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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 belowSelect...
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:Select...
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.
Select...
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.
Select...
I have experienced severe side effects from initial chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients will be followed for 12 months after registration or until death, whichever occurs first.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be followed for 12 months after registration or until death, whichever occurs first.
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 moreTrial 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
708 Previous Clinical Trials
379,116 Total Patients Enrolled
Jason Molitoris, MDPrincipal InvestigatorUniversity of Maryland/Maryland Proton Treatment Center
1 Previous Clinical Trials
5 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You did not follow the doctor's instructions for the initial chemotherapy treatment.I have moderate to severe nerve pain or damage. I also have Gilbert's disease or a specific genetic condition.My diagnosis is pancreatic adenocarcinoma.I am not currently using, nor have I used in the last 14 days, any strong CYP3A4 inhibitors or inducers.I have not had chemotherapy, except for certain types.I haven't had radiation in the abdomen that would affect this study.I have not had surgery to remove pancreatic cancer.My scans show my tumor can't be surgically removed due to its location.I am HIV-positive and on antiretroviral therapy.My pancreatic cancer cannot be removed with surgery.Your kidneys are working well enough to filter out waste from your blood.Your total bilirubin level should be less than 2 mg/dL.Your platelet count is at least 100,000 per cubic millimeter.I am fully active or can carry out light work.You have enough infection-fighting white blood cells in your body.I have experienced severe side effects from initial chemotherapy.Your creatinine levels are within a certain range.My pancreatic cancer has not spread to distant areas.You have had to lower the dose of your chemotherapy more than two times.
Research Study Groups:
This trial has the following groups:- Group 1: Pancreatic Proton Therapy With Concurrent Gem + Nab-paclitaxel
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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.
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