Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by Tularik.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Tularik
ClinicalTrials.gov Identifier:
NCT00043433
First received: August 8, 2002
Last updated: June 23, 2005
Last verified: April 2004
  Purpose

The purpose of the study is to determine whether T900607-sodium is effective and safe in treating hepatocellular carcinoma, a type of liver cancer.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: intravenous T900607-sodium
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: 35
Study Start Date: July 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 HCC
  • Child-Pugh liver classification of A or B
  • Subjects must not have received prior chemotherapy or radiotherapy for their HCC
  • 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 2.8 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 cancer studied 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
  • Patients who have received prior chemotherapy, chemoembolization, immunotherapy, or radiotherapy for their HCC. Prior surgical resection, intratumoral ethanol injection, hormonal therapy, cryosurgery, radiofrequency ablation, selective internal radiation or embolization, is permitted ONLY if > 6 weeks has passed since therapy and there is an indicator lesion (> 1 x 1 cm) outside the area of prior treatment (recurrence at the margin or resection is allowed)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043433

Locations
United States, California
Scripps Health Center
La Jolla, California, United States, 92037
University of California San Diego
La Jolla, California, United States, 92093
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Missouri
Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
China
Queen Mary Hospital
Hong Kong, China
Sponsors and Collaborators
Tularik
Investigators
Study Chair: Charlene Sum Tularik
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00043433     History of Changes
Other Study ID Numbers: T-607-004
Study First Received: August 8, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Tularik:
HCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 15, 2014