hospital
Recruiting
Kalamazoo
West Michigan Cancer Center
Suspended
Kalamazoo
Beaumont Children's Hospital-Royal Oak
Recruiting
Royal Oak
Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Recruiting
Minneapolis
University of Minnesota/Masonic Cancer Center
Recruiting
Minneapolis
Mayo Clinic in Rochester
Recruiting
Rochester
Missouri
Columbia Regional
Recruiting
Columbia
Children's Mercy Hospitals and Clinics
Recruiting
Kansas City
Cardinal Glennon Children's Medical Center
Recruiting
Saint Louis
Mercy Hospital Saint Louis
Recruiting
Saint Louis
Washington University School of Medicine
Recruiting
Saint Louis
Mississippi
University of Mississippi Medical Center
Recruiting
Jackson
North Carolina
Mission Hospital
Recruiting
Asheville
UNC Lineberger Comprehensive Cancer Center
Recruiting
Chapel Hill
Carolinas Medical Center/Levine Cancer Institute
Recruiting
Charlotte
Novant Health Presbyterian Medical Center
Recruiting
Charlotte
Duke University Medical Center
Recruiting
Durham
Wake Forest University Health Sciences
Recruiting
Winston-salem
Nebraska
Children's Hospital and Medical Center of Omaha
Recruiting
Omaha
University of Nebraska Medical Center
Recruiting
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center
Recruiting
Lebanon
New Jersey
Hackensack University Medical Center
Recruiting
Hackensack
Morristown Medical Center
Recruiting
Morristown
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Recruiting
New Brunswick
Newark Beth Israel Medical Center
Recruiting
Newark
Saint Joseph's Regional Medical Center
Recruiting
Paterson
New Mexico
University of New Mexico Cancer Center
Recruiting
Albuquerque
Nevada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Recruiting
Las Vegas
Summerlin Hospital Medical Center
Recruiting
Las Vegas
Sunrise Hospital and Medical Center
Recruiting
Las Vegas
University Medical Center of Southern Nevada
Recruiting
Las Vegas
Renown Regional Medical Center
Recruiting
Reno
New York
Albany Medical Center
Recruiting
Albany
Montefiore Medical Center - Moses Campus
Recruiting
Bronx
Roswell Park Cancer Institute
Recruiting
Buffalo
The Steven and Alexandra Cohen Children's Medical Center of New York
Recruiting
New Hyde Park
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Recruiting
New York
Memorial Sloan Kettering Cancer Center
Recruiting
New York
Mount Sinai Hospital
Recruiting
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Recruiting
New York
Stony Brook University Medical Center
Recruiting
Stony Brook
State University of New York Upstate Medical University
Recruiting
Syracuse
New York Medical College
Recruiting
Valhalla
Ohio
Children's Hospital Medical Center of Akron
Recruiting
Akron
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati
Cleveland Clinic Foundation
Recruiting
Cleveland
Rainbow Babies and Childrens Hospital
Recruiting
Cleveland
Nationwide Children's Hospital
Recruiting
Columbus
Dayton Children's Hospital
Recruiting
Dayton
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Recruiting
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City
Oregon
Legacy Emanuel Children's Hospital
Recruiting
Portland
Oregon Health and Science University
Recruiting
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Recruiting
Allentown
Geisinger Medical Center
Recruiting
Danville
Penn State Children's Hospital
Recruiting
Hershey
Children's Hospital of Philadelphia
Recruiting
Philadelphia
Saint Christopher's Hospital for Children
Recruiting
Philadelphia
Children's Hospital of Pittsburgh of UPMC
Recruiting
Pittsburgh
Rhode Island
Rhode Island Hospital
Recruiting
Providence
South Carolina
Medical University of South Carolina
Recruiting
Charleston
Prisma Health Richland Hospital
Recruiting
Columbia
BI-LO Charities Children's Cancer Center
Recruiting
Greenville
South Dakota
Sanford USD Medical Center - Sioux Falls
Recruiting
Sioux Falls
Tennessee
East Tennessee Childrens Hospital
Recruiting
Knoxville
Saint Jude Children's Research Hospital
Recruiting
Memphis
The Children's Hospital at TriStar Centennial
Recruiting
Nashville
Vanderbilt University/Ingram Cancer Center
Recruiting
Nashville
Texas
Dell Children's Medical Center of Central Texas
Recruiting
Austin
Driscoll Children's Hospital
Recruiting
Corpus Christi
Medical City Dallas Hospital
Recruiting
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Recruiting
Dallas
El Paso Children's Hospital
Recruiting
El Paso
Cook Children's Medical Center
Recruiting
Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Recruiting
Houston
M D Anderson Cancer Center
Recruiting
Houston
Covenant Children's Hospital
Recruiting
Lubbock
UMC Cancer Center / UMC Health System
Recruiting
Lubbock
Children's Hospital of San Antonio
Recruiting
San Antonio
Methodist Children's Hospital of South Texas
Recruiting
San Antonio
University of Texas Health Science Center at San Antonio
Recruiting
San Antonio
Scott and White Memorial Hospital
Recruiting
Temple
Utah
Primary Children's Hospital
Recruiting
Salt Lake City
Virginia
University of Virginia Cancer Center
Recruiting
Charlottesville
Inova Fairfax Hospital
Recruiting
Falls Church
Children's Hospital of The King's Daughters
Recruiting
Norfolk
Naval Medical Center - Portsmouth
Recruiting
Portsmouth
Virginia Commonwealth University/Massey Cancer Center
Recruiting
Richmond
Vermont
University of Vermont and State Agricultural College
Recruiting
Burlington
Washington
Seattle Children's Hospital
Recruiting
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
Recruiting
Spokane
Madigan Army Medical Center
Recruiting
Tacoma
Mary Bridge Children's Hospital and Health Center
Recruiting
Tacoma
Wisconsin
University of Wisconsin Carbone Cancer Center
Recruiting
Madison
Marshfield Medical Center-Marshfield
Recruiting
Marshfield
Children's Hospital of Wisconsin
Recruiting
Milwaukee
West Virginia
West Virginia University Charleston Division
Recruiting
Charleston
West Virginia University Healthcare
Recruiting
Morgantown
Other Locations
Australia
John Hunter Children's Hospital
Recruiting
Hunter Regional Mail Centre
Women's and Children's Hospital-Adelaide
Active, not recruiting
North Adelaide
Royal Children's Hospital
Suspended
Parkville
Perth Children's Hospital
Recruiting
Perth
Sydney Children's Hospital
Recruiting
Randwick
Queensland Children's Hospital
Recruiting
South Brisbane
The Children's Hospital at Westmead
Recruiting
Westmead
Canada
Alberta Children's Hospital
Recruiting
Calgary
University of Alberta Hospital
Recruiting
Edmonton
IWK Health Centre
Recruiting
Halifax
McMaster Children's Hospital at Hamilton Health Sciences
Recruiting
Hamilton
Kingston Health Sciences Centre
Recruiting
Kingston
Children's Hospital
Recruiting
London
Centre Hospitalier Universitaire Sainte-Justine
Recruiting
Montreal
The Montreal Children's Hospital of the MUHC
Recruiting
Montreal
Centre Hospitalier Universitaire de Quebec
Recruiting
Quebec
Jim Pattison Children's Hospital
Recruiting
Saskatoon
Saskatoon Cancer Centre
Suspended
Saskatoon
Hospital for Sick Children
Recruiting
Toronto
CancerCare Manitoba
Recruiting
Winnipeg
New Zealand
Christchurch Hospital
Recruiting
Christchurch
Starship Children's Hospital
Recruiting
Grafton
Puerto Rico
San Jorge Children's Hospital
Active, not recruiting
San Juan
University Pediatric Hospital
Recruiting
San Juan
Saudi Arabia
King Faisal Specialist Hospital and Research Centre
Recruiting
Riyadh
Time Frame
Start Date: May 23, 2018
Estimated Completion Date: June 30, 2025
Participants
Target number of participants: 537
Treatments
Active Comparator: Group A1 (WDF)
Patients undergo observation.
Experimental: GROUP A2 (NON-WDF)
Patients receive cisplatin IV over 6 hours on day 1 following surgery. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Experimental: GROUP B1 ARM 4-CDDP
Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for 4 cycles (2 pre-surgery, 2 post-surgery) in the absence of disease progression or unacceptable toxicity.
Experimental: GROUP B1 ARM 6-CDDP
Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for 6 cycles (2 pre-surgery, 4 post-surgery) in the absence of disease progression or unacceptable toxicity.
Experimental: GROUP B2 ARM I
Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for up to 6 total cycles (4 pre-surgery, 2 post-surgery). After cycle 4, patients undergo surgery, then continue with 2 additional cycles of cisplatin.
Experimental: GROUP B2 ARM II
Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for up to 6 total cycles.
Experimental: GROUP C ARM C5VD
Patients receive cisplatin IV over 6 hours on day 1, 5-fluorouracil IV over 1-15 minutes, vincristine sulfate IV over 1 minute on days 1, 8, and 15 and doxorubicin IV over 1-15 minutes on days 1 and 2. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after cycle 2 or 4.
Experimental: GROUP C ARM CDDP
Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after cycle 2 or 4.
Experimental: GROUP D1
SIOPEL-4 INDUCTION: Patients receive cisplatin IV over 6 hours on days 1, 8, and 15 (for cycles 1 and 2) and days 1 and 8 (for cycle 3) and doxorubicin IV over 1-15 minutes on days 8 and 9 during cycles 1 and 2 and days 1 and 2 during cycle 3. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION: Patients with lung complete remission (either with chemotherapy and/or surgery) receive carboplatin IV over 1 hour on day 1 and doxorubicin IV over 1-15 minutes on days 1 and 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Experimental: GROUP D2 ARM CE
SIOPEL-4 IV INDUCTION: Patients receive cisplatin IV over 6 hours on days 1, 8, and 15 (for cycles 1 and 2) and days 1 and 8 (for cycle 3) and doxorubicin IV over 1-15 minutes on days 8 and 9. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.~Patients receive carboplatin IV over 1 hour on days 1 and 2, doxorubicin IV over 1-15 minutes on days 1 and 2 during cycles 1, 3 and 5, and carboplatin over 1 hour and etoposide IV over 2 hours on day 1 and 2 of cycles 2, 4 and 6. Treatments repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Experimental: GROUP D2 ARM VI
SIOPEL-4 IV INDUCTION: Patients receive cisplatin IV over 6 hours on days 1, 8, and 15 (for cycles 1 and 2) and days 1 and 8 (for cycle 3) and doxorubicin IV over 1-15 minutes on days 8 and 9. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.~Patients receive carboplatin IV over 1 hour on days 1 and 2 and doxorubicin IV over 1-15 minutes on days 1 and 2 during cycles 1, 3 and 5. Patients also receive vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan IV over 90 minutes QD on days 1 to 5 of cycles 2, 4 and 6. Treatments repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Active Comparator: GROUP E1
Patients undergo observation only.
Experimental: GROUP E2 (PLADO)
Patients receive cisplatin IV over 6 hours on day 1 and doxorubicin IV over 1-15 minutes on days 1 and 2 following surgery. Treatments repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
Experimental: GROUP F ARM 1 (PLADO)
Patients receive cisplatin IV over 6 hours on day 1, doxorubicin IV over 1-15 minutes on days 1 and 2 and sorafenib PO BID on days 3-21. Treatments repeat every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo surgery, if tumors are resectable, or receive an additional 3 cycles of the treatment.
Experimental: GROUP F ARM 2 (P/GEMOX)
Patients receive cisplatin IV over 6 hours on day 1, doxorubicin IV over 1-15 minutes on days 1 and 2 and sorafenib PO BID on days 3-14 of cycles 1 and 3. Patients also receive gemcitabine IV over 90 minutes on day 1, oxaliplatin IV over 2 hours on day 1 and sorafenib PO on days 1-14 of cycles 2 and 4. Patients may undergo surgery, if tumors are resectable, or receive an additional 4 cycles of the treatment.
Authors
Craig Erker, Valeria Smith, Lisa L. Hartman, John F. Kuttesch, Alok K. Kothari, Carola A. Arndt, Elyssa M. Rubin, Robin Y. Dulman, Haydar A. Frangoul, Frederick S. Huang, Ashley E. Meyer, Nina S. Kadan-Lottick, Alissa Kahn, Eric C. Larsen, Sarah B. Whittle, Kathryn L. Laurie, Marcio H. Malogolowkin, Jessica C. Hochberg, Emily Blauel, Allison F. O'Neill, Douglas S. Hawkins, Mary L. Schmidt, Eduard H. Panosyan, Vinod K. Gidvani-Diaz, Julio C. Barredo, Afshan A. Ali, Vlad C. Radulescu, Matthew A. Kutny, Eric J. Lowe, Gary D. Crouch, Nadine P. SantaCruz, Mariko Sato, Ashok B. Raj, Frances Austin, Alissa M. Martin, Jessica M. Valdez, Jessica Boklan, Keith J. August, Kishor M. Bhende, Lisa Gennarini, Stanton C. Goldman, Thomas W. McLean, Michael S. Isakoff, John J. Letterio, Justine M. Kahn, Kayelyn J. Wagner, Ziad A. Khatib, Mukund G. Dole, Michael J. Kelly, David L. Becton, Laura E. Agresta, Adit L. Tal, Lars M. Wagner, Phillip E. Barnette, Matthew Dietz, Rabi Hanna, Hardeo K. Panchoosingh, Timothy C. Griffin, Katrina Winsnes, Robin D. Hanson, Vonda L. Crouse, Scott C. Borinstein, Elizabeth Fox, Ranjan Bista, Jennifer A. Domm, Don E. Eslin, William B. Slayton, Lolie C. Yu, Kamnesh R. Pradhan, Lauren J. Akers, Kathryn S. Sutton, Iftikhar Hanif, Aron Flagg, Mark A. Ranalli, David S. Dickens, Pooja Hingorani, Erin K. Barr, William C. Petersen, Leo Mascarenhas, Erin Wright, Jamie M. Aye, Ray C. Pais, Laura E. Hogan, Jamie L. Dargart, Sheri L. Spunt, Adonis N. Lorenzana, Jason Law, Duncan S. Stearns, Andrew L. Pendleton, Barbara A. Gruner, Yoko T. Udaka, Jose M. Esquilin, Rajen Mody, Aarati V. Rao, Joseph C. Torkildson, Linda C. Stork, Michelle A. Manalang, Clare J. Twist, Craig Lotterman, Erlyn C. Smith, Aniket Saha, Maria E. Echevarria, Colleen H. McDonough, Noah C. Federman, Eugenia Chang, Sandeep Batra, Aghiad Chamdin, Gregory M. Tiao, Emily G. Greengard, Thomas B. Russell, Victor A. Lewis, Richard A. Drachtman, Nicholas W. McGregor, James T. Badgett, Robert G. Irwin, Carla B. Golden, Susan E. Spiller, Douglas J. Scothorn, Carrye R. Cost, Eugene Suh, Ami V. Desai, Jonathan L. Metts, Joanna G. Luty, Fouad M. Hajjar, Judy L. Felgenhauer, Jacob A. Troutman, Suzanne P. MacFarland, Minnie Abromowitch, Wade T. Kyono, Amy A. Smith, William D. Roberts, Laura Sedig, Bethany M. Mikles, Gregory P. Brandt, William S. Ferguson, Marshall A. Schorin, Alan D. Friedman, Lisa M. McGregor, Robert M. Cooper, Robert E. Goldsby, Nichole L. Bryant, Santosh S. Hanmod, Wendy L. Woods-Swafford, Susan G. Kreissman, Brian S. Greffe, Sara Chaffee, Laura A. Campbell, Jennifer J. Welch, Jagadeesh Ramdas, Philip M. Monteleone, Stuart L. Cramer, Jeffrey A. Toretsky, Jay Michael S. Balagtas, Joel A. Kaplan, Daniel J. Benedetti, Gregory E. Halligan, Brenda J. Wittman, Yung S. Yim, Katharine Offer, Alan K. Ikeda, Samantha L. Mallory, Enrique A. Escalon, Dana A. Obzut, Nkechi I. Mba, Amy L. Walz, Janice F. Olson, Laura K. Gowans, Louis B. Rapkin, Rebecca E. McFall, Narayana Gowda, Michael K. Richards, Wayne L. Furman, Steven J. Kuerbitz, Meghen B. Browning, James I. Geller, Alice Lee, Lauren R. Weintraub, Jeffrey H. Schwartz, Jason M. Fixler, Sharon L. Gardner, Jill C. Beck, Jonathan E. Wickiser, Jennifer J. Clark, Julie Kim, Jessica A. Bell, Frank M. Balis, Teena Bhatla, Teresa A. York, Jessica L. Heath, Albert Kheradpour, Jeffrey S. Dome, Melissa A. Forouhar, Mohamad H. Badawi, Pillai Pallavi Madhusoodhan, Jessica Gartrell, Farzana Pashankar, John J. Gregory, Arun A. Rangaswami, Emad K. Salman, Stuart H. Gold, Amy C. Fowler, Luis A. Clavell, Douglas R. Strother, Kenneth B. De Santes, Felipe S. Bautista-Otanez, Stephan R. Paul, Christopher Mpofu, Elizabeth L. Hesketh, Michael V. Ortiz, Karen S. Fernandez, Rebecca O. Clark, Jennifer L. Mayer, Jacqueline N. Casillas, Kathleen Felton, Ashley Chopek, Sharon B. Abish, Carolyn F. Levy, Amanda J. Lyver, Mark A. Winstanley, Laura Wheaton, Ayman A. El-Sheikh, Yvan Samson, Anne-Marie R. Langevin, Pedro A. De Alarcon, Shannon M. Cohn, Najat C. Daw, Kenneth B. DeSantes, Uma H. Athale, Jacqueline M. Kraveka, Jennifer J. Greene Welch, Shayna M. Zelcer, Rene Y. McNall-Knapp, Bhavna Padhye, Furqan Shaikh, David E. Kram, Kathleen J. Yost, Jaime M. Libes, Marianne B. Phillips, Draga Barbaric, Helen Irving, Mohamad M. Al-Rahawan, Mariana P. Silva, Sarah J. McKillop, Ramamoorthy Nagasubramanian, Sarah E. Leary, Anderson (Andy) B. Collier, Bruno Michon, Conrad V. Fernandez, Kenneth Lieuw
Sponsors
Leads: Children's Oncology Group
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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