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

This study has been completed.

Sponsor:

Information provided by:

Chiron Corporation

ClinicalTrials.gov Identifier:

NCT00054873

First received: February 12, 2003

Last updated: July 10, 2006

Last verified: June 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	February 12, 2003
Last Updated Date	July 10, 2006
Start Date ^ICMJE	November 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00054873 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Tezacitabine With or Without 5-Fluorouracil (5-FU) for Advanced Esophageal Cancer or Gastric Cancer
Official Title ^ICMJE	Not Provided
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Esophageal Neoplasms Stomach Neoplasms Adenocarcinoma
Intervention ^ICMJE	Drug: tezacitabine Drug: 5-fluorouracil
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	December 2004
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00054873
Other Study ID Numbers ^ICMJE	TEZ001
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Chiron Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Chiron Corporation
Verification Date	June 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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