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

Phase 2

Completed

• Conditions: Esophageal Neoplasms; Stomach Neoplasms; Adenocarcinoma

• Registration Number: NCT00054873
• Lead Sponsor: Chiron Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-02-12
• Study First Submitted QC: 2003-02-12
• Study First Posted: 2003-02-13
• Study Start: 2003-11
• Study Completion: 2004-12
• Status Verified: 2006-06
• Last Update Submitted: 2006-07-10
• Last Update Posted: 2006-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (29)

Tower Hematology Oncology Medical Group; 🇺🇸 Los Angeles, California, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

The University of Chicago; 🇺🇸 Chicago, Illinois, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Northwestern University, Feinberg School of Medicine, Division of Hematology/Oncology; 🇺🇸 Chicago, Illinois, United States

LSU Health Sciences Center, Dept. of Medicine, Hematology/Oncology; 🇺🇸 Shreveport, Louisiana, United States

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Kansas City Oncology and Hematology Group; 🇺🇸 Kansas City, Missouri, United States

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States

Comprehensive Cancer Center at DRMC; 🇺🇸 Palm Springs, California, United States

University of Texas, MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Denver VAMC; 🇺🇸 Denver, Colorado, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Josephine Ford Cancer Center, Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Cancer Institute Medical Group; 🇺🇸 Santa Monica, California, United States

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Glendale Memorial Hospital; 🇺🇸 Glendale, California, United States

ACRC/Arizona Clinical Research Center; 🇺🇸 Tucson, Arizona, United States

Sharp Clinical Oncology Research; 🇺🇸 San Diego, California, United States

Desert Regional Medical Center; 🇺🇸 Palm Springs, California, United States

Memorial Regional Comprehensive Cancer Center; 🇺🇸 Weston, Florida, United States

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

The Sarah Cannon Cancer Center, Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States