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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00048529
Recruitment Status : Suspended
First Posted : November 4, 2002
Last Update Posted : June 24, 2005
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Gastric Cancer Esophageal Neoplasms Drug: T900607-sodium intravenous Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00048529

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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
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Study Chair: Kerrie Boyd
Layout table for additonal information Identifier: NCT00048529    
Other Study ID Numbers: T-607-006
First Posted: November 4, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2004
Keywords provided by Tularik:
adenocarcinoma of the esophagus
Additional relevant MeSH terms:
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Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases