Clinical trial NCT00048529: Study of T900607-Sodium in Subjects With Previously Treated Gastric Cancer or Adenocarcinoma of the Esophagus
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Gastric Cancer
Esophageal Neoplasms
Keywords: adenocarcinoma of the esophagus
Lead sponsor: Tularik
Sponsor class: INDUSTRY
First posted: 2002-11-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Gatos
country: United States
facility: Pacific Oncology Associates
state: California
city: San Diego
country: United States
facility: Scripps Health Center
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Research and Treatment Center
state: New Mexico
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
Study officials:
name: Kerrie Boyd
role: STUDY_CHAIR
References: