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NCT04233866

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

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-26

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVE:

I. Overall survival.

SECONDARY OBJECTIVES:

I. Progression-free survival. II. Objective tumor response.

III. Comprehensive Geriatric Assessment (CGA)/quality of life (QOL) related objectives:

IIIa. Hypothesize that lower scores in functional status assessment tool - instrumental activities of daily living (IADL) will correlate with higher rates of grade 3 or higher chemotherapy toxicity.

IV. CGA/QOL related exploratory objectives:

IVa. Evaluation of other pre-treatment CGA domains including co-morbidities, depression, nutrition and cognition as predictors of chemotherapy tolerance.

IVb. Evaluation of the association between change in functional status during treatment course (comparison between activities of daily living \[ADL\] and IADL score pre-treatment and at time of disease evaluation) as predictors of chemotherapy tolerance.

IVc. Evaluation of the correlation between CGA domains and overall survival by treatment arm.

IVd. Evaluation of the difference in QOL scores (Functional Assessment of Cancer Therapy - Hepatitis \[FACT-Hep\] version 4) between baseline measures and assessment during treatment course between by treatment arms.

V. Focused evaluation of toxicities that are of interest for older patients including: peripheral neuropathy, fatigue, falls, emergency room visits, hospitalization, treatment modification and discontinuation.

VI. Imaging correlative study objectives:

VIa. Evaluate the association between baseline and change during treatment of skeletal muscle index (SMI) and intermuscular adipose tissue (IMAT) and rates of grade 3 or higher chemotherapy toxicity experienced on treatment.

VIb. Evaluate the association between baseline and change during treatment of skeletal muscle index (SMI) and intermuscular adipose tissue (IMAT) and overall survival among older patients with metastatic pancreatic cancer.

VIc. Evaluate the association between baseline and change during treatment of skeletal muscle index (SMI) and intermuscular adipose tissue (IMAT) and geriatric assessment scores evaluating functional status.

VII. Laboratory correlative study objectives:

VIIa. Evaluation of the correlation between base line levels of biomarkers of aging (CRP and IL-6) and rates of grade 3 or higher chemotherapy toxicity during therapy.

VIIb. Evaluation of the correlation between changes in levels of CRP and IL-6 during therapy and rates of grade 3 chemotherapy toxicity.

VIIc. Evaluation of the correlation between baseline levels of biomarkers of aging (CRP and IL-6) and overall survival among older patients with metastatic pancreatic cancer.

VIId. Evaluation of the correlation between levels of baseline biomarkers of aging (CRP and IL-6) and geriatric assessments scores evaluation functional status.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive gemcitabine intravenously (IV) over 30 minutes and nab-paclitaxel IV over 30 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive fluorouracil IV over 46 hours starting on day 1. Patients also receive leucovorin IV over 90-120 minutes and liposomal irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Conditions

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Metastatic Pancreatic Adenocarcinoma Stage IV Pancreatic Cancer AJCC v8

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

5 Fluorouracil 5 Fluorouracilum 5 FU 5-Fluoro-2,4(1H, 3H)-pyrimidinedione 5-Fluorouracil 5-Fluracil 5-FU 5FU AccuSite Carac Fluoro Uracil Fluouracil Flurablastin Fluracedyl Fluracil Fluril Fluroblastin Ribofluor Ro 2-9757 Ro-2-9757 dFdC dFdCyd Difluorodeoxycytidine dFdCyd Difluorodeoxycytidine Hydrochloride FF 10832 FF-10832 FF10832 Gemcitabine HCI Gemzar LY-188011 LY188011 Folinic acid Adinepar Calcifolin Calcium (6S)-Folinate Calcium Folinate Calcium Leucovorin Calfolex Calinat Cehafolin Citofolin Citrec Citrovorum Factor Cromatonbic Folinico Dalisol Disintox Divical Ecofol Emovis Factor, Citrovorum Flynoken A Folaren Folaxin FOLI-cell Foliben Folidan Folidar Folinac Folinate Calcium folinic acid Folinic Acid Calcium Salt Pentahydrate Folinoral Folinvit Foliplus Folix Imo Lederfolat Lederfolin Leucosar leucovorin Rescufolin Rescuvolin Tonofolin Wellcovorin Irinotecan Liposome MM-398 nal-IRI Nanoliposomal Irinotecan Nanoparticle Liposome Formulation of Irinotecan Onivyde PEP02 ABI 007 ABI-007 Abraxane Albumin-bound Paclitaxel Albumin-Stabilized Nanoparticle Paclitaxel Nanoparticle Albumin-bound Paclitaxel Nanoparticle Paclitaxel Paclitaxel Albumin paclitaxel albumin-stabilized nanoparticle formulation protein-bound paclitaxel Quality of Life Assessment

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Efrat Dotan

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Explore related publications, articles, or registry entries linked to this study.

Dotan E, Catalano P, Lenchik L, Boutin R, Yao X, Marques HS, Ioffe D, Zhen DB, Li D, Wagner LI, Simon MA, Wong TZ, O'Dwyer PJ. The GIANT trial (ECOG-ACRIN EA2186) methods paper: A randomized phase II study of gemcitabine and nab-paclitaxel compared with 5-fluorouracil, leucovorin, and liposomal irinotecan in older patients with treatment-naive metastatic pancreatic cancer - defining a new treatment option for older vulnerable patients. J Geriatr Oncol. 2023 Apr;14(3):101474. doi: 10.1016/j.jgo.2023.101474. Epub 2023 Mar 22.

Reference Type DERIVED

PMID: 36963200 (View on PubMed)

Other Identifiers

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NCI-2019-08286

Identifier Type: REGISTRY

Identifier Source: secondary_id

EA2186

Identifier Type: OTHER

Identifier Source: secondary_id

EA2186

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180820

Identifier Type: NIH

Identifier Source: secondary_id

View Link

EA2186

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Arm A (gemcitabine, nab-paclitaxel)

Gemcitabine

Gemcitabine Hydrochloride

Nab-paclitaxel

Quality-of-Life Assessment

Questionnaire Administration

Arm B (fluorouracil, leucovorin, liposomal irinotecan)

Fluorouracil

Leucovorin

Leucovorin Calcium

Liposomal Irinotecan

Quality-of-Life Assessment

Questionnaire Administration

Interventions

Fluorouracil

Gemcitabine

Gemcitabine Hydrochloride

Leucovorin

Leucovorin Calcium

Liposomal Irinotecan

Nab-paclitaxel

Quality-of-Life Assessment

Questionnaire Administration

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Sponsors

National Cancer Institute (NCI)

ECOG-ACRIN Cancer Research Group

Responsible Party

Principal Investigators

Efrat Dotan

Locations

University of Alabama at Birmingham Cancer Center

Thomas Hospital

Mobile Infirmary Medical Center

Anchorage Associates in Radiation Medicine

Anchorage Radiation Therapy Center

Alaska Breast Care and Surgery LLC

Alaska Oncology and Hematology LLC

Alaska Women's Cancer Care

Anchorage Oncology Centre

Katmai Oncology Group

Providence Alaska Medical Center

Kingman Regional Medical Center

Cancer Center at Saint Joseph's

Mercy Hospital Fort Smith

CHI Saint Vincent Cancer Center Hot Springs

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Mission Hope Medical Oncology - Arroyo Grande

PCR Oncology

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Mercy Cancer Center �� Carmichael

Mercy San Juan Medical Center

Community Cancer Institute

University Oncology Associates

City of Hope Comprehensive Cancer Center

Mercy Cancer Center - Elk Grove

City of Hope at Irvine Lennar

UC Irvine Health/Chao Family Comprehensive Cancer Center

Stanford Cancer Institute Palo Alto

Mercy Cancer Center - Rocklin

Mercy Cancer Center - Sacramento

Salinas Valley Memorial

Pacific Central Coast Health Center-San Luis Obispo

Mission Hope Medical Oncology - Santa Maria

City of Hope South Pasadena

City of Hope Upland

Woodland Memorial Hospital

Penrose-Saint Francis Healthcare

Rocky Mountain Cancer Centers-Penrose

UCHealth Memorial Hospital Central