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Completed

NCT Number: NCT00108953

A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma

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).

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin

Drug

Multi kinase inhibitor plus Chemotherapy

Doxorubicin/Placebo

Drug

Chemotherapy plus Placebo

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Apr 22, 2005
Registry last updated
Oct 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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