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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
N/A
Not Enrolling
Both
Drug/Agent Toxicity by Tissue/Organ, Pancreatic Cancer

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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


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.

Inclusion 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

Type of Study:

Interventional

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:

No

Principal Investigator

Lenny Smith, MS

Investigator Role:

Study Chair

Investigator Affiliation:

Wellstat Therapeutics

Authority:

United States: Federal Government

Study ID:

CDR0000068931

NCT ID:

NCT00024427

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

Name

Location

CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Fox Chase - Temple Cancer CenterPhiladelphia, Pennsylvania  19111-2442
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Capitol Comprehensive Cancer Care ClinicJefferson City, Missouri  65109
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Scripps Cancer Center at Scripps ClinicLa Jolla, California  92037
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida  33021
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Cancer Care CenterNew Albany, Indiana  47150
Cancer Centers of the Carolinas - EastsideGreenville, South Carolina  29601
Cancer Center at Greater Baltimore Medical CenterBaltimore, Maryland  21204
Queens Medical Associates, PCFresh Meadows, New York  11365
Corpus Christi Cancer CenterCorpus Christi, Texas  78412
Brookwood Medical CenterBirmingham, Alabama  35209-6804
Northwest Oncology and Hematology AssociatesCoral Springs, Florida  33065
Florida Cancer Specialists - World PlazaFort Myers, Florida  33908
Florida Oncology Associates - South SideJacksonville, Florida  32207
Florida Cancer Institute - New Port RicheyNew Port Richey, Florida  34655
St. Joseph's HospitalSavannah, Georgia  31419
Wellstat TherapeuticsGaithersburg, Maryland  20878
Summit Oncology AssociatesAkron, Ohio  44304