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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

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

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 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.

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

Awards & Highlights

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.

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

0 / 12Eligibility criteria met