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

Tracking Information

First Received Date ^ICMJE

March 31, 2003

Last Updated Date

June 23, 2005

Start Date ^ICMJE

March 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00057382 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hepatocellular Carcinoma

Intervention ^ICMJE

Drug: T138067 intravenous
Drug: doxorubicin intravenous

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

750

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Brazil, China, Poland, Puerto Rico, Russian Federation, Singapore, South Africa, Thailand, Ukraine, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00057382

Responsible Party

Study ID Numbers ^ICMJE

T-067-010

Study Sponsor ^ICMJE

Tularik

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Mohammad Hirmand, MD

Tularik

Information Provided By

Tularik

Verification Date

September 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP