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Combination Chemotherapy for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Olatunji B. Alese, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have a primary or metastatic non-bone site that is amenable to safe biopsy. Bone only lesions are not suitable for biopsy
Serum creatinine =< 1.5× ULN or creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x ULN. Creatinine clearance should be calculated per institutional standard (within 28 days of cycle 1 day 1)
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years from study start
Awards & highlights

Study Summary

This trial is testing a combination of drugs to see if they're more effective than standard chemotherapy for treating pancreatic cancer.

Who is the study for?
This trial is for adults with advanced or metastatic pancreatic cancer who haven't had chemotherapy for metastatic disease. They must have measurable disease, normal calcium levels, and be at least 21 days post-radiation therapy without toxicity. Participants need proper organ function, no severe pre-existing conditions that HCQ could worsen, and agree to use contraception. Pregnant women and those unable to swallow pills are excluded.Check my eligibility
What is being tested?
The trial tests a combination of paricalcitol (vitamin D) and hydroxychloroquine with standard chemotherapy drugs gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer. The study aims to see if this combo is more effective than the standard treatment alone.See study design
What are the potential side effects?
Potential side effects include typical chemotherapy-related issues like nausea, fatigue, hair loss; vitamin D related hypercalcemia; hydroxychloroquine's eye damage or heart rhythm problems; plus possible drug interactions affecting liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I have a cancer site other than bone that can be safely biopsied.
My kidney function, measured by creatinine or its clearance, is within the required range.
My cancer is a stage IV pancreatic adenocarcinoma.
I can take care of myself but may not be able to do heavy physical work.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years from study start
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years from study start for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline tumor size as measured by cross sectional imaging at 8 weeks.(every 8 weeks)
Secondary outcome measures
Incidence of adverse events
Overall survival
Progression-free survival
Other outcome measures
Changes in selected biomarkers in tumor microenvironment and circulation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (paricalcitol, hydroxychloroquine, chemotherapy)Experimental Treatment4 Interventions
Beginning day -14, patients receive paricalcitol IV three times weekly and hydroxychloroquine PO BID. Patients also receive gemcitabine IV over 30 minutes and nab-paclitaxel IV over 30 minutes on days 1, 8, 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3
Completed Phase 4
Completed Phase 3
Completed Phase 4

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,655 Total Patients Enrolled
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,561 Total Patients Enrolled
Olatunji B. Alese, MDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
81 Total Patients Enrolled

Media Library

Gemcitabine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04524702 — Phase 2
Pancreatic Cancer Research Study Groups: Treatment (paricalcitol, hydroxychloroquine, chemotherapy)
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT04524702 — Phase 2
Gemcitabine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04524702 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the approximate sample size of participants in this experiment?

"Affirmative. The clinicaltrial.gov database reveals that this medical study is currently recruiting candidates, with the initial posting on September 14th 2020 and most recent update occurring February 28th 2022. 21 participants are needed at 3 trial sites."

Answered by AI

What medical maladies is Nab-paclitaxel typically employed to treat?

"Nab-paclitaxel has a range of clinical applications, such as treating hypoalbuminemia and combating malarial infection and metastatic neoplasm growth. Additionally, it is sometimes employed to treat acute pyelonephritis (APN)."

Answered by AI

Has the FDA sanctioned Nab-paclitaxel for use in medical treatments?

"Nab-paclitaxel's safety has been evaluated and deemed to be a 2 on our team at Power's scale. This evaluation is based off the fact that this medication is in Phase 2 clinical trials, indicating some data supporting its security but none validating its efficacy."

Answered by AI

Are there any previous investigations that have employed Nab-paclitaxel?

"Currently, there are 1,200 active Nab-paclitaxel trials that span the globe. Of these studies, 334 have advanced to Phase 3. Shanghai is hosting a sizeable fraction of those trails with 60492 locations in total running experiments for this drug."

Answered by AI

Are there vacancies available for prospective participants in this trial?

"Affirmative. According to the content hosted on clinicaltrials.gov, this medical research project is seeking 21 individuals at 3 different sites. The study was published online on September 14th 2020 and has been updated as recently as February 28th 2022."

Answered by AI
~1 spots leftby Aug 2024