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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



CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Fox Chase - Temple Cancer Center Philadelphia, Pennsylvania  19111-2442
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136
University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico  87131
City of Hope Comprehensive Cancer Center Duarte, California  91010
Capitol Comprehensive Cancer Care Clinic Jefferson City, Missouri  65109
Comprehensive Cancer Center at University of Alabama at Birmingham Birmingham, Alabama  35294
Scripps Cancer Center at Scripps Clinic La Jolla, California  92037
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Memorial Cancer Institute at Memorial Regional Hospital Hollywood, Florida  33021
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Cancer Care Center New Albany, Indiana  47150
Cancer Centers of the Carolinas - Eastside Greenville, South Carolina  29601
Cancer Center at Greater Baltimore Medical Center Baltimore, Maryland  21204
Queens Medical Associates, PC Fresh Meadows, New York  11365
Corpus Christi Cancer Center Corpus Christi, Texas  78412
Brookwood Medical Center Birmingham, Alabama  35209-6804
Northwest Oncology and Hematology Associates Coral Springs, Florida  33065
Florida Cancer Specialists - World Plaza Fort Myers, Florida  33908
Florida Oncology Associates - South Side Jacksonville, Florida  32207
Florida Cancer Institute - New Port Richey New Port Richey, Florida  34655
St. Joseph's Hospital Savannah, Georgia  31419
Wellstat Therapeutics Gaithersburg, Maryland  20878
Summit Oncology Associates Akron, Ohio  44304