T138067 Versus Doxorubicin in Chemotherapy-Naive, Unresectable, Hepatocellular Carcinoma Patients

This study has been terminated.
Sponsor:
Information provided by:
Tularik
ClinicalTrials.gov Identifier:
NCT00057382
First received: March 31, 2003
Last updated: June 23, 2005
Last verified: September 2004
  Purpose

This is an international, multicenter, randomized study of intravenous T138067 versus intravenous doxorubicin in hepatocellular carcinoma (liver cancer). Patients can not have been treated before with chemotherapy and surgery is not recommended for their cancer. A total of 750 subjects will be enrolled in this study.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: T138067 intravenous
Drug: doxorubicin intravenous
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Tularik:

Estimated Enrollment: 750
Study Start Date: March 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key inclusion criteria include:

  • pathologic diagnosis of unresectable HCC
  • chemotherapy-naïve for HCC
  • Child-Pugh Class A or B liver disease
  • measurable disease (i.e., at least one lesion that is at least 20 mm in one dimension) on computerized tomography (CT) scan or magnetic resonance imaging (MRI) or at least one lesion that is at least 10 mm on spiral CT scan
  • Karnofsky Performance Status of ≥ 70%
  • life expectancy of ≥ 12 weeks
  • adequate hematologic function (i.e., absolute neutrophil count [ANC] of ≥ 1500 cells/mm3, platelet count of ≥ 80,000 cells/mm3, hemoglobin of ≥ 8.5 g/dL)
  • total bilirubin of ≤ 1.5 upper limit of normal (ULN)
  • aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 5 ULN
  • serum creatinine of ≤ 2 x ULN

Key exclusion criteria include:

  • severe, concurrent disease that would make the subject inappropriate for enrollment
  • Subjects who have received prior intravenous or intra-arterial chemotherapy, chemoembolization, intratumoral ethanol injection, cryosurgery, radiofrequency ablation, or embolization for their HCC. (note: prior surgical resection, immunotherapy, hormonal therapy, radiotherapy, and/or orthotopic liver transplantation are allowed)
  • history of other cancer within the past 5 years other than adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
  • New York Heart Association (NYHA) class III or IV heart disease or a left ventricular ejection fraction of <50% or acute anginal symptoms
  • females who are pregnant or breast-feeding
  • received any investigational agent within 4 weeks of enrollment
  • history of central nervous system metastases or carcinomatous meningitis
  • clinically apparent ascites
  • major surgery within 4 weeks of study 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: NCT00057382

  Show 76 Study Locations
Sponsors and Collaborators
Tularik
Investigators
Study Director: Mohammad Hirmand, MD Tularik
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00057382     History of Changes
Obsolete Identifiers: NCT00066287
Other Study ID Numbers: T-067-010
Study First Received: March 31, 2003
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Tularik:
liver cancer

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
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014