Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Triacetyluridine and High-Dose Fluorouracil Versus Gemcitabine in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care, Treatment	Closed	18 and over	Pharmaceutical / Industry	WELLSTAT-401.00.001 PRONEURON-401.00.001, UAB-0105, UAB-F010524008, NCT00024427

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable or evaluable disease
• No brain metastases
• No previous triacetyluridine
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. Patients in group one will receive an infusion of fluorouracil once a week for 3 weeks followed by 1 week of rest. At the same time they will also receive triacetyluridine by mouth 3 times a day for a total of eight doses. Patients in group two will receive an infusion of gemcitabine once a week for 7 weeks followed by 1 week of rest. After the first course, patients will receive an infusion of gemcitabine once a week for 3 weeks followed by one week of rest. Treatment in both groups may be repeated every 4 weeks for as long as benefit is shown. All patients will be evaluated periodically.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Wellstat Therapeutics

Lenny Smith, MS, Protocol chair		Ph: 240-631-2500 ext. 3238

Registry Information
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
Trial Start Date		2001-02-01
Registered in ClinicalTrials.gov		NCT00024427
Date Submitted to PDQ		2001-08-02
Information Last Verified		2005-05-25

Back to Top