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Chemotherapy
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)
Timeline
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 belowSelect...
I have a cancer site other than bone that can be safely biopsied.
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My kidney function, measured by creatinine or its clearance, is within the required range.
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My cancer is a stage IV pancreatic adenocarcinoma.
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I can take care of myself but may not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years from study start
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years from study start
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nab-paclitaxel
2014
Completed Phase 3
~2030
Paricalcitol
2013
Completed Phase 4
~1730
Gemcitabine
2017
Completed Phase 3
~2070
Hydroxychloroquine
2017
Completed Phase 4
~5360
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your calcium level is not too high according to the hospital's standard measurement.I haven't taken HCQ or paricalcitol in the last 6 months.You have certain medical conditions like G6PD deficiency, severe psoriasis, porphyria, macular degeneration, or severe diabetic retinopathy that can make the study drug hydroxychloroquine more harmful for you.I can swallow and absorb pills.My platelet count is at least 100,000 without recent transfusions.I will stop taking vitamin D or calcium supplements after joining the study.Your total bilirubin level must be within a certain range, as determined by the hospital's standard measurement.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am willing and able to follow the study's schedule and procedures.I had radiotherapy at least 3 weeks ago and have recovered from its side effects.I agree to use effective birth control during and 1 month after the study.I have a cancer site other than bone that can be safely biopsied.My hemoglobin level is at least 9.0 g/dl without recent transfusions.I have signed a consent form understanding my cancer, the study, and its risks and benefits.I have not received chemotherapy or experimental treatments for metastatic pancreatic cancer.I am not pregnant or breastfeeding.I am not pregnant and have taken a test to confirm this before starting therapy.My white blood cell count is healthy without needing help for over a week.I am not currently using any other cancer treatments.I do not have uncontrolled brain metastases.I am not on medications that affect heart rhythm or certain liver enzymes, or have PI approval.You need to have a measurable disease according to specific medical guidelines.You have a specific enzyme deficiency or certain eye conditions that could make the treatment harmful for you.I had treatment for pancreatic cancer but no treatment for cancer that has spread, and my last chemotherapy was over a year ago.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.My kidney function, measured by creatinine or its clearance, is within the required range.Your blood clotting time must be within a certain range.You have high levels of calcium in your blood before starting the study.I have severe nerve damage that affects my senses or movement.My cancer is a stage IV pancreatic adenocarcinoma.I can take care of myself but may not be able to do heavy physical work.Your blood clotting test (INR) should be less than or equal to 1.5 within 28 days before starting the treatment.Your liver function tests should not show more than 5 times the upper limit of normal within 28 days before starting the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (paricalcitol, hydroxychloroquine, chemotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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
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