Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients with Pancreatic Cancer That Has Spread
Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients with Pancreatic Cancer That Has Spread
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.
Pancreatic
Phase II
Adults
Chemotherapy - cytotoxic
Fluorouracil (5-FU),
Gemcitabine,
Leucovorin,
Liposomal Irinotecan,
Nab-Paclitaxel
Cardin, Dana
National
Vanderbilt University
02-12-2021
Treatment
ECOGGIEA2186
NCT04233866
Eligibility
70 Years
BOTH
NO
Inclusion Criteria:
Patient must have newly diagnosed untreated biopsy proven metastatic adenocarcinoma of the pancreas. If a patient had a biopsy of the pancreatic mass and the clinical picture is consistent with metastatic pancreatic cancer, another biopsy of a metastatic site is not required for this trial. Patients with acinar cell or adenosquamous carcinoma histology are ineligible. Patients with neuroendocrine histology are ineligible
Patients who have had previous surgery, adjuvant/neoadjuvant chemotherapy and/or radiation therapy will be allowed to enroll, provided therapy was completed at least 6 months prior to randomization. Palliative radiation to a metastatic site prior to study enrollment is allowed
Patient must be >= 70 years of age
Patient must have an 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 randomization)
Absolute neutrophil count >= 1,500/mcL (obtained within 4 weeks of randomization)
Platelets >= 100,000/mcL (obtained within 4 weeks of randomization)
Total bilirubin =
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =
Creatinine == 40 mL/min/1.73 m^2 (obtained within 4 weeks of randomization)
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization 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
Patients must agree not to father children while on study and for 3 months after the last dose of protocol treatment.
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 2 or better
Patients must have measurable disease and scans must be done within 4 weeks of randomization
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 should avoid taking 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
Patient must have newly diagnosed untreated biopsy proven metastatic adenocarcinoma of the pancreas. If a patient had a biopsy of the pancreatic mass and the clinical picture is consistent with metastatic pancreatic cancer, another biopsy of a metastatic site is not required for this trial. Patients with acinar cell or adenosquamous carcinoma histology are ineligible. Patients with neuroendocrine histology are ineligible
Patients who have had previous surgery, adjuvant/neoadjuvant chemotherapy and/or radiation therapy will be allowed to enroll, provided therapy was completed at least 6 months prior to randomization. Palliative radiation to a metastatic site prior to study enrollment is allowed
Patient must be >= 70 years of age
Patient must have an 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 randomization)
Absolute neutrophil count >= 1,500/mcL (obtained within 4 weeks of randomization)
Platelets >= 100,000/mcL (obtained within 4 weeks of randomization)
Total bilirubin =
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =
Creatinine == 40 mL/min/1.73 m^2 (obtained within 4 weeks of randomization)
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization 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
Patients must agree not to father children while on study and for 3 months after the last dose of protocol treatment.
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 2 or better
Patients must have measurable disease and scans must be done within 4 weeks of randomization
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 should avoid taking 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
