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Ultrasound-Guided Photodynamic Therapy With Photofrin & Gemcitabine for Patients With Locally Advanced Pancreatic Cancer

NCT01770132 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-12-13

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of ultrasound-guided photodynamic therapy with porfimer sodium when given together with gemcitabine hydrochloride in treating patients with locally advanced pancreatic cancer. Photodynamic therapy uses a drug, porfimer sodium, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving photodynamic therapy together with gemcitabine hydrochloride may be effect in patients with pancreatic cancer.

Conditions

  • Acinar Cell Adenocarcinoma of the Pancreas
  • Duct Cell Adenocarcinoma of the Pancreas
  • Stage III Pancreatic Cancer

Interventions

DRUG

porfimer sodium

Given IV

PROCEDURE

endoscopic ultrasonography

Undergo EUS-PDT

PROCEDURE

photodynamic therapy

Undergo EUS-PDT

DRUG

gemcitabine hydrochloride

Given IV

Sponsors & Collaborators

  • American Society for Gastrointestinal Endoscopy

    collaborator OTHER

  • Pinnacle Biologics Inc.

    collaborator INDUSTRY

  • John DeWitt

    lead OTHER

Principal Investigators

  • John M DeWitt, MD · Indiana University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-19
Primary Completion
2017-07-13
Completion
2018-10-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01770132 on ClinicalTrials.gov