Tezacitabine With or Without 5-Fluorouracil (5-FU) for Advanced Esophageal Cancer or Gastric Cancer

July 10, 2006 updated by: Chiron Corporation
The purpose of this study is to evaluate the efficacy and safety of tezacitabine when given alone or in combination with 5-fluorouracil (5-FU) to subjects who have advanced esophageal or gastric adenocarcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85712
        • ACRC/Arizona Clinical Research Center
    • California
      • Glendale, California, United States, 91204
        • Glendale Memorial Hospital
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90048
        • Tower Hematology Oncology Medical Group
      • Palm Springs, California, United States, 92262
        • Desert Regional Medical Center
      • Palm Springs, California, United States, 92262
        • Comprehensive Cancer Center at DRMC
      • San Diego, California, United States, 92123
        • Sharp Clinical Oncology Research
      • San Francisco, California, United States, 94115-1705
        • UCSF Comprehensive Cancer Center
      • Santa Monica, California, United States, 90404
        • Cancer Institute Medical Group
    • Colorado
      • Denver, Colorado, United States, 80220
        • Denver VAMC
    • Florida
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
      • Weston, Florida, United States, 33326
        • Memorial Regional Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Feinberg School of Medicine, Division of Hematology/Oncology
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • Shreveport, Louisiana, United States, 77130
        • LSU Health Sciences Center, Dept. of Medicine, Hematology/Oncology
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0922
        • University of Michigan Medical Center
      • Detroit, Michigan, United States, 48202
        • Josephine Ford Cancer Center, Henry Ford Health System
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City Oncology and Hematology Group
      • St. Louis, Missouri, United States, 63110
        • Washington University School of medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Cancer Center, Tennessee Oncology
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas, MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females greater than or equal to 18 years of age.
  • Histologically confirmed recurrent (inoperable) or metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or stomach.
  • At least one bidimensionally measurable lesion, not previously irradiated, with a diameter that meets RECIST criteria, that can be serially measured. Intraluminal tumors, evaluable only by endoscopy, are not acceptable as target lesions.
  • Karnofsky Performance Score greater than or equal to 70%.
  • Subjects must be in the second line therapy setting, thus they must have experienced progression following treatment with one (and only one) prior chemotherapy regimen used for the treatment of unresectable locally advanced, recurrent, or metastatic disease.
  • Recovery from any serious (grade 3 or higher) toxic effects of prior radiation therapy.
  • Adequate hematologic profile: absolute neutrophil count greater than or equal to 1,500/mm3; hemoglobin greater than or equal to 9 g/dL; hematocrit greater than or equal to 30% (transfusion allowed); and platelet count greater than or equal to 100,000/mm3.
  • Adequate hepatic function: bilirubin less than or equal to 1.5 mg/dL; AST and ALT less that 2.5 X ULN (5 X ULN if liver involved with tumor); alkaline phosphatase less than 5 X ULN
  • Adequate renal function; serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than 50 mL/min.
  • Both male and female subjects of childbearing potential must be using a contraceptive method that is medically acceptable to the investigative center.
  • Disease-free from a prior malignancy, other than non-melanoma skin cancer or carcinoma in-situ of the cervix, for greater than 5 years.

Exclusion Criteria:

  • Unstable angina or class III or IV New York Heart Association heart disease.
  • CNS metastases.
  • Pregnant or breast-feeding.
  • Uncontrolled seizure disorder.
  • Ongoing (grade 3 or higher) stomatitis, esophagopharyngitis, or uncontrolled diarrhea.
  • Impaired nutritional status as evidenced by a serum albumin of 2.7 mg/dL or less.
  • Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment. Concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiron Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

February 12, 2003

First Submitted That Met QC Criteria

February 12, 2003

First Posted (Estimate)

February 13, 2003

Study Record Updates

Last Update Posted (Estimate)

July 11, 2006

Last Update Submitted That Met QC Criteria

July 10, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEZ001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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