check_circleStudy Completed

Carcinoma, Hepatocellular

Bayer Identifier:

11546

ClinicalTrials.gov Identifier:

NCT00108953

EudraCT Number:

2004-001770-40

EU CT Number:

Not Available
A Research Study to Treat Patients with Advanced Hepatocellular Carcinoma

Trial purpose

The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC).

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Patients who have a life expectancy of at least 12 weeks
    - Patients with advanced HCC (unresectable, and/or metastatic) which has been histologically or cytologically documented
    - Patients must have at least one tumor lesion that meets both of the following criteria:
     -- can be accurately measured in at least one dimension according to Response Evaluation Criteria in Solid Tumors (RECIST)
     -- has not been previously treated with local therapy
    - Patients who have received local therapy except chemoembolization, such as surgery, radiation therapy, hepatic arterial embolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of 25% in the size. Local therapy must be completed at least 4 weeks prior to the baseline scan
    - Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • - Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted
    - History of cardiac disease
    - Serious myocardial dysfunction
    - Active, clinically serious infections
    - Known history of Human Immunodeficiency Virus (HIV) infection
    - Known Central Nervous System (CNS) tumors including metastatic brain disease
    - Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

Trial summary

Enrollment Goal
96
Trial Dates
April 2005 - April 2008
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Clatterbridge Centre for OncologyBebington, CH63 4JY, United Kingdom
Completed
Christie HospitalManchester, M20 4BX, United Kingdom
Completed
Kent Oncology CentreMaidstone, ME16 9QQ, United Kingdom
Completed
VA Palo Alto Health Care SystemPalo Alto, 94304-1207, United States
Completed
California Pacific Medical CenterSan Francisco, 94115, United States
Completed
Hackensack University Medical CenterHackensack, 07601, United States
Completed
University of Rochester Medical CenterRochester, 14642, United States
Completed
Veterans Affairs Medical Center-San FranciscoSan Francisco, 94121, United States
Completed
Princess Margaret Hospital-University Health NetworkToronto, M5G 2M9, Canada
Completed
Unidad Oncológica de NeuquénNeuquen, Q8300HDH, Argentina
Completed
Hosp. Mun. de Gastroenterología Dr. Carlos Bonorino UdaondoBuenos Aires, C1264AAA, Argentina
Completed
Oncology Centre of Kazan State Medical UniversityKazan, 420111, Russia
Completed
Krasnodar City Oncology CenterKrasnodar, 350040, Russia
Completed
Kirov State Medical AcademyKirov, 610002, Russia
Completed
University of BirminghamBirmingham, B15 2TT, United Kingdom
Completed
Hammersmith HospitalLondon, W12 0HS, United Kingdom
Completed
Memorial Sloan-Kettering Cancer CenterNew York, 10065, United States
Completed
University of Miami School of MedicineMiami, 33136, United States
Completed
University of MinnesotaMinneapolis, 55455, United States
Completed
Sarah Cannon Cancer CenterNashville, 37203, United States
Completed
Tower Hematology/Oncology Medical GroupBeverly Hills, 90211-1850, United States
Completed
Virginia Mason Medical CenterSeattle, 98101, United States
Completed
UCLA Medical Center-Olive ViewSylmar, 91342, United States
Completed
UC Irvine Medical CenterOrange, 92668-3298, United States
Completed
Louisiana Oncology Associates, PMCLafayette, 70506, United States
Completed
University of Alabama at BirminghamBirmingham, 35294, United States
Completed
Hospital BritánicoBuenos Aires, Argentina
Completed
Hong Kong, Hong Kong

Primary Outcome

  • Time to Progression (TTP)
    date_rangeTime Frame:
    from date of randomization of the first patient until 3 years later
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall Survival
    date_rangeTime Frame:
    from date of randomization of the first patient until 3 years later
    enhanced_encryption
    Safety Issue:
    No
  • Progression Free Survival (PFS)
    date_rangeTime Frame:
    from date of randomization of the first patient until 3 years later
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Participants in Each Category of Best Tumor Response
    date_rangeTime Frame:
    achieved during treatment or within 30 days after termination of active therapy
    enhanced_encryption
    Safety Issue:
    No
  • Time to Symptomatic Progression (TTSP)
    date_rangeTime Frame:
    from date of randomization of the first patient until 3 years later
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Response
    date_rangeTime Frame:
    from date of randomization of the first patient until 3 years later
    enhanced_encryption
    Safety Issue:
    No
  • Time to Response (TTR)
    date_rangeTime Frame:
    from date of randomization until 3 years later at end of study
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Participants for Whom Disease Control Was Achieved
    date_rangeTime Frame:
    from date of randomization to end of treatment plus 30 days
    enhanced_encryption
    Safety Issue:
    No

Trial design

A randomized controlled study of BAY43-9006 in combination with doxorubicin versus doxorubicin in patients with advanced hepatocellular carcinoma.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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