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

June 27, 2012 updated by: Wellstat Therapeutics

An Open Label, Randomized, Controlled, Phase III, Multi-center, Clinical Trial Of PN401 With High Dose 5-Fluorouracil (5FU) Versus Gemcitabine For Treatment Of Patients With Advanced Pancreatic Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the survival of patients with unresectable locally advanced or metastatic pancreatic cancer treated with triacetyluridine and high-dose fluorouracil vs gemcitabine.
  • Compare the time to tumor progression, overall response rate, and response duration in patients treated with these regimens.
  • Compare the safety of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to disease stage (II or III vs IV). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive high-dose fluorouracil (5-FU) IV over 30 minutes once weekly on weeks 1-3 followed by 1 week of rest. After each dose of 5-FU, patients receive oral triacetyluridine every 8 hours for a total of 8 doses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 followed by 1 week of rest (course 1). Subsequent courses are given on weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 260 patients (130 per treatment arm) will be accrued for this study within 30 months.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill Cancer Centre at McGill University
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Comprehensive Cancer Center at University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35209-6804
        • Brookwood Medical Center
    • California
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center - Burbank
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • La Jolla, California, United States, 92037
        • Scripps Cancer Center at Scripps Clinic
    • Florida
      • Coral Springs, Florida, United States, 33065
        • Northwest Oncology and Hematology Associates
      • Fort Myers, Florida, United States, 33908
        • Florida Cancer Specialists - World Plaza
      • Hollywood, Florida, United States, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Jacksonville, Florida, United States, 32207
        • Florida Oncology Associates - South Side
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center
      • New Port Richey, Florida, United States, 34655
        • Florida Cancer Institute - New Port Richey
    • Georgia
      • Savannah, Georgia, United States, 31419
        • St. Joseph's Hospital
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Cancer Care Center
    • Maryland
      • Baltimore, Maryland, United States, 21204-6881
        • Cancer Center At Greater Baltimore Medical Center
      • Gaithersburg, Maryland, United States, 20878
        • Wellstat Therapeutics
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Capitol Comprehensive Cancer Care Clinic
      • Saint Louis, Missouri, United States, 63141
        • David C. Pratt Cancer Center at St. John's Mercy
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-5636
        • University of New Mexico Cancer Research and Treatment Center
    • New York
      • Fresh Meadows, New York, United States, 11365
        • Queens Medical Associates, PC
      • New York, New York, United States, 10021
        • New York Weill Cornell Cancer Center at Cornell University
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summit Oncology Associates
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19140
        • Fox Chase - Temple Cancer Center
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Cancer Centers of the Carolinas - Eastside
    • Texas
      • Corpus Christi, Texas, United States, 78412
        • Corpus Christi Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas

    • Unresectable locally advanced or metastatic disease

      • Stage II, III, or IV
  • Measurable or evaluable disease
  • No elevated tumor marker (CA 19-9) only
  • No clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion)
  • No carcinoid, islet cell, or lymphoma of the pancreas
  • No prior or concurrent brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC at least 3,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.5 g/dL

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • ALT or AST less than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • No uncontrolled hepatic dysfunction

Renal:

  • Creatinine less than 2.0 mg/dL
  • No uncontrolled renal dysfunction

Cardiovascular:

  • No uncontrolled cardiovascular disease requiring therapy, including the following:

    • Angina
    • Arrhythmias
    • Uncompensated cardiac failure
    • Myocardial infarction within the past 6 months

Pulmonary:

  • No uncontrolled pulmonary dysfunction

Gastrointestinal:

  • Able to take and/or retain oral medication
  • No uncontrolled malabsorption syndrome or any other condition that would interfere with intestinal absorption

Other:

  • No known allergy to fluorouracil (5-FU), gemcitabine, triacetyluridine, or any of their components
  • No dihydropyrimidine-dehydrogenase deficiency
  • No active uncontrolled infection
  • No uncontrolled neurologic or psychiatric dysfunction
  • No other malignancy except previously resected basal cell cancer or curatively resected stage I or less cervical cancer that has been disease free for at least 5 years
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biologic therapy (including immunotherapy) for cancer

Chemotherapy:

  • No prior chemotherapy for cancer other than as a radiosensitizer
  • No prior 5-FU or gemcitabine other than as a radiosensitizer
  • No prior triacetyluridine
  • No other concurrent chemotherapy (including leucovorin calcium) for cancer

Endocrine therapy:

  • No concurrent hormonal therapy for cancer
  • Concurrent megestrol, oral contraceptives, or postmenopausal estrogen replacement therapy allowed

Radiotherapy:

  • Prior radiotherapy allowed
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • Prior resection of pancreas allowed

Other:

  • At least 30 days since prior investigational drug or therapeutic device
  • No other concurrent anticancer therapy
  • No other concurrent investigational drugs or devices
  • No concurrent drugs that would interact adversely with 5-FU or gemcitabine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Open Label Randomized Phase 3 Multi-Center Trial of PN401 plus high dose 5-FU versus Gemcitabine in Advanced Pancreatic Cancer Patients
Time Frame: Disease progression
Disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wellstat Therapeutics

Investigators

  • Study Chair: Lenny Smith, MS, Wellstat Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

September 13, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 28, 2012

Last Update Submitted That Met QC Criteria

June 27, 2012

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068931
  • WELLSTAT-401.00.001
  • PRONEURON-401.00.001
  • UAB-0105
  • UAB-F010524008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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