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Sponsored by: |
Wellstat Therapeutics |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00024427 |
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 |
---|---|---|
Cancer-Related Problem/Condition 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.
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:
Study Chair: | Lenny Smith, MS | Wellstat Therapeutics |
Study ID Numbers: | CDR0000068931, WELLSTAT-401.00.001, PRONEURON-401.00.001, UAB-0105, UAB-F010524008 |
Study First Received: | September 13, 2001 |
Last Updated: | October 18, 2008 |
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 Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Antiviral Agents Immunosuppressive Agents Pancrelipase Recurrence |
Digestive System Diseases Radiation-Sensitizing Agents Fluorouracil Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Endocrine Gland Neoplasms |
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 |