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Triacetyluridine, Fluorouracil, and Leucovorin in Treating Patients With Unresectable, Locally Advanced, or Metastatic Cancer of the Esophagus or Stomach
This study is ongoing, but not recruiting participants.
First Received: January 28, 2000   Last Updated: October 18, 2008   History of Changes
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: Fluorouracil Leucovorin Citrovorum factor Leucovorin Calcium Folinic acid calcium salt pentahydrate
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2001
Detailed Description:

OBJECTIVES:

  • Assess the 6-month survival rate in patients with unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with triacetyluridine, fluorouracil, and leucovorin calcium.
  • Evaluate the qualitative and quantitative toxic effects of this regimen in these patients.

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
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction
  • No known brain metastases

    • Negative brain imaging required for neurologic signs and symptoms

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver tumor present)

Renal:

  • Creatinine no greater than ULN

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Must be able to swallow oral medication
  • No AIDS syndrome or HIV-associated complex
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy
  • No concurrent biologic therapy

Chemotherapy:

  • No prior chemotherapy for advanced or metastatic gastric cancer
  • At least 6 months since prior chemotherapy as adjuvant or radiation sensitizer

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 1 month since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery:

  • At least 3 weeks since prior major surgical resection of intra-abdominal organs and recovered
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004233

  Show 97 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: James H. Doroshow, MD Beckman Research Institute
  More Information

Additional Information:
Publications:
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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009