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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

Phase 3
18 Years
Not Enrolling
Drug/Agent Toxicity by Tissue/Organ, Pancreatic Cancer

Thank you

Trial Information

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


- Compare the survival of patients with unresectable locally advanced or metastatic
pancreatic cancer treated with triacetyluridine and high-dose fluorouracil vs

- 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

- 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

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.

Inclusion Criteria


- 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

- No carcinoid, islet cell, or lymphoma of the pancreas

- No prior or concurrent brain or leptomeningeal metastases



- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- At least 3 months


- WBC at least 3,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9.5 g/dL


- 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


- Creatinine less than 2.0 mg/dL

- No uncontrolled renal dysfunction


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

- Angina

- Arrhythmias

- Uncompensated cardiac failure

- Myocardial infarction within the past 6 months


- No uncontrolled pulmonary dysfunction


- Able to take and/or retain oral medication

- No uncontrolled malabsorption syndrome or any other condition that would interfere
with intestinal absorption


- 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

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative


Biologic therapy:

- No concurrent biologic therapy (including immunotherapy) for cancer


- 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


- Prior radiotherapy allowed

- No concurrent radiotherapy


- See Disease Characteristics

- Prior resection of pancreas allowed


- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Disease progression

Safety Issue:


Principal Investigator

Lenny Smith, MS

Investigator Role:

Study Chair

Investigator Affiliation:

Wellstat Therapeutics


United States: Federal Government

Study ID:




Start Date:

February 2001

Completion Date:

Related Keywords:

  • Drug/Agent Toxicity by Tissue/Organ
  • Pancreatic Cancer
  • drug/agent toxicity by tissue/organ
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms



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