Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC

Part of paid clinical trials in Loma Linda, California.

Sponsor
RenovoRx
Study ID
NCT03257033
Phase
PHASE3
Status
Recruiting
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Conditions

  • Locally Advanced Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Chemotherapy
  • nab-paclitaxel — DRUG
    Chemotherapy
  • RenovoCath — DEVICE
    Intra-arterial catheter

Study Details

The study is a multi-center, open-label, randomized active controlled study of subjects with locally advanced pancreatic adenocarcinoma which is unresectable.

Key Dates

Start date
Mar 12, 2018
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IA Therapy
    IA Treatments with 1,000 mg/m2 gemcitabine administered through RenovoCath every other week for a maximum of 8 treatments for approximately 16 weeks.
  • Active Comparator: IV Therapy
    IV gemcitabine and nab-paclitaxel will be administered for 16 weeks on days 1, 8, and 15 of a 28 day cycle. Nab-paclitaxel will be administered intravenously following pre-medication at a dose of 125 mg/m2 over 30 minutes followed by an infusion of gemcitabine at a dose of 1000 mg/m2 over 30 minutes.

Primary Outcome Measure

Overall Survival [ Time Frame: Up to Five Years ]

Central Contacts

Locations (36)

FacilityCityStateZIPSite coordinators
VA Loma Linda Healthcare SystemLoma LindaCalifornia92357-
Sutter Cancer Center SacramentoSacramentoCalifornia95816-
Rocky Mountain Cancer CentersDenverColorado80218-
Comprehensive Cancer Care and Research Institute of Colorado, CCCRICEnglewoodColorado80113-
Georgetown UniversityWashington D.C.District of Columbia20057-
Sibley Memorial Hospital - a member of Johns Hopkins medicineWashington D.C.District of Columbia20016-
21st Century OncologyFort MyersFlorida33907-
Miami Cancer CenterMiamiFlorida33167-
Sarasota Memorial Health Care SystemSarasotaFlorida34329-
Moffitt Cancer CenterTampaFlorida33612-
ASCLEPES Research CentersWeeki WacheeFlorida34607-
Piedmont-Columbus Regional - John B. Amos Cancer CenterColumbusGeorgia31904-
University of Iowa Hospitals and Clinics - Holden Comprehensive Cancer CenterIowa CityIowa52242-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
LSU Health ShreveportShreveportLouisiana71103-
Medstar Franklin SquareBaltimoreMaryland21237-
University of Nebraska Medical CenterOmahaNebraska68198-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03766-
MD Anderson Cancer Center at Cooper HospitalCamdenNew Jersey08103-
Atlantic Health System - Morristown Medical CenterMorristownNew Jersey07960-
Albany Stratton VA Medical CenterAlbanyNew York12208-
Feinstein Institutes for Medical Research - Northwell HealthManhassetNew York11030-
Columbia University Medical CenterNew YorkNew York10032-
Montefiore HospitalThe BronxNew York10461-
Levine Cancer Institute - Atrium HealthCharlotteNorth Carolina28204-
East Carolina UniversityGreenvilleNorth Carolina27834-
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-
Oklahoma University - Stephenson Cancer CenterOklahoma CityOklahoma73104-
Oregon Health & Science UniversityPortlandOregon97239-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
Medical University of South Carolina - Hollings Cancer CenterCharlestonSouth Carolina29425-
Prisma Health (formerly Greenville Health System)GreenvilleSouth Carolina29605-
Sarah Cannon Research InstituteNashvilleTennessee37203-
University of Texas Southwestern Medical CenterDallasTexas75390-
VA Puget Sound Health Care SystemSeattleWashington98108-
West Virginia University MedicineMorgantownWest Virginia26506-

Find similar trials in Loma Linda, CA

By research site
VA Loma Linda Healthcare System· Loma Linda, CASutter Cancer Center Sacramento· Sacramento, CARocky Mountain Cancer Centers· Denver, COComprehensive Cancer Care and Research Institute of Colorado, CCCRIC· Englewood, COGeorgetown University· Washington D.C., DCSibley Memorial Hospital - a member of Johns Hopkins medicine· Washington D.C., DC

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