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

Completed · Phase 2

Conditions studied: Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT00054873

Run by

Chiron Corporation

Starts

2003-11-01

Expected to finish

2004-12-01

Last updated by the study team

2006-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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