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Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients with Pancreatic Cancer that has Spread


Title EA2186 - 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)
Therapeutic Area Pancreatic Cancer
Principal Investigator Jacob Elkon, MD
Min Age 70 Years
Gender Both
Contact NCCCR Staff
617-636-3264
NCCCR@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04233866?term=NCT04233866&draw=2&rank=1

Overview

This study is being done to answer the following question:

Which of two treatment combinations, Gemcitabine and Nab-paclitaxel or 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan, is more effective at lengthening the period of time that less fit patients over the age of 70 years with metastatic pancreatic cancer (mPCA) live?

Study Details

Inclusion Criteria

1. Patient must have newly diagnosed untreated biopsy proven metastatic adenocarcinoma of the pancreas. However, previous surgery, adjuvant chemotherapy and/or radiation therapy will be allowed under certain circumstances.
2. Patient must have an ECOG Performance status 0-2
3. Patient must be an English speaker with the ability to understand and complete the informed consent and questionnaires
 

Exclusion Criteria

1. Patients with the following histology are excluded: Acinar cell; Adenosquamous carcinoma
2. Patient without adequate organ and marrow function

Study Requirements

Subjects will be randomized to either get Gemcitabine and Nab-paclitaxel every other week or 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan every other week. These two treatments have helped younger patients with metastatic pancreatic cancer to survive longer as first and second treatment options. Due to the higher risk for chemotherapy-related side effects among older patients, subjects will receive a slightly reduced dose of these chemotherapy combinations.

Subjects will complete a full geriatric assessment and quality of life questionnaire, and be required to complete a shorter version of this assessment every 8 weeks.

Subjects will remain on therapy until their cancer gets worse or they develop serious side effects to the treatment.

The study doctor will continue to follow the subject’s condition for up to 2 years after starting the study, and watch them for side effects and monitor their cancer.