Clinical trial · Interventional
A Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
A Randomized Pilot/Pharmacodynamic/Genomic Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
NCT02030860CI-TRIAL-00092641completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Pancreas | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane | Drug | Paclitaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Paricalcitol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pre-operative Paricalcitol
- 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).
- interventionNames
- Drug: Paricalcitol
- Drug: Abraxane
- Drug: Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- No Pre-operative Paricalcitol
- description
- Subject will receive gemcitabine/abraxane without paricalcitol preoperatively.
- interventionNames
- Drug: Abraxane
- Drug: Gemcitabine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.