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

This study has been completed.
Sponsor:
Information provided by:
Chiron Corporation
ClinicalTrials.gov Identifier:
NCT00054873
First received: February 12, 2003
Last updated: July 10, 2006
Last verified: June 2006
  Purpose

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.


Condition Intervention Phase
Esophageal Neoplasms
Stomach Neoplasms
Adenocarcinoma
Drug: tezacitabine
Drug: 5-fluorouracil
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Chiron Corporation:

Study Start Date: November 2003
Estimated Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054873

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

No publications provided

ClinicalTrials.gov Identifier: NCT00054873     History of Changes
Other Study ID Numbers: TEZ001
Study First Received: February 12, 2003
Last Updated: July 10, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Chiron Corporation:
Adenocarcinoma of the esophagus or stomach

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Neoplasms
Stomach Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Stomach Diseases
Fluorouracil
Tezacitabine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014