What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine and nab-paclitaxel, are associated with several side effects. Gemcitabine can cause fatigue, nausea, vomiting, and neutropenia (a decrease in white blood cells), which increases infection risk. Nab-paclitaxel, a formulation of paclitaxel, can lead to peripheral neuropathy (nerve damage causing pain or numbness), myelosuppression (bone marrow suppression), and gastrointestinal symptoms like diarrhea. Both drugs can also cause hair loss and an increased risk of infection due to their immunosuppressive effects.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, particularly focusing on combinations involving gemcitabine. One notable approval is for the combination of gemcitabine and nab-paclitaxel, which has shown significant efficacy in improving overall survival and progression-free survival in patients with metastatic pancreatic cancer. This combination was approved based on the results of the MPACT trial, which demonstrated superior outcomes compared to gemcitabine alone. Other treatments include FOLFIRINOX, a regimen combining fluorouracil, leucovorin, irinotecan, and oxaliplatin, which is also used for advanced pancreatic cancer. These treatments are part of the evolving landscape of pancreatic cancer therapy, aiming to improve patient outcomes.

What other types of research exist?

Promising novel alternatives to Paricalcitol for pancreatic cancer patients include: 1) Immunotherapy agents such as Nivolumab and Pembrolizumab, which have shown efficacy in certain subsets of pancreatic cancer patients. 2) Targeted therapies like Olaparib for patients with BRCA mutations. 3) Combination therapies involving chemotherapy agents like FOLFIRINOX or gemcitabine with nab-paclitaxel. 4) Experimental treatments such as CAR-T cell therapy and oncolytic virus therapy, which are currently under investigation in clinical trials.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Leg Cramps

Viral Infection

Hypercalcemia

Allergic Infection

Polydipsia

Dehydration

Urinary Tract Infection

Chest Pain

Sinusitis

Headache

General Infection

Asthenia

Fever

Infection Fungal

Conjuctivitis

Syncope

Depression

Increased Cough

Polyuria

Abdominal Pain

Photophobia

Decreased libido

Hypotension

Nausea

Esophageal ulcer

Somnolence

Back Pain

Vomiting

Pruritus

100%

80%

60%

40%

20%

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

0 / 14Eligibility criteria met

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.