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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Tularik
ClinicalTrials.gov Identifier:
NCT00048529
First received: November 1, 2002
Last updated: June 23, 2005
Last verified: April 2004
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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
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: 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

No publications provided

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

Keywords provided by Tularik:
adenocarcinoma of the esophagus

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Esophageal Neoplasms
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on August 27, 2014