Pre-operative Treatment for Patients With Untreated Pancreatic Cancer (NCT03138720) | Clinical Trial Compass
CompletedPhase 2
Pre-operative Treatment for Patients With Untreated Pancreatic Cancer
United States40 participantsStarted 2017-05-23
Plain-language summary
The purpose of this study is to determine if the combination of paclitaxel protein bound, gemcitabine, cisplatin, paricalcitol are effective in individuals with resectable and unresectable pancreatic cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient has histologically or cytologically confirmed resectable, borderline resectable, or locally advanced (unresectable) PDAC (based upon Tempero et al 2016)
✓. Age ≥ 18 years.
✓. If a female patient is of child-bearing potential, she must have a negative serum pregnancy test (≥β-hCG) documented within 72 hours of the first administration of study drug
✓. If sexually active, the patient and partner must agree to use contraception considered adequate and appropriate by the Investigator
✓. Patient must have received no prior chemotherapy or radiation therapy for PDAC
✓. Patients must have normal organ and marrow function as defined below:
✓. Patient has acceptable coagulation status as indicated by an INR ≤ 1.5 x ULN. Patients on anticoagulation can be included at the discretion of the investigator.
✓. Karnofsky Performance Status (KPS) of ≥70%.
Exclusion criteria
✕. Patient will be excluded from this study if any of the following criteria apply: Evidence of metastatic disease. No metastatic disease defined as any one or more of the following:
. Has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
✕. History of allergy or hypersensitivity to the study drugs.
✕. Serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
✕. Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
✕. Patient is unwilling or unable to comply with study procedures.