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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
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 |
|---|---|---|
|
Drug/Agent Toxicity by Tissue/Organ 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.
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| Study Chair: | James H. Doroshow, MD | Beckman Research Institute |
More Information
| Study ID Numbers: | CDR0000067477, SWOG-S9915 |
| Study First Received: | January 28, 2000 |
| Last Updated: | May 9, 2009 |
| 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 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 |