Clinical trial NCT00054873: Tezacitabine With or Without 5-Fluorouracil (5-FU) for Advanced Esophageal Cancer or Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Neoplasms
Stomach Neoplasms
Adenocarcinoma
Keywords: Adenocarcinoma of the esophagus or stomach
Lead sponsor: Chiron Corporation
Sponsor class: INDUSTRY
First posted: 2003-02-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility 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.

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