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A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00108953
Recruitment Status : Completed
First Posted : April 22, 2005
Results First Posted : June 11, 2009
Last Update Posted : October 31, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin Drug: Doxorubicin/Placebo Phase 2

Detailed Description:

In addition to the key secondary outcome parameters the following parameters will be assessed in an exploratory manner: relative time to progression (TTP), time to symptomatic progression (TTSP), response rate (RR) and overall survival between the 2 study populations.

The possible and potential predictive assays of clinical benefit through an assessment of the correlation between the defined baseline characteristics and key clinical endpoints.

The safety and tolerability will be assessed in the adverse event section. Doxorubicin pharmacokinetics in HCC patients treated with sorafenib versus placebo will be compared and the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e., cardiotoxicity).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.
Study Start Date : April 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sorafenib + Doxorubicin
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
 Drug: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin
Multi kinase inhibitor plus Chemotherapy
Active Comparator: Placebo + Doxorubicin
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
 Drug: Doxorubicin/Placebo
Chemotherapy plus Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Time to Progression (TTP) [ Time Frame: from date of randomization of the first patient until 3 years later ]
    TTP was defined as the time from randomization to radiological disease progression by independent assessment.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: from date of randomization of the first patient until 3 years later ]
    The time from date of randomization to date of death

  2. Progression Free Survival (PFS) [ Time Frame: from date of randomization of the first patient until 3 years later ]
    Time from the date of randomization to the date of the first documented radiological progression (as defined per independent central radiological assessment) or death, whichever occurs first

  3. Percentage of Participants in Each Category of Best Tumor Response [ Time Frame: achieved during treatment or within 30 days after termination of active therapy ]
    Percentage of participants with complete or partial response (CR or PR) confirmed according to Response Evaluation Criteria in Solid Tumors (RECIST) and achieved during treatment or 30 days after end of treatment. CR: disappearance of all clinical and radiological tumor lesions. PR: at least 30% decrease in sum of the longest diameters of tumor lesions. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.

  4. Time to Symptomatic Progression (TTSP) [ Time Frame: from date of randomization of the first patient until 3 years later ]
    Time from date of randomization to date of first documented symptomatic progression defined by Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index-8 (FHSI-8) assessment

  5. Duration of Response [ Time Frame: from date of randomization of the first patient until 3 years later ]
    Time from date of first objective response (complete response [CR] or partial response [PR]) to date progression is first documented (as defined per independent central radiological assessment) or death, whichever occurs first

  6. Time to Response (TTR) [ Time Frame: from date of randomization until 3 years later at end of study ]
    Time from date of randomization to date of first objective response (complete response [CR] or partial response [PR]) is documented and confirmed according to RECIST criteria

  7. Percentage of Participants for Whom Disease Control Was Achieved [ Time Frame: from date of randomization to end of treatment plus 30 days ]
    Participants with disease control: those who have as best response complete response (CR), partial response (PR) or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease) according to Response Evaluation Criteria in Solid Tumors (RECIST)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108953


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35294
United States, California
Beverly Hills, California, United States, 90211-1850
Orange, California, United States, 92668-3298
Palo Alto, California, United States, 94304-1207
San Francisco, California, United States, 94115
San Francisco, California, United States, 94121
Sylmar, California, United States, 91342
United States, Florida
Miami, Florida, United States, 33136
United States, Louisiana
Lafayette, Louisiana, United States, 70506
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
Hackensack, New Jersey, United States, 07601
United States, New York
New York, New York, United States, 10065
Rochester, New York, United States, 14642
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Washington
Seattle, Washington, United States, 98101
Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1264AAA
Neuquen, Neuquén, Argentina, Q8300HDH
Buenos Aires, Argentina
Canada, Ontario
Toronto, Ontario, Canada, M5G 2M9
Hong Kong
Hong Kong, Hong Kong
Russian Federation
Kazan, Russian Federation, 420111
Kirov, Russian Federation, 610002
Krasnodar, Russian Federation, 350040
United Kingdom
Maidstone, Kent, United Kingdom, ME16 9QQ
Bebington, Merseyside, United Kingdom, CH63 4JY
Birmingham, West Midlands, United Kingdom, B15 2TT
London, United Kingdom, W12 0HS
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00108953    
Other Study ID Numbers: 11546
2004-001770-40 ( EudraCT Number )
First Posted: April 22, 2005    Key Record Dates
Results First Posted: June 11, 2009
Last Update Posted: October 31, 2014
Last Verified: October 2014
Keywords provided by Bayer:
Cancer
Liver Cancer
Hepatocellular carcinoma
HCC
Additional relevant MeSH terms:
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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
Sorafenib
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors