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| Sponsor: | Wellstat Therapeutics |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00024427 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug/Agent Toxicity by Tissue/Organ Pancreatic Cancer |
Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: triacetyluridine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| 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 |
| Study Start Date: | February 2001 |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Unresectable locally advanced or metastatic disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No uncontrolled cardiovascular disease requiring therapy, including the following:
Pulmonary:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Brookwood Medical Center | |
| Birmingham, Alabama, United States, 35209-6804 | |
| Comprehensive Cancer Center at University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Providence Saint Joseph Medical Center - Burbank | |
| Burbank, California, United States, 91505 | |
| Scripps Cancer Center at Scripps Clinic | |
| La Jolla, California, United States, 92037 | |
| United States, Florida | |
| Florida Cancer Institute - New Port Richey | |
| New Port Richey, Florida, United States, 34655 | |
| Florida Cancer Specialists - World Plaza | |
| Fort Myers, Florida, United States, 33908 | |
| Florida Oncology Associates - South Side | |
| Jacksonville, Florida, United States, 32207 | |
| Memorial Cancer Institute at Memorial Regional Hospital | |
| Hollywood, Florida, United States, 33021 | |
| Northwest Oncology and Hematology Associates | |
| Coral Springs, Florida, United States, 33065 | |
| University of Miami Sylvester Comprehensive Cancer Center | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| St. Joseph's Hospital | |
| Savannah, Georgia, United States, 31419 | |
| United States, Indiana | |
| Cancer Care Center | |
| New Albany, Indiana, United States, 47150 | |
| United States, Maryland | |
| Cancer Center at Greater Baltimore Medical Center | |
| Baltimore, Maryland, United States, 21204-6881 | |
| Wellstat Therapeutics | |
| Gaithersburg, Maryland, United States, 20878 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United States, Missouri | |
| Capitol Comprehensive Cancer Care Clinic | |
| Jefferson City, Missouri, United States, 65109 | |
| David C. Pratt Cancer Center at St. John's Mercy | |
| Saint Louis, Missouri, United States, 63141 | |
| United States, New Mexico | |
| University of New Mexico Cancer Research and Treatment Center | |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| United States, New York | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| Queens Medical Associates, PC | |
| Fresh Meadows, New York, United States, 11365 | |
| United States, Ohio | |
| Summit Oncology Associates | |
| Akron, Ohio, United States, 44304 | |
| United States, Pennsylvania | |
| Fox Chase - Temple Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas - Eastside | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Texas | |
| Corpus Christi Cancer Center | |
| Corpus Christi, Texas, United States, 78412 | |
| Canada, Ontario | |
| Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Regional Cancer Care at Thunder Bay Regional Health Sciences Centre | |
| Thunder Bay, Ontario, Canada, P7B 6V4 | |
| Canada, Quebec | |
| McGill Cancer Centre at McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Study Chair: | Lenny Smith, MS | Wellstat Therapeutics |
More Information
| Study ID Numbers: | CDR0000068931, WELLSTAT-401.00.001, PRONEURON-401.00.001, UAB-0105, UAB-F010524008 |
| Study First Received: | September 13, 2001 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00024427 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors Antiviral Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Fluorouracil Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |