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ACTIVE NOT RECRUITING

NCT04233866

PHASE2

Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread

Sponsor: ECOG-ACRIN Cancer Research Group

View on ClinicalTrials.gov

Summary

This phase II trial compares two treatment combinations: gemcitabine hydrochloride and nab-paclitaxel, or fluorouracil, leucovorin calcium, and liposomal irinotecan in older patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine hydrochloride, nab-paclitaxel, fluorouracil, leucovorin calcium, and liposomal irinotecan, 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. This study may help doctors find out which treatment combination is better at prolonging life in older patients with metastatic pancreatic cancer.

Official title: A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients With Treatment Naïve Metastatic Pancreatic Cancer (GIANT)

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

176

Start Date

2020-08-26

Completion Date

2026-12-31

Last Updated

2026-07-10

Healthy Volunteers

Conditions

Metastatic Pancreatic Adenocarcinoma Stage IV Pancreatic Cancer AJCC v8

Interventions

DRUG

Fluorouracil

Given IV

DRUG

Gemcitabine

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

DRUG

Leucovorin

Given IV

DRUG

Leucovorin Calcium

Given IV

DRUG

Liposomal Irinotecan

Given IV

DRUG

Nab-paclitaxel

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Inclusion Criteria: * Newly diagnosed untreated metastatic adenocarcinoma of the pancreas. However, previous surgery, adjuvant chemotherapy and/or radiation therapy will be allowed, provided radiation therapy is completed at least 2 weeks prior to registration and adjuvant therapy was administered more than 6 months prior to registration. Patients with the following histology are excluded: acinar cell; adenosquamous carcinoma * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patient is an English speaker with the ability to understand and complete the informed consent and questionnaires * Leukocytes \>= 3,000/mcL (obtained within 4 weeks of registration) * Absolute neutrophil count \>= 1,500/mcL (obtained within 4 weeks of registration) * Platelets \>= 100,000/mcL (obtained within 4 weeks of registration) * Total bilirubin =\< institutional upper limit of normal (ULN) (obtained within 4 weeks of registration) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (obtained within 4 weeks of registration) * Creatinine =\< institutional ULN unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\^2 (obtained within 4 weeks of registration) * Glomerular filtration rate (GFR) \>= 40 mL/min/1.73 m\^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\^2 (obtained within 4 weeks of registration) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this protocol. HIV positive (+) patients who are on ritonavir or/and cobicistat-based regimen must be switched to alternative anti-retroviral therapy (ART) * 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 * Male patients must agree not to father children while on study * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this protocol, patients should be class 2B or better * Patients must have measurable disease and scans must be done within 4 weeks of registration * Patients classified to have mild-moderate abnormalities in any of the domains evaluated in the screening geriatric assessment and are classified as "vulnerable" are eligible. Patients classified without any abnormalities ("fit") or with severe cognitive/functional impairment or high co-morbidity score ("frail") on the screening geriatric assessment are ineligible * Patients must agree not to take any medications or substances that are strong inhibitors or inducers of CYP3A4. Those who are randomized to liposomal irinotecan treatment arm should avoid drugs that are UGT1A1 inhibitors

Locations (760)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Thomas Hospital

Fairhope, Alabama, United States

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Anchorage Radiation Therapy Center

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

Kingman Regional Medical Center

Kingman, Arizona, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

PCR Oncology

Arroyo Grande, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Mercy Cancer Center �� Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Community Cancer Institute

Clovis, California, United States

University Oncology Associates

Clovis, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

Salinas Valley Memorial

Salinas, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

City of Hope Upland

Upland, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Memorial Hospital North

Colorado Springs, Colorado, United States

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

Mercy Medical Center

Durango, Colorado, United States

Southwest Oncology PC

Durango, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

UCHealth Greeley Hospital

Greeley, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

Littleton Adventist Hospital

Littleton, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Parker Adventist Hospital

Parker, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Beebe South Coastal Health Campus

Frankford, Delaware, United States

Beebe Medical Center

Lewes, Delaware, United States

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

TidalHealth Nanticoke / Allen Cancer Center

Seaford, Delaware, United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

George Washington University Medical Center

Washington D.C., District of Columbia, United States

AdventHealth Altamonte

Altamonte Springs, Florida, United States

AdventHealth Celebration

Celebration, Florida, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Regional Cancer Center-Lee Memorial Health System

Fort Myers, Florida, United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

AdventHealth Kissimmee

Kissimmee, Florida, United States

The Watson Clinic

Lakeland, Florida, United States

AdventHealth Medical Group Urology at Orlando

Orlando, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

AdventHealth East Orlando

Orlando, Florida, United States

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, United States

AdventHealth Winter Park

Winter Park, Florida, United States

Augusta Oncology Associates PC-D'Antignac

Augusta, Georgia, United States

Augusta Oncology Associates PC-Wheeler

Augusta, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza