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
  Purpose

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.


Condition Intervention Phase
Esophageal Neoplasms
Stomach Neoplasms
Adenocarcinoma
Drug: tezacitabine
Drug: 5-fluorouracil
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Chiron Corporation:

Study Start Date: November 2003
Estimated Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054873

  Show 29 Study Locations
Sponsors and Collaborators
Chiron Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00054873     History of Changes
Other Study ID Numbers: TEZ001
Study First Received: February 12, 2003
Last Updated: July 10, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Chiron Corporation:
Adenocarcinoma of the esophagus or stomach

Additional relevant MeSH terms:
Neoplasms
Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Fluorouracil
Tezacitabine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 30, 2014