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Study of T900607-Sodium in Subjects With Previously Treated Gastric Cancer or Adenocarcinoma of the Esophagus

This study has been suspended.

Sponsored by: Tularik
Information provided by: Tularik
ClinicalTrials.gov Identifier: NCT00048529
  Purpose

This is a clinical research study of T900607-sodium to determine if it is effective and safe in treating gastric cancer and adenocarcinoma of the esophagus. Patients will be treated on a weekly basis with an intravenous injection of the study drug.


Condition Intervention Phase
Gastric Cancer
Esophageal Neoplasms
Drug: T900607-sodium intravenous
Phase II

MedlinePlus related topics:   Cancer    Esophageal Cancer    Esophagus Disorders    Stomach Cancer   

ChemIDplus related topics:   T 900607   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Tularik:

Estimated Enrollment:   70
Study Start Date:   September 2002

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of gastric cancer or adenocarcinoma of the esophagus
  • Subjects must have received 1-2 regimens of prior chemotherapy
  • At least 18 years of age
  • Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size.
  • Karnofsky performance status of at least 70%
  • Estimated life expectancy of at least 12 weeks
  • Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive
  • Subject must be able to comply with study procedures and follow-up examinations.
  • Signed written informed consent
  • Lab Values (obtained ≤ 7 days prior to study enrollment):

    • ANC at least 1.5x10e9/L, * Platelet count at least 100x10e9/L,
    • Creatinine within 2 times upper limit of normal * AST and ALT within 5 times upper limit of normal
    • Bilirubin within 1.5 times upper limit of normal
    • Albumin great than 2.5 g/dL

Exclusion Criteria

  • Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment
  • NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of <50%, or acute anginal symptoms
  • Patients who have received any investigational agent within 4 weeks of enrollment
  • Patients who are pregnant or breast-feeding
  • History of prior malignancy other than gastric cancer or adenocarcinoma of the esophagus within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • History of central nervous system metastases or carcinomatous meningitis
  • Major surgery within 4 weeks of enrollment
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048529

Locations
United States, California
Pacific Oncology Associates    
      Los Gatos, California, United States, 95032
Scripps Health Center    
      San Diego, California, United States, 92137
United States, Florida
Moffitt Cancer Center    
      Tampa, Florida, United States, 33612
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center    
      Albuquerque, New Mexico, United States, 87131
United States, Ohio
Ireland Cancer Center    
      Cleveland, Ohio, United States, 44106

Sponsors and Collaborators
Tularik

Investigators
Study Chair:     Kerrie Boyd    
  More Information


Study ID Numbers:   T-607-006
First Received:   November 1, 2002
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00048529
Health Authority:   United States: Food and Drug Administration

Keywords provided by Tularik:
adenocarcinoma of the esophagus  

Study placed in the following topic categories:
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Stomach cancer
Carcinoma
Digestive System Diseases
Stomach Diseases
Stomach Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma
Esophageal neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 10, 2008




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