A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer



Status:Recruiting
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/2/2017
Start Date:September 28, 2017
End Date:May 28, 2019
Contact:Peter O'Dwyer, MD
Email:PennCancerTrials@emergingmed.com
Phone:855-216-0098

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A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer

The main purpose of this study is to look at the potential effects of paricalcitol (a drug
similar to vitamin D) on pancreatic tumors in patients who are planned for surgical removal
of their tumor. The study will also look at the safety of paricalcitol prior to surgery.


Inclusion Criteria:

- Previously untreated, apparently resectable, adenocarcinoma of the pancreas at
registration.

- Age greater than or equal to 18 years

- Medically fit for surgery in the opinion of the treating surgeon

- Ability to provide written informed consent

Exclusion Criteria:

- Patients who are currently pregnant, planning to become pregnant, or breast-feeding.

Note: women of childbearing potential must agree to use a medically accepted form of birth
control including (condoms, diaphragms, cervical cap, an intra-uterine device (IUD),
surgical sterility [tubal ligation or a partner that has undergone a vasectomy], or oral
contraceptives). OR must agree to completely abstain from intercourse for two weeks before
beginning study treatment, during participation in this study, and for 2 weeks after the
final study treatment

- Patients with hypercalcemia (blood levels greater than 11.5 mg/dL). Note: In patients
with GFR 30-60 mL/min by Cockroft-Gault, blood calcium levels must be 9.5 mg/dL or
lower before starting paricalcitol.

- Serum creatinine > 2.5 x ULN OR GFR <30 mL/min by Cockroft-Gault formula . Patients
who, in the opinion of the physician, would not be clinically appropriate for receipt
of the therapy regimen associated with participation.
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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mi
from
Philadelphia, PA
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