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

NCT00048529 | Suspended Phase 2

• 1 other identifier: T-607-006
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 5

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.

Conditions

Gastric Cancer; Esophageal Neoplasms

Keywords

adenocarcinoma of the esophagus

Interventions

T900607-sodium intravenous DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tularik: lead

Study Sites (5)

Pacific Oncology Associates

Los Gatos, California, 95032, United States

Location

Scripps Health Center

San Diego, California, 92137, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases

Study Officials

• Kerrie Boyd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 2002
• First Posted: November 4, 2002
• Study Start: September 1, 2002
• Last Updated: June 24, 2005

Record last verified: 2004-04

Locations

US (5)