A Randomized Pilot/Pharmacodynamic/Genomic Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer

Abramson Cancer Center at Penn Medicine

Status and phase

Completed

Phase 1

Conditions

Adenocarcinoma of the Pancreas

Treatments

Drug: Paricalcitol

Drug: Gemcitabine

Drug: Abraxane

Study type

Interventional

Funder types

Other

Identifiers

NCT02030860

UPCC 23213

Details and patient eligibility

About

This study is a randomized pilot/pharmacodynamic/genomic study of neoadjuvant paricalcitol to target the microenvironment in resectable pancreatic cancer to determine the effect of targeting the vitamin D metabolic program in the tumors of patients treated with one cycle of gemcitabine/abraxane with or without paricalcitol prior to surgery for resectable pancreatic cancer through an assessment of cellular and imaging markers.

Full description

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Previously untreated, apparently resectable, adenocarcinoma of the pancreas at registration.
Age greater than or equal to 18 years
Eastern Cooperative Oncology Group 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 patient on the trial. Note: subjects must have: Creatinine < 2x Upper Normal Limit , Transaminases < 3x Upper Normal Limit, Neutrophils >1.5x109/L, and Platelets >100,000/mm3
Ability to provide written informed consent

Exclusion Criteria

Patients with hypercalcemia (blood levels greater than 11.5 mg/dL; in patients with kidney disease, blood calcium levels must be 9.5 mg/dL or lower before starting paricalcitol).
Patients who are currently pregnant, planning to become pregnant, or breast-feeding.
Patients who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Pre-operative Paricalcitol

Experimental group

Description:

Subject will receive gemcitabine/abraxane with preoperatively paricalcitol. Patients randomized to receive paricalcitol pre-operatively will begin treatment with intravenous paricalcitol at 25 μg three times weekly for one cycle beginning day 1 of therapy until the day before surgery (+/- 3 days).

Treatment:

Drug: Gemcitabine

Drug: Paricalcitol

Drug: Abraxane

No Pre-operative Paricalcitol

Active Comparator group

Description:

Subject will receive gemcitabine/abraxane without paricalcitol preoperatively.

Treatment:

Drug: Gemcitabine

Drug: Abraxane