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

February 12, 2003
July 10, 2006
November 2003
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Complete list of historical versions of study NCT00054873 on ClinicalTrials.gov Archive Site
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Tezacitabine With or Without 5-Fluorouracil (5-FU) for Advanced Esophageal Cancer or Gastric Cancer
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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.

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Interventional
Phase 2
Primary Purpose: Treatment
  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Adenocarcinoma
  • Drug: tezacitabine
  • Drug: 5-fluorouracil
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2004
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00054873
TEZ001
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Chiron Corporation
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Chiron Corporation
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP