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Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer

NCT00024427 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2012-06-28

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells. Chemoprotective drugs such as triacetyluridine may protect normal cells from the side effects of chemotherapy. It is not yet known which chemotherapy regimen is more effective in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus triacetyluridine with that of gemcitabine in treating patients who have locally advanced or metastatic pancreatic cancer that cannot be treated with surgery.

Conditions

Interventions

DRUG

fluorouracil

High dose 5-FU

DRUG

gemcitabine hydrochloride

Normal dose to treat pancreatic cancer

DRUG

triacetyluridine

6 grams (12 tablets)

Sponsors & Collaborators

  • Wellstat Therapeutics

    lead INDUSTRY

Principal Investigators

  • Lenny Smith, MS · Wellstat Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2006-02-28

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00024427 on ClinicalTrials.gov