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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of adding paricalcitol to gemcitabine and nab-paclitaxel in people with previously untreated, metastatic pancreatic cancer.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
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I am not pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Secondary outcome measures
Assess adverse events (per CTCAE v4.0 criteria)
Progression free survival
Response rate
Side effects data
From 2010 Phase 4 trial • 109 Patients • NCT0126561523%
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%
Viral Infection
7%
Leg Cramps
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
~2070
Paricalcitol
2013
Completed Phase 4
~1730
Nab-paclitaxel
2014
Completed Phase 3
~2030
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,941 Total Patients Enrolled
Stand Up To CancerOTHER
51 Previous Clinical Trials
40,258 Total Patients Enrolled
Lustgarten FoundationOTHER
23 Previous Clinical Trials
5,337 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have high calcium levels in my blood.I have had painful kidney or bladder stones in the last year.I have severe nerve pain or numbness.I do not have any unmanaged ongoing illnesses.I can swallow and absorb pills.I am 18 years old or older.I am allergic to medications similar to paricalcitol, gemcitabine, or nab-paclitaxel.My cancer is a type of pancreatic cancer that has spread to distant parts of my body.It has been over 4 weeks since my last major surgery or open biopsy.I have had cancer before, but it meets certain conditions.I am fully active and can carry on all my pre-disease activities without restriction.I am not taking any drugs that affect the CYP450 3A enzyme.You need to have a specific amount of disease that can be measured according to certain standards.I am not pregnant.My organ and bone marrow functions are normal.I am not using any other cancer treatments.I have brain metastases.I have had chemotherapy or experimental treatments for advanced pancreatic cancer.I regularly take water pills for my blood pressure or swelling.I finished my post-surgery cancer treatment over a year ago.
Research Study Groups:
This trial has the following groups:- Group 1: Gemcitabine + Nab-paclitaxel + Placebo
- Group 2: Gemcitabine + Nab-paclitaxel + Paricalcitol IV
- Group 3: Gemcitabine + Nab-paclitaxel + Paricalcitol oral
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients still being accepted for this clinical research program?
"This study, which was last updated on October 24th 2022 and was first posted December 5th 2018, is not currently looking for patients. However, 1893 other studies are presently recruiting patients."
Answered by AI
How many people are part of this experiment?
"Right now, this trial does not have any open positions. However, it is still an active study; the first posting was on December 5th, 2018 and the most recent edit was on October 24th, 2022. If you are interested in other studies, there are 726 trials for cancer of the pancreas and 1167 for Paricalcitol that are actively recruiting participants."
Answered by AI
What are the most common illnesses that Paricalcitol is used to manage?
"Paricalcitol is commonly used as a treatment for neoplasm metastasis. Additionally, it has shown efficacy in treating locally advanced non-small cell lung cancer, metastatic bladder cancer, and urinary bladder."
Answered by AI
What other medical studies involving Paricalcitol have been completed?
"Paricalcitol was first studied in 1997 and there have been over 2000 completed clinical trials involving this medication. Currently, 1167 studies are recruiting patients with a large number of these based out of Boston, Massachusetts."
Answered by AI
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