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COMPLETEDPHASE2

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

NCT00054873•Chiron Corporation

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.

Locations (29)

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

Key Dates

Start Date

November 1, 2003

Completion Date

December 1, 2004

Last Updated

July 11, 2006

Conditions

Esophageal NeoplasmsStomach NeoplasmsAdenocarcinoma

Interventions

tezacitabine

DRUG

5-fluorouracil

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2006Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

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IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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