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| Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004233 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as triacetyluridine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of triacetyluridine, fluorouracil, and leucovorin in treating patients who have unresectable, locally advanced, or metastatic cancer of the esophagus or stomach.
| Condition | Intervention | Phase |
|
Cancer-Related Problem/Condition Esophageal Cancer Gastric Cancer |
Drug: fluorouracil Drug: leucovorin calcium Drug: triacetyluridine |
Phase II |
| MedlinePlus related topics: | Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer |
| Drug Information available for: | Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil Calcium gluconate |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of PN-401, 5-FU and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach |
| Study Start Date: | February 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 30 minutes beginning 1 hour into leucovorin calcium infusion on days 1, 8, 15, 22, 29, and 36. Patients receive oral triacetyluridine every 8 hours on days 1-3, 8-10, 15-17, 22-24, 29-31, and 36-38 beginning 8 hours after completion of each fluorouracil infusion. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No known brain metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations![]() |
Show 97 Study Locations |
| Southwest Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | James H. Doroshow, MD | Beckman Research Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067477, SWOG-S9915 |
| First Received: | January 28, 2000 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004233 |
| Health Authority: | United States: Federal Government |
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