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Anti-metabolites

Chemotherapy + Proton Therapy for Pancreatic Cancer

Phase 1 & 2
Recruiting
Led By Jason Molitoris, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cytologic or histologic proof of adenocarcinoma of the pancreas
Unequivocal radiographic findings contraindicating resection including, but not limited to, solid tumor contact with specific anatomical structures
Must not have
Baseline Grade ≥ 2 neuropathy. Known Gilbert's disease or known homozygosity for UGAT1A1*28 polymorphism
Chronic concomitant treatment with strong inhibitors of CYP3A4. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to the start of study treatment. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be followed for 12 months after registration or until death, whichever occurs first.
Awards & highlights

Summary

This trial is testing a new way to give proton therapy and chemotherapy for pancreatic cancer.

Who is the study for?
This trial is for adults with nonmetastatic pancreatic cancer that can't be surgically removed. They should have good physical function (able to carry out daily activities) and adequate blood counts, kidney, and liver functions. Pregnant or breastfeeding individuals, those who've had certain prior treatments or surgeries for pancreatic cancer, or have specific genetic conditions are excluded.
What is being tested?
The study aims to find the highest dose of nab-paclitaxel and gemcitabine chemotherapy drugs that's safe when given with a type of targeted radiation called hypofractionated ablative proton therapy over three weeks to treat advanced pancreatic cancer.
What are the potential side effects?
Potential side effects include reactions from chemotherapy like nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems; skin changes from radiation; and possible damage to nearby organs due to the precision of proton therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis is pancreatic adenocarcinoma.
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My scans show my tumor can't be surgically removed due to its location.
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I am fully active or can carry out light work.
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My pancreatic cancer has not spread to distant areas.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have moderate to severe nerve pain or damage. I also have Gilbert's disease or a specific genetic condition.
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I am not currently using, nor have I used in the last 14 days, any strong CYP3A4 inhibitors or inducers.
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I have not had chemotherapy, except for certain types.
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I haven't had radiation in the abdomen that would affect this study.
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I have not had surgery to remove pancreatic cancer.
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I am HIV-positive and on antiretroviral therapy.
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My pancreatic cancer cannot be removed with surgery.
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I have experienced severe side effects from initial chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be followed for 12 months after registration or until death, whichever occurs first.
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be followed for 12 months after registration or until death, whichever occurs first. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose of Gemcitabine and nab-Paclitaxel in LAPC patients receiving proton therapy
Secondary study objectives
Median Overall Survival of Patients
Number of adverse events/toxicites reported during and following treatment of concurrent nab-paclitaxel + gemcitabine combined with hypofractionated ablative proton therapy
Primary Tumor Response in LAPC patients receiving proton therapy with concurrent Gemcitabine and nab-Paclitaxel
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pancreatic Proton Therapy With Concurrent Gem + Nab-paclitaxelExperimental Treatment2 Interventions
Part I: Gemcitabine + nab-paclitaxel: • Administered per institutional standard every 7 days for 3 weeks Part II: Hypofractionated ablative pancreatic proton radiation therapy 67.5 Gy fractions once per day Monday - Friday for 3 weeks, for a total of 15 fractions. Part III: Surgery, if resectable, then adjuvant chemo per discretion of MD or no further therapy OR Chemo per discretion of MD if not resectable
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
705 Previous Clinical Trials
378,436 Total Patients Enrolled
Jason Molitoris, MDPrincipal InvestigatorUniversity of Maryland/Maryland Proton Treatment Center
1 Previous Clinical Trials
5 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03652428 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: Pancreatic Proton Therapy With Concurrent Gem + Nab-paclitaxel
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT03652428 — Phase 1 & 2
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03652428 — Phase 1 & 2
~4 spots leftby Dec 2025
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