Tezacitabine With or Without 5-Fluorouracil (5-FU) for Advanced Esophageal Cancer or Gastric Cancer
NCT ID: NCT00054873
Last Updated: 2006-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2003-11-30
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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tezacitabine
5-fluorouracil
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Chiron Corporation
INDUSTRY
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
ACRC/Arizona Clinical Research Center
Tucson, Arizona, United States
Glendale Memorial Hospital
Glendale, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Tower Hematology Oncology Medical Group
Los Angeles, California, United States
Comprehensive Cancer Center at DRMC
Palm Springs, California, United States
Desert Regional Medical Center
Palm Springs, California, United States
Sharp Clinical Oncology Research
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Cancer Institute Medical Group
Santa Monica, California, United States
Denver VAMC
Denver, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Memorial Regional Comprehensive Cancer Center
Weston, Florida, United States
Northwestern University, Feinberg School of Medicine, Division of Hematology/Oncology
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
LSU Health Sciences Center, Dept. of Medicine, Hematology/Oncology
Shreveport, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Josephine Ford Cancer Center, Henry Ford Health System
Detroit, Michigan, United States
Kansas City Oncology and Hematology Group
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
The Sarah Cannon Cancer Center, Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Countries
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Other Identifiers
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TEZ001
Identifier Type: -
Identifier Source: org_study_id