Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovo… (NCT04233866) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread
United States176 participantsStarted 2020-08-26
Plain-language 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.
Who can participate
Age range70 Years
SexALL
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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 lowe…