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

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Brief Title

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

Official Title

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

Brief 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.
    

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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

Open Label Randomized Phase 3 Multi-Center Trial of PN401 plus high dose 5-FU versus Gemcitabine in Advanced Pancreatic Cancer Patients


Condition

Drug/Agent Toxicity by Tissue/Organ

Intervention

fluorouracil


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

250

Start Date

February 2001


Primary Completion Date

February 2006

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lenny Smith, MS, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00024427

Organization ID

CDR0000068931

Secondary IDs

WELLSTAT-401.00.001

Responsible Party

Sponsor

Study Sponsor

Wellstat Therapeutics


Study Sponsor

Lenny Smith, MS, Study Chair, Wellstat Therapeutics


Verification Date

May 2010