Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
University of Maryland, Baltimore
Study ID
NCT03652428
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    see arm description
  • Hypofractionated Ablative Proton Therapy — RADIATION
    see arm description

Study Details

The purpose of this study is to determine the maximum tolerated dose of the chemotherapy drugs nab-paclitaxel and gemcitabine when combined with hypofractionated ablative proton therapy for the treatment of locally advanced pancreatic cancer. You will receive proton therapy once a day (Monday - Friday) for 3 weeks. Participants will also receive chemotherapy on each Monday of those three weeks.

Key Dates

Start date
Apr 2, 2019
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Pancreatic Proton Therapy With Concurrent Gem + Nab-paclitaxel
    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

Primary Outcome Measure

Maximum Tolerated Dose of Gemcitabine and nab-Paclitaxel in LAPC patients receiving proton therapy [ Time Frame: Patients will be followed for 12 months after registration or until death, whichever occurs first. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007
Nicole Villa, MSN, RN
[email protected]
202-687-2939
Keith Unger, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland Medical Center/Maryland Proton Treatment CenterBaltimoreMaryland21201
Jasmine A Newman, BS
[email protected]
410-369-5355
Jason Molitoris, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By research site
MedStar Georgetown University Hospital· Washington D.C., DCUniversity of Maryland Medical Center/Maryland Proton Treatment Center· Baltimore, MD

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