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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03300921
• Other study ID #: UPCC 26217
• Status: Terminated
• Phase: Phase 1
• Start date: September 28, 2017
• Est. completion date: March 23, 2022

Study information

• Verified date: March 2022
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 23, 2022
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Paricalcitol
Product: Paricalcitol Dose/Route/Regimen: Arm A: 50mcg IV weekly Arm B: 12mcg PO daily

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		18 months