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Alkylating Agent

Paricalcitol + Chemotherapy for Pancreatic Cancer

Phase 1 & 2
Waitlist Available
Led By Kimberly Perez, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age greater than or equal to 18 years
Histologically-confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma that is metastatic to distant sites
Must not have
Pre-existing hypercalcemia
Pre-existing, clinically significant peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years

Summary

This trial is testing if adding a form of vitamin D to usual cancer treatment can improve treatment for patients with advanced pancreatic cancer. Pancreatic cancer is very aggressive, and current treatments are not very effective. This form of vitamin D might help by blocking signals that make cancer cells grow and spread.

Who is the study for?
This trial is for adults with previously untreated, metastatic pancreatic cancer. They should have measurable disease, be in good physical condition (ECOG ≤1), and have normal organ/marrow function. Participants must not have had chemotherapy for advanced pancreatic cancer or certain other treatments recently and agree to use contraception.
What is being tested?
The study tests adding paricalcitol (IV or Oral) to standard chemo drugs gemcitabine and nab-paclitaxel in two stages: first checking safety (run-in phase) then assessing effectiveness (randomized phase). The goal is to see if paricalcitol improves treatment outcomes.
What are the potential side effects?
Possible side effects include those from standard chemo like nausea, fatigue, hair loss, low blood cell counts leading to increased infection risk; plus specific risks from paricalcitol such as high calcium levels which can cause kidney stones or digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is a type of pancreatic cancer that has spread to distant parts of my body.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I am not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have high calcium levels in my blood.
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I have severe nerve pain or numbness.
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I do not have any unmanaged ongoing illnesses.
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I can swallow and absorb pills.
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I am allergic to medications similar to paricalcitol, gemcitabine, or nab-paclitaxel.
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I am not taking any drugs that affect the CYP450 3A enzyme.
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I am not using any other cancer treatments.
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I have brain metastases.
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I have had chemotherapy or experimental treatments for advanced pancreatic cancer.
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I regularly take water pills for my blood pressure or swelling.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall survival
Secondary study objectives
Assess adverse events (per CTCAE v4.0 criteria)
Progression free survival
Response rate

Side effects data

From 2010 Phase 4 trial • 109 Patients • NCT01265615
23%
Hypophospatemia
17%
Fatigue
13%
Increased hypertension
13%
Edema
13%
Diarrhea
13%
Pain
10%
Taste perversions
10%
Arthritis
10%
Dizziness
10%
Gastroenteritis
10%
Vertigo
10%
Rhinitis
10%
Bronchitis
10%
Rash
7%
Leg Cramps
7%
Viral Infection
7%
Hypercalcemia
7%
Allergic Infection
7%
Polydipsia
7%
Dehydration
7%
Urinary Tract Infection
3%
Chest Pain
3%
Sinusitis
3%
Headache
3%
General Infection
3%
Asthenia
3%
Fever
3%
Infection Fungal
3%
Conjuctivitis
3%
Syncope
3%
Depression
3%
Increased Cough
3%
Polyuria
3%
Abdominal Pain
3%
Photophobia
3%
Decreased libido
3%
Hypotension
3%
Nausea
3%
Esophageal ulcer
3%
Somnolence
3%
Back Pain
3%
Vomiting
3%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paricalcitol Treatment
Calcitriol Treatment
Cholecalciferol
Supplemental

Trial Design

3Treatment groups
Experimental Treatment
Group I: Gemcitabine + Nab-paclitaxel + PlaceboExperimental Treatment3 Interventions
* Gemcitabine and Nab-paclitaxel is administered intravenously 3 times/cycle. * Placebo is administered orally on a daily basis
Group II: Gemcitabine + Nab-paclitaxel + Paricalcitol oralExperimental Treatment3 Interventions
* Gemcitabine + Nab-paclitaxel is administered intravenously 3 times/cycle. * Paricalcitol is administered orally on a daily basis
Group III: Gemcitabine + Nab-paclitaxel + Paricalcitol IVExperimental Treatment3 Interventions
* Gemcitabine + Nab-paclitaxel is administered intravenously 3 times/cycle. * Paricalcitol is administered intravenously once weekly.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~1920
Paricalcitol
2013
Completed Phase 4
~1730
Nab-paclitaxel
2014
Completed Phase 3
~1950

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pancreatic cancer, such as gemcitabine and nab-paclitaxel, work by disrupting DNA replication, which inhibits cancer cell growth and induces cell death. Paricalcitol, a synthetic vitamin D analog, may enhance these effects by modulating the immune response, inhibiting cancer cell proliferation, and promoting cancer cell differentiation and apoptosis. These mechanisms are important for pancreatic cancer patients as they underscore the need for a comprehensive treatment strategy to effectively combat this aggressive disease and improve patient outcomes.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,103 Previous Clinical Trials
359,362 Total Patients Enrolled
Stand Up To CancerOTHER
51 Previous Clinical Trials
40,067 Total Patients Enrolled
Lustgarten FoundationOTHER
23 Previous Clinical Trials
5,337 Total Patients Enrolled

Media Library

Gemcitabine (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03520790 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: Gemcitabine + Nab-paclitaxel + Placebo, Gemcitabine + Nab-paclitaxel + Paricalcitol IV, Gemcitabine + Nab-paclitaxel + Paricalcitol oral
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT03520790 — Phase 1 & 2
Gemcitabine (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03520790 — Phase 1 & 2
~5 spots leftby Oct 2025