Status and phase
Conditions
Treatments
About
The main purpose of this study is to look at the potential effects of paricalcitol (a drug similar to vitamin D) and nivolumab on pancreatic tumors in patients who are treated with gemcitabine and abraxane. The study will also look at the safety of including paricalcitol and nivolumab as part of the gemcitabine and abraxane chemotherapeutic regimen.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Previously untreated, apparently resectable adenocarcinoma of the pancreas at registration.
Age greater than or equal to 18 years
ECOG performance status of 0-2.
Standard laboratory criteria for hematologic, biochemical, and urinary indices within a range that, in the opinion of the physician, clinically supports enrollment of the subject on the trial.
a. Note: subjects must have: Creatinine < 2xULN, Neutrophils >1.5x109/L, total bilirubin < 3xULN, AST <5xULN, ALT <5xULN, and Platelets >100,000/mm3
Ability to provide written informed consent
Exclusion criteria
Subjects with hypercalcemia (blood levels greater than 11.5 mg/dL). In subjects creatinine clearance <60mL/min, blood calcium levels must be 9.5 mg/dL or lower.
Subjects who are currently pregnant, planning to become pregnant, or breast-feeding
Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
Prior organ allograft or allogeneic bone marrow transplantation
Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
Active autoimmune disease, except for vitiligo, type 1 diabetes mellitus, asthma, atopic dermatitis, or endocrinopathies manageable by hormone replacement; other autoimmune conditions may be allowable at the discretion of the principal investigator
Condition requiring systemic treatment with either corticosteroids
Primary purpose
Allocation
Interventional model
Masking
3 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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