Phase II/III Second-Line NABPLAGEM vs. Nab-Paclitaxel/Gemcitabine in BRCA1/2 or PALB2 Mutant Metastatic Pancreatic Ductal Adenocarcinoma (PLATINUM)

Status: Recruiting
Location: See all (344) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

This phase II/III trial compares the effect of the 3-drug chemotherapy combination of nab-paclitaxel, gemcitabine, plus cisplatin versus the 2-drug chemotherapy combination of nab-paclitaxel plus gemcitabine for the treatment of patients with pancreatic cancer that has spread to other places in the body (metastatic) and a known genetic mutation in the BRCA1, BRCA2, or PALB2 gene.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Metastatic pancreatic adenocarcinoma. Adenosquamous carcinoma, squamous carcinoma, acinar cell carcinoma, and carcinoma not otherwise specified are also acceptable

• BRCA1/2 or PALB2 mutation (somatic or germline) identified on any Clinical Laboratory Improvement Amendments (CLIA)-certified gene panel. Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org. (Submission of mutation report will be required)

• Measurable disease

• Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment

• Clinical or radiographic progression on first-line FOLFIRINOX (or nanoliposomal irinotecan, fluorouracil, leucovorin, and oxaliplatin \[NALIRIFOX\]) for metastatic disease

‣ Patients whose front-line chemotherapy was required to be simplified due to toxicity associated with any of the constituent components of FOLFIRINOX/NALIRIFOX (e.g. simplified to leucovorin calcium, fluorouracil, and oxaliplatin \[FOLFOX\], leucovorin calcium, fluorouracil, and irinotecan \[FOLFIRI\], fluorouracil \[5-FU\] \[including capecitabine\]) will be eligible

⁃ Patients with progressive disease while on maintenance PARP inhibitor treatment after FOLFIRINOX (or NALIRIFOX), irrespective of how long ago they received FOLFIRINOX/NALIRIFOX, will also be eligible

⁃ Patients who develop metastatic disease during or within 6 months after completing FOLFIRINOX/NALIRIFOX in either the locally advanced or adjuvant/neoadjuvant settings will be eligible

• Patients may not have received prior cisplatin for their pancreatic cancer in any setting

• \* Note: Patients may have previously received gemcitabine +/- nab-paclitaxel for resectable (neoadjuvant/adjuvant) or locally advanced disease if (1) treatment was completed \> 1 year ago and (2) in the opinion of the treating provider, re-treatment with gemcitabine/nab-paclitaxel is appropriate

• Age \>= 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky performance status \>= 60)

• Absolute neutrophil count \>= 1,500/mm\^3

• Platelet count \>= 100,000/mm\^3

• Hemoglobin \>= 8.0 g/dL

• Creatinine =\< 1.8 x institutional upper limit of normal (ULN) or calculated creatinine clearance (Calc. CrCl) \> 40 mL/min

• Total bilirubin =\< 2.0 x institutional ULN

• \* Any elevated bilirubin should be asymptomatic at enrollment (except for participants with documented Gilbert's syndrome who may only be included if the total bilirubin =\< 3 x ULN or direct bilirubin =\< 1.5 x ULN)

• Aspartate transaminase (AST)/alanine transaminase (ALT) =\< 3 x institutional ULN

• \* AST/ALT of =\< 5 x ULN if liver metastases are present

• Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects

• \* Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required

• Patients with \> grade 2 peripheral sensory neuropathy are not eligible

• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

• Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 8-weeks.

• \* Patients with known, new or progressive brain metastases (active brain metastases) or leptomeningeal disease are ineligible

• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load anytime within 6 months prior to registration are eligible for this trial

• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

• \* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

• Concomitant chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study

• Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
RECRUITING
Anchorage
Alaska Oncology and Hematology LLC
RECRUITING
Anchorage
Alaska Women's Cancer Care
RECRUITING
Anchorage
Anchorage Associates in Radiation Medicine
RECRUITING
Anchorage
Anchorage Oncology Centre
SUSPENDED
Anchorage
Anchorage Radiation Therapy Center
SUSPENDED
Anchorage
Katmai Oncology Group
RECRUITING
Anchorage
Providence Alaska Medical Center
RECRUITING
Anchorage
Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
RECRUITING
Jonesboro
Arizona
CTCA at Western Regional Medical Center
RECRUITING
Goodyear
Cancer Center at Saint Joseph's
ACTIVE_NOT_RECRUITING
Phoenix
California
Mission Hope Medical Oncology - Arroyo Grande
ACTIVE_NOT_RECRUITING
Arroyo Grande
Providence Saint Joseph Medical Center/Disney Family Cancer Center
RECRUITING
Burbank
Mercy Cancer Center - Carmichael
ACTIVE_NOT_RECRUITING
Carmichael
Mercy San Juan Medical Center
ACTIVE_NOT_RECRUITING
Carmichael
Mercy Cancer Center - Elk Grove
ACTIVE_NOT_RECRUITING
Elk Grove
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITING
Irvine
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
UCI Health Laguna Hills
ACTIVE_NOT_RECRUITING
Laguna Hills
Mercy Cancer Center
ACTIVE_NOT_RECRUITING
Merced
Providence Queen of The Valley
RECRUITING
Napa
UC Irvine Health/Chao Family Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING
Orange
Mercy Cancer Center - Rocklin
ACTIVE_NOT_RECRUITING
Rocklin
Mercy Cancer Center - Sacramento
ACTIVE_NOT_RECRUITING
Sacramento
UC San Diego Medical Center - Hillcrest
RECRUITING
San Diego
UCSF Medical Center-Mission Bay
RECRUITING
San Francisco
Pacific Central Coast Health Center-San Luis Obispo
ACTIVE_NOT_RECRUITING
San Luis Obispo
Mission Hope Medical Oncology - Santa Maria
ACTIVE_NOT_RECRUITING
Santa Maria
Providence Medical Foundation - Santa Rosa
RECRUITING
Santa Rosa
Providence Santa Rosa Memorial Hospital
RECRUITING
Santa Rosa
Saint Joseph's Medical Center
ACTIVE_NOT_RECRUITING
Stockton
Woodland Memorial Hospital
ACTIVE_NOT_RECRUITING
Woodland
Colorado
Penrose-Saint Francis Healthcare
ACTIVE_NOT_RECRUITING
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
ACTIVE_NOT_RECRUITING
Colorado Springs
Saint Francis Cancer Center
ACTIVE_NOT_RECRUITING
Colorado Springs
CommonSpirit Cancer Center Mercy
ACTIVE_NOT_RECRUITING
Durango
Mercy Medical Center
ACTIVE_NOT_RECRUITING
Durango
Saint Anthony Hospital
ACTIVE_NOT_RECRUITING
Lakewood
Longmont United Hospital
ACTIVE_NOT_RECRUITING
Longmont
Saint Mary Corwin Medical Center
ACTIVE_NOT_RECRUITING
Pueblo
Saint Anthony North Hospital
ACTIVE_NOT_RECRUITING
Westminster
Florida
Mount Sinai Comprehensive Cancer Center at Aventura
RECRUITING
Aventura
Mount Sinai Medical Center
RECRUITING
Miami Beach
Georgia
University Cancer and Blood Center LLC
RECRUITING
Athens
Hawaii
Hawaii Cancer Care - Westridge
RECRUITING
‘aiea
Pali Momi Medical Center
RECRUITING
‘aiea
Queen's Cancer Center - Pearlridge
RECRUITING
‘aiea
The Cancer Center of Hawaii-Pali Momi
RECRUITING
‘aiea
The Queen's Medical Center - West Oahu
RECRUITING
‘ewa Beach
Hawaii Cancer Care Inc - Waterfront Plaza
RECRUITING
Honolulu
Hawaii Diagnostic Radiology Services LLC
RECRUITING
Honolulu
Kapiolani Medical Center for Women and Children
RECRUITING
Honolulu
Kuakini Medical Center
RECRUITING
Honolulu
Queen's Cancer Cenrer - POB I
RECRUITING
Honolulu
Queen's Cancer Center - Kuakini
RECRUITING
Honolulu
Queen's Medical Center
RECRUITING
Honolulu
Straub Clinic and Hospital
RECRUITING
Honolulu
The Cancer Center of Hawaii-Liliha
RECRUITING
Honolulu
University of Hawaii Cancer Center
RECRUITING
Honolulu
Straub Medical Center - Kahului Clinic
RECRUITING
Kahului
Castle Medical Center
SUSPENDED
Kailua
Wilcox Memorial Hospital and Kauai Medical Clinic
RECRUITING
Lihue
Iowa
Mary Greeley Medical Center
RECRUITING
Ames
McFarland Clinic - Ames
RECRUITING
Ames
UI Health Care Mission Cancer and Blood - Ankeny Clinic
RECRUITING
Ankeny
McFarland Clinic - Boone
RECRUITING
Boone
Mercy Hospital
RECRUITING
Cedar Rapids
Oncology Associates at Mercy Medical Center
RECRUITING
Cedar Rapids
Mercy Cancer Center-West Lakes
RECRUITING
Clive
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
RECRUITING
Clive
Alegent Health Mercy Hospital
ACTIVE_NOT_RECRUITING
Council Bluffs
Heartland Oncology and Hematology LLP
RECRUITING
Council Bluffs
Methodist Jennie Edmundson Hospital
RECRUITING
Council Bluffs
Greater Regional Medical Center
RECRUITING
Creston
Iowa Methodist Medical Center
RECRUITING
Des Moines
Mercy Medical Center - Des Moines
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic
RECRUITING
Des Moines
McFarland Clinic - Trinity Cancer Center
RECRUITING
Fort Dodge
McFarland Clinic - Jefferson
RECRUITING
Jefferson
McFarland Clinic - Marshalltown
RECRUITING
Marshalltown
UI Health Care Mission Cancer and Blood - Waukee Clinic
RECRUITING
Waukee
Mercy Medical Center-West Lakes
RECRUITING
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Boise
SUSPENDED
Boise
Saint Luke's Cancer Institute - Boise
RECRUITING
Boise
Saint Alphonsus Cancer Care Center-Caldwell
SUSPENDED
Caldwell
Kootenai Health - Coeur d'Alene
RECRUITING
Coeur D'alene
Walter Knox Memorial Hospital
SUSPENDED
Emmett
Saint Luke's Cancer Institute - Fruitland
RECRUITING
Fruitland
Idaho Urologic Institute-Meridian
SUSPENDED
Meridian
Saint Luke's Cancer Institute - Meridian
RECRUITING
Meridian
Saint Alphonsus Cancer Care Center-Nampa
SUSPENDED
Nampa
Saint Luke's Cancer Institute - Nampa
RECRUITING
Nampa
Kootenai Clinic Cancer Services - Post Falls
RECRUITING
Post Falls
Kootenai Clinic Cancer Services - Sandpoint
RECRUITING
Sandpoint
Saint Luke's Cancer Institute - Twin Falls
RECRUITING
Twin Falls
Illinois
Rush-Copley Medical Center
RECRUITING
Aurora
Illinois CancerCare-Bloomington
RECRUITING
Bloomington
Illinois CancerCare-Canton
RECRUITING
Canton
Memorial Hospital of Carbondale
RECRUITING
Carbondale
SIH Cancer Institute
RECRUITING
Carterville
Illinois CancerCare-Carthage
RECRUITING
Carthage
Centralia Oncology Clinic
RECRUITING
Centralia
Northwestern University
RECRUITING
Chicago
University of Chicago Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING
Chicago
University of Illinois
RECRUITING
Chicago
Carle at The Riverfront
RECRUITING
Danville
Cancer Care Specialists of Illinois - Decatur
RECRUITING
Decatur
Decatur Memorial Hospital
RECRUITING
Decatur
Northwestern Medicine Cancer Center Kishwaukee
RECRUITING
Dekalb
Illinois CancerCare-Dixon
RECRUITING
Dixon
Carle Physician Group-Effingham
RECRUITING
Effingham
Crossroads Cancer Center
RECRUITING
Effingham
Illinois CancerCare-Eureka
RECRUITING
Eureka
Illinois CancerCare-Galesburg
RECRUITING
Galesburg
Western Illinois Cancer Treatment Center
SUSPENDED
Galesburg
Northwestern Medicine Cancer Center Delnor
RECRUITING
Geneva
Northwestern Medicine Glenview Outpatient Center
RECRUITING
Glenview
Northwestern Medicine Grayslake Outpatient Center
RECRUITING
Grayslake
Ingalls Memorial Hospital
ACTIVE_NOT_RECRUITING
Harvey
Illinois CancerCare-Kewanee Clinic
RECRUITING
Kewanee
Northwestern Medicine Lake Forest Hospital
RECRUITING
Lake Forest
Illinois CancerCare-Macomb
RECRUITING
Macomb
Carle Physician Group-Mattoon/Charleston
RECRUITING
Mattoon
UC Comprehensive Cancer Center at Silver Cross
ACTIVE_NOT_RECRUITING
New Lenox
Cancer Care Center of O'Fallon
RECRUITING
O'fallon
HSHS Saint Elizabeth's Hospital
RECRUITING
O'fallon
Northwestern Medicine Oak Brook
RECRUITING
Oak Brook
Northwestern Medicine Orland Park
RECRUITING
Orland Park
University of Chicago Medicine-Orland Park
ACTIVE_NOT_RECRUITING
Orland Park
Illinois CancerCare-Ottawa Clinic
RECRUITING
Ottawa
Illinois CancerCare-Pekin
RECRUITING
Pekin
Illinois CancerCare-Peoria
RECRUITING
Peoria
Methodist Medical Center of Illinois
RECRUITING
Peoria
Illinois CancerCare-Peru
RECRUITING
Peru
Valley Radiation Oncology
RECRUITING
Peru
Illinois CancerCare-Princeton
RECRUITING
Princeton
Southern Illinois University School of Medicine
RECRUITING
Springfield
Springfield Clinic
RECRUITING
Springfield
Springfield Memorial Hospital
RECRUITING
Springfield
Carle Cancer Center
RECRUITING
Urbana
Northwestern Medicine Cancer Center Warrenville
RECRUITING
Warrenville
Illinois CancerCare - Washington
RECRUITING
Washington
Rush-Copley Healthcare Center
RECRUITING
Yorkville
Indiana
Northwest Cancer Center - Main Campus
RECRUITING
Crown Point
UChicago Medicine Northwest Indiana
ACTIVE_NOT_RECRUITING
Crown Point
Northwest Oncology LLC
RECRUITING
Dyer
Northwest Cancer Center - Hobart
RECRUITING
Hobart
Saint Mary Medical Center
RECRUITING
Hobart
Saint Catherine Hospital
RECRUITING
Indianapolis
The Community Hospital
RECRUITING
Munster
Women's Diagnostic Center - Munster
RECRUITING
Munster
Northwest Cancer Center - Valparaiso
RECRUITING
Valparaiso
Kentucky
Flaget Memorial Hospital
ACTIVE_NOT_RECRUITING
Bardstown
Commonwealth Cancer Center-Corbin
ACTIVE_NOT_RECRUITING
Corbin
Saint Joseph Hospital
ACTIVE_NOT_RECRUITING
Lexington
Saint Joseph Hospital East
ACTIVE_NOT_RECRUITING
Lexington
Saint Joseph Radiation Oncology Resource Center
ACTIVE_NOT_RECRUITING
Lexington
Saint Joseph London
ACTIVE_NOT_RECRUITING
London
Saint Joseph Mount Sterling
ACTIVE_NOT_RECRUITING
Mount Sterling
Michigan
Hickman Cancer Center
SUSPENDED
Adrian
University of Michigan Comprehensive Cancer Center
RECRUITING
Ann Arbor
Bronson Battle Creek
RECRUITING
Battle Creek
University of Michigan - Brighton Center for Specialty Care
RECRUITING
Brighton
Henry Ford Cancer Institute-Downriver
RECRUITING
Brownstown
Henry Ford Macomb Hospital-Clinton Township
RECRUITING
Clinton Township
Henry Ford Medical Center-Fairlane
RECRUITING
Dearborn
Henry Ford Hospital
RECRUITING
Detroit
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
RECRUITING
Grand Rapids
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
RECRUITING
Grand Rapids
Trinity Health Grand Rapids Hospital
RECRUITING
Grand Rapids
Allegiance Health
RECRUITING
Jackson
Beacon Kalamazoo
RECRUITING
Kalamazoo
Beacon Kalamazoo Cancer Center
RECRUITING
Kalamazoo
Bronson Methodist Hospital
RECRUITING
Kalamazoo
West Michigan Cancer Center
RECRUITING
Kalamazoo
Toledo Clinic Cancer Centers-Monroe
SUSPENDED
Monroe
Trinity Health Muskegon Hospital
RECRUITING
Muskegon
Corewell Health Lakeland Hospitals - Niles Hospital
RECRUITING
Niles
Cancer and Hematology Centers of Western Michigan - Norton Shores
RECRUITING
Norton Shores
Henry Ford Medical Center-Columbus
RECRUITING
Novi
Corewell Health Reed City Hospital
RECRUITING
Reed City
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
RECRUITING
Saint Joseph
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
RECRUITING
Saint Joseph
Munson Medical Center
RECRUITING
Traverse City
Henry Ford West Bloomfield Hospital
RECRUITING
West Bloomfield
Henry Ford Wyandotte Hospital
RECRUITING
Wyandotte
University of Michigan Health - West
RECRUITING
Wyoming
Minnesota
Riverwood Healthcare Center
RECRUITING
Aitkin
Essentia Health - Baxter Clinic
RECRUITING
Baxter
Essentia Health Saint Joseph's Medical Center
RECRUITING
Brainerd
Minnesota Oncology - Burnsville
RECRUITING
Burnsville
Cambridge Medical Center
RECRUITING
Cambridge
Mercy Hospital
RECRUITING
Coon Rapids
Essentia Health - Saint Joseph's Crosslake Clinic
RECRUITING
Crosslake
Essentia Health - Deer River Clinic
RECRUITING
Deer River
Essentia Health Saint Mary's - Detroit Lakes Clinic
RECRUITING
Detroit Lakes
Essentia Health Cancer Center
RECRUITING
Duluth
Essentia Health Saint Mary's Medical Center
RECRUITING
Duluth
Miller-Dwan Hospital
RECRUITING
Duluth
Fairview Southdale Hospital
RECRUITING
Edina
Essentia Health - Ely Clinic
RECRUITING
Ely
Essentia Health - Fosston
RECRUITING
Fosston
Essentia Health Hibbing Clinic
RECRUITING
Hibbing
Essentia Health - International Falls Clinic
RECRUITING
International Falls
Fairview Clinics and Surgery Center Maple Grove
RECRUITING
Maple Grove
Minnesota Oncology Hematology PA-Maplewood
RECRUITING
Maplewood
Saint John's Hospital - Healtheast
RECRUITING
Maplewood
Abbott-Northwestern Hospital
RECRUITING
Minneapolis
Health Partners Inc
RECRUITING
Minneapolis
Hennepin County Medical Center
RECRUITING
Minneapolis
Monticello Cancer Center
RECRUITING
Monticello
Essentia Health - Moose Lake Clinic
RECRUITING
Moose Lake
New Ulm Medical Center
RECRUITING
New Ulm
Essentia Health - Park Rapids
RECRUITING
Park Rapids
Essentia Health - Saint Joseph's Pequot Lakes Clinic
RECRUITING
Pequot Lakes
Essentia Health - Saint Joseph's Pine River Clinic
RECRUITING
Pine River
Fairview Northland Medical Center
RECRUITING
Princeton
North Memorial Medical Health Center
RECRUITING
Robbinsdale
Coborn Cancer Center at Saint Cloud Hospital
RECRUITING
Saint Cloud
Park Nicollet Clinic - Saint Louis Park
RECRUITING
Saint Louis Park
Regions Hospital
RECRUITING
Saint Paul
United Hospital
RECRUITING
Saint Paul
Essentia Health Sandstone
RECRUITING
Sandstone
Saint Francis Regional Medical Center
RECRUITING
Shakopee
Essentia Health - Saint Joseph's Staples Clinic
RECRUITING
Staples
Lakeview Hospital
RECRUITING
Stillwater
Essentia Health Virginia Clinic
RECRUITING
Virginia
Ridgeview Medical Center
RECRUITING
Waconia
Rice Memorial Hospital
RECRUITING
Willmar
Minnesota Oncology Hematology PA-Woodbury
RECRUITING
Woodbury
Fairview Lakes Medical Center
RECRUITING
Wyoming
Missouri
Mercy Cancer Center - Cape Girardeau
SUSPENDED
Cape Girardeau
Saint Francis Medical Center
RECRUITING
Cape Girardeau
Parkland Health Center - Farmington
RECRUITING
Farmington
Sainte Genevieve County Memorial Hospital
RECRUITING
Sainte Genevieve
Missouri Baptist Medical Center
RECRUITING
St Louis
Missouri Baptist Sullivan Hospital
RECRUITING
Sullivan
BJC Outpatient Center at Sunset Hills
RECRUITING
Sunset Hills
Mississippi
Baptist Memorial Hospital and Cancer Center-Golden Triangle
RECRUITING
Columbus
Baptist Cancer Center-Grenada
RECRUITING
Grenada
Baptist Memorial Hospital and Cancer Center-Union County
RECRUITING
New Albany
Baptist Memorial Hospital and Cancer Center-Oxford
RECRUITING
Oxford
Baptist Memorial Hospital and Cancer Center-Desoto
RECRUITING
Southhaven
Montana
Community Hospital of Anaconda
RECRUITING
Anaconda
Billings Clinic Cancer Center
RECRUITING
Billings
Bozeman Health Deaconess Hospital
RECRUITING
Bozeman
Benefis Sletten Cancer Institute
RECRUITING
Great Falls
Great Falls Clinic
RECRUITING
Great Falls
Hi-Line Sletten Cancer Center
RECRUITING
Havre
Logan Health Medical Center
RECRUITING
Kalispell
Community Medical Center
RECRUITING
Missoula
Saint Patrick Hospital - Community Hospital
RECRUITING
Missoula
North Dakota
Essentia Health Cancer Center-South University Clinic
RECRUITING
Fargo
Essentia Health - Jamestown Clinic
RECRUITING
Jamestown
Nebraska
CHI Health Saint Francis
ACTIVE_NOT_RECRUITING
Grand Island
CHI Health Good Samaritan
ACTIVE_NOT_RECRUITING
Kearney
Saint Elizabeth Regional Medical Center
ACTIVE_NOT_RECRUITING
Lincoln
Alegent Health Bergan Mercy Medical Center
ACTIVE_NOT_RECRUITING
Omaha
Alegent Health Immanuel Medical Center
ACTIVE_NOT_RECRUITING
Omaha
Alegent Health Lakeside Hospital
ACTIVE_NOT_RECRUITING
Omaha
Creighton University Medical Center
ACTIVE_NOT_RECRUITING
Omaha
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
RECRUITING
Omaha
Nebraska Methodist Hospital
RECRUITING
Omaha
Oncology Associates PC
SUSPENDED
Omaha
Midlands Community Hospital
ACTIVE_NOT_RECRUITING
Papillion
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITING
Lebanon
Dartmouth Cancer Center - Nashua
RECRUITING
Nashua
New Mexico
University of New Mexico Cancer Center
RECRUITING
Albuquerque
New York
Glens Falls Hospital
RECRUITING
Glens Falls
NYU Langone Hospital - Long Island
RECRUITING
Mineola
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING
New York
Ohio
Bethesda North Hospital
ACTIVE_NOT_RECRUITING
Cincinnati
Good Samaritan Hospital - Cincinnati
ACTIVE_NOT_RECRUITING
Cincinnati
TriHealth Cancer Institute-Anderson
ACTIVE_NOT_RECRUITING
Cincinnati
TriHealth Cancer Institute-Westside
ACTIVE_NOT_RECRUITING
Cincinnati
Toledo Clinic Cancer Centers-Maumee
SUSPENDED
Maumee
Toledo Clinic Cancer Centers-Toledo
SUSPENDED
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oklahoma Cancer Specialists and Research Institute-Tulsa
ACTIVE_NOT_RECRUITING
Tulsa
Oregon
Saint Alphonsus Cancer Care Center-Baker City
SUSPENDED
Baker City
Saint Charles Health System
RECRUITING
Bend
Clackamas Radiation Oncology Center
RECRUITING
Clackamas
Providence Cancer Institute Clackamas Clinic
SUSPENDED
Clackamas
Bay Area Hospital
RECRUITING
Coos Bay
Providence Hood River Memorial Hospital
RECRUITING
Hood River
Providence Newberg Medical Center
RECRUITING
Newberg
Saint Alphonsus Cancer Care Center-Ontario
SUSPENDED
Ontario
Providence Willamette Falls Medical Center
RECRUITING
Oregon City
Providence Portland Medical Center
RECRUITING
Portland
Providence Saint Vincent Medical Center
RECRUITING
Portland
Saint Charles Health System-Redmond
RECRUITING
Redmond
South Carolina
Bon Secours Saint Francis Hospital
RECRUITING
Charleston
Charleston Oncology - Roper
RECRUITING
Charleston
Charleston Oncology - Saint Francis
RECRUITING
Charleston
Roper Hospital
RECRUITING
Charleston
Tennessee
Baptist Memorial Hospital and Cancer Center-Collierville
RECRUITING
Collierville
Baptist Memorial Hospital and Cancer Center-Memphis
RECRUITING
Memphis
Texas
Parkland Memorial Hospital
RECRUITING
Dallas
UT Southwestern Simmons Cancer Center - RedBird
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth
RECRUITING
Fort Worth
UT Southwestern Clinical Center at Richardson/Plano
RECRUITING
Richardson
Virginia
Inova Fair Oaks Hospital
RECRUITING
Fairfax
Inova Schar Cancer Institute
RECRUITING
Fairfax
Inova Fairfax Hospital
RECRUITING
Falls Church
Vermont
Dartmouth Cancer Center - North
RECRUITING
Saint Johnsbury
Washington
Providence Regional Cancer System-Aberdeen
RECRUITING
Aberdeen
PeaceHealth Saint Joseph Medical Center
RECRUITING
Bellingham
Providence Regional Cancer System-Centralia
RECRUITING
Centralia
Swedish Cancer Institute-Edmonds
RECRUITING
Edmonds
Providence Regional Cancer Partnership
RECRUITING
Everett
Swedish Cancer Institute-Issaquah
RECRUITING
Issaquah
Kadlec Clinic Hematology and Oncology
RECRUITING
Kennewick
Providence Regional Cancer System-Lacey
RECRUITING
Lacey
PeaceHealth Saint John Medical Center
RECRUITING
Longview
Skagit Regional Health Cancer Care Center
RECRUITING
Mount Vernon
Swedish Medical Center-Ballard Campus
RECRUITING
Seattle
Swedish Medical Center-Cherry Hill
RECRUITING
Seattle
Swedish Medical Center-First Hill
RECRUITING
Seattle
PeaceHealth United General Medical Center
RECRUITING
Sedro-woolley
Providence Regional Cancer System-Shelton
SUSPENDED
Shelton
Saint Michael Cancer Center
ACTIVE_NOT_RECRUITING
Silverdale
Cancer Care Northwest - Spokane South
RECRUITING
Spokane
Cancer Care Northwest-North Spokane
RECRUITING
Spokane
Cancer Care Northwest-Valley
RECRUITING
Spokane
PeaceHealth Southwest Medical Center
RECRUITING
Vancouver
Providence Saint Mary Regional Cancer Center
RECRUITING
Walla Walla
Providence Regional Cancer System-Yelm
SUSPENDED
Yelm
Wisconsin
Duluth Clinic Ashland
RECRUITING
Ashland
Northwest Wisconsin Cancer Center
RECRUITING
Ashland
Marshfield Medical Center-EC Cancer Center
RECRUITING
Eau Claire
Essentia Health-Hayward Clinic
RECRUITING
Hayward
Tamarack Health Hayward Medical Center
RECRUITING
Hayward
Marshfield Medical Center-Marshfield
RECRUITING
Marshfield
Marshfield Medical Center - Minocqua
RECRUITING
Minocqua
Cancer Center of Western Wisconsin
RECRUITING
New Richmond
Marshfield Medical Center-Rice Lake
RECRUITING
Rice Lake
Essentia Health-Spooner Clinic
RECRUITING
Spooner
Marshfield Medical Center-River Region at Stevens Point
RECRUITING
Stevens Point
Essentia Health Saint Mary's Hospital - Superior
RECRUITING
Superior
Marshfield Medical Center - Weston
RECRUITING
Weston
Wyoming
Billings Clinic-Cody
RECRUITING
Cody
Welch Cancer Center
SUSPENDED
Sheridan
Contact Information
Primary
Jamie Crawley, MA
jcrawley@bsd.uchicago.edu
773-702-9934
Time Frame
Start Date: 2024-08-13
Estimated Completion Date: 2029-12-09
Participants
Target number of participants: 100
Treatments
Experimental: Arm I (nab-paclitaxel, gemcitabine, cisplatin)
Patients receive nab-paclitaxel IV over 30-40 minutes, gemcitabine IV over 30-40 minutes, and cisplatin IV over 30-60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study.
Active_comparator: Arm II (nab-paclitaxel, gemcitabine)
Patients receive nab-paclitaxel IV over 30-40 minutes and gemcitabine IV over 30-40 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study.
Sponsors
Leads: Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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