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

NCT ID: NCT03300921

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-28
• Study Completion Date: 2022-03-23

Brief 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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Arm A: 50mcg IV weekly

Group Type: EXPERIMENTAL

Paricalcitol

Intervention Type: DRUG

Product: Paricalcitol

Dose/Route/Regimen:

Arm A: 50mcg IV weekly Arm B: 12mcg PO daily

Arm B

Arm B: 12mcg PO daily

Group Type: EXPERIMENTAL

Paricalcitol

Intervention Type: DRUG

Product: Paricalcitol

Dose/Route/Regimen:

Arm A: 50mcg IV weekly Arm B: 12mcg PO daily

Interventions

Paricalcitol

Product: Paricalcitol

Dose/Route/Regimen:

Arm A: 50mcg IV weekly Arm B: 12mcg PO daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter O'Dwyer, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 26217

Identifier Type: -

Identifier Source: org_study_id