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

Stomach Neoplasms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054873
• Other study ID #: TEZ001
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2003
• Last updated: July 10, 2006
• Start date: November 2003
• Est. completion date: December 2004

Study information

• Verified date: June 2006
• Source: Chiron Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Neoplasms
• Stomach Neoplasms

Intervention

Drug:
• tezacitabine

• 5-fluorouracil

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University, Feinberg School of Medicine, Division of Hematology/Oncology	Chicago	Illinois
United States	The University of Chicago	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Denver VAMC	Denver	Colorado
United States	Josephine Ford Cancer Center, Henry Ford Health System	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Glendale Memorial Hospital	Glendale	California
United States	University of Texas, MD Anderson Cancer Center	Houston	Texas
United States	Kansas City Oncology and Hematology Group	Kansas City	Missouri
United States	Tower Hematology Oncology Medical Group	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	The Sarah Cannon Cancer Center, Tennessee Oncology	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Comprehensive Cancer Center at DRMC	Palm Springs	California
United States	Desert Regional Medical Center	Palm Springs	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
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	Swedish Cancer Institute	Seattle	Washington
United States	LSU Health Sciences Center, Dept. of Medicine, Hematology/Oncology	Shreveport	Louisiana
United States	Washington University School of Medicine	St. Louis	Missouri
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	ACRC/Arizona Clinical Research Center	Tucson	Arizona
United States	Memorial Regional Comprehensive Cancer Center	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Chiron Corporation

Country where clinical trial is conducted

United States,