NCT02030860

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

January 7, 2014

Last Update Submit

July 22, 2025

Conditions

Adenocarcinoma of the Pancreas

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    number of adverse events in 2years

    2 years

Study Arms (2)

Pre-operative Paricalcitol

EXPERIMENTAL

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).

Drug: ParicalcitolDrug: AbraxaneDrug: Gemcitabine

No Pre-operative Paricalcitol

ACTIVE COMPARATOR

Subject will receive gemcitabine/abraxane without paricalcitol preoperatively.

Drug: AbraxaneDrug: Gemcitabine

Interventions

ParicalcitolDRUG

Dose: 25 micrograms Route: IV Frequency (within a 28 day cycle):Three times weekly for one cycle beginning day 1 of therapy until the day before surgery (+/- 3 days) (for subjects randomized to receive paricalcitol), then three times weekly for 3 cycles post-operatively (for all subjects).

Pre-operative Paricalcitol
AbraxaneDRUG

Dose: 125mg/m2 Route: IV infusion over 30 minutes Frequency (within a 28 day cycle): Day 1, 8, 15

No Pre-operative ParicalcitolPre-operative Paricalcitol
GemcitabineDRUG

Dose: 1000mg/m2 Route: IV infusion over 30-100 minutes Frequency (within a 28 day cycle): Day 1, 8, 15

No Pre-operative ParicalcitolPre-operative Paricalcitol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

paricalcitolAlbumin-Bound PaclitaxelGemcitabine

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Peter O'Dwyer, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 9, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 25, 2025

Record last verified: 2025-07

Locations

US(1)