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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004233 |
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 |
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Cancer-Related Problem/Condition Esophageal Cancer Gastric Cancer |
Drug: fluorouracil Drug: leucovorin calcium Drug: triacetyluridine |
Phase II |
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.
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:
Study Chair: | James H. Doroshow, MD | Beckman Research Institute |
Study ID Numbers: | CDR0000067477, SWOG-S9915 |
Study First Received: | January 28, 2000 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00004233 History of Changes |
Health Authority: | United States: Federal Government |
drug/agent toxicity by tissue/organ stage III gastric cancer stage IV gastric cancer recurrent gastric cancer stage III esophageal cancer |
stage IV esophageal cancer recurrent esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus |
Antimetabolites Immunologic Factors Gastrointestinal Diseases Esophageal Neoplasms Leucovorin Stomach Diseases Stomach Neoplasms Vitamins Neoplasm Metastasis Micronutrients Digestive System Neoplasms Vitamin B Complex Trace Elements Esophageal Cancer |
Immunosuppressive Agents Recurrence Carcinoma Calcium, Dietary Digestive System Diseases Esophageal Disorder Head and Neck Neoplasms Fluorouracil Gastrointestinal Neoplasms Esophageal Diseases Stomach Cancer Adenocarcinoma Neoplasms, Glandular and Epithelial |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Physiological Effects of Drugs Leucovorin Neoplasms by Site Stomach Diseases Vitamins Stomach Neoplasms Therapeutic Uses Micronutrients |
Vitamin B Complex Digestive System Neoplasms Neoplasms by Histologic Type Growth Substances Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Head and Neck Neoplasms Fluorouracil Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |