NCT00024427

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
2 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2001

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Last Updated

June 28, 2012

Status Verified

May 1, 2010

Enrollment Period

5 years

First QC Date

September 13, 2001

Last Update Submit

June 27, 2012

Conditions

Drug/Agent Toxicity by Tissue/OrganPancreatic Cancer

Keywords

drug/agent toxicity by tissue/organstage II pancreatic cancerstage III pancreatic cancerrecurrent pancreatic canceradenocarcinoma of the pancreasstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

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

    Disease progression

Interventions

fluorouracilDRUG

High dose 5-FU

Also known as: 5-FU
gemcitabine hydrochlorideDRUG

Normal dose to treat pancreatic cancer

Also known as: Gemzar
triacetyluridineDRUG

6 grams (12 tablets)

Also known as: 2',3',5'tri-O-acetyluridine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (29)

Brookwood Medical Center

Birmingham, Alabama, 35209-6804, United States

Location

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Providence Saint Joseph Medical Center - Burbank

Burbank, California, 91505, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Scripps Cancer Center at Scripps Clinic

La Jolla, California, 92037, United States

Location

Northwest Oncology and Hematology Associates

Coral Springs, Florida, 33065, United States

Location

Florida Cancer Specialists - World Plaza

Fort Myers, Florida, 33908, United States

Location

Memorial Cancer Institute at Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Florida Oncology Associates - South Side

Jacksonville, Florida, 32207, United States

Location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Florida Cancer Institute - New Port Richey

New Port Richey, Florida, 34655, United States

Location

St. Joseph's Hospital

Savannah, Georgia, 31419, United States

Location

Cancer Care Center

New Albany, Indiana, 47150, United States

Location

Cancer Center at Greater Baltimore Medical Center

Baltimore, Maryland, 21204-6881, United States

Location

Wellstat Therapeutics

Gaithersburg, Maryland, 20878, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Capitol Comprehensive Cancer Care Clinic

Jefferson City, Missouri, 65109, United States

Location

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, 63141, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131-5636, United States

Location

Queens Medical Associates, PC

Fresh Meadows, New York, 11365, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Summit Oncology Associates

Akron, Ohio, 44304, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Fox Chase - Temple Cancer Center

Philadelphia, Pennsylvania, 19140, United States

Location

Cancer Centers of the Carolinas - Eastside

Greenville, South Carolina, 29615, United States

Location

Corpus Christi Cancer Center

Corpus Christi, Texas, 78412, United States

Location

Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 1C4, Canada

Location

Regional Cancer Care at Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

McGill Cancer Centre at McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsPancreatic Neoplasms

Interventions

FluorouracilGemcitabineuridine triacetate

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine Nucleosides

Study Officials

  • Lenny Smith, MS

    Wellstat Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2001

First Posted

January 27, 2003

Study Start

February 1, 2001

Primary Completion

February 1, 2006

Last Updated

June 28, 2012

Record last verified: 2010-05

Locations

CA(3)US(26)