AzTrials
AzTrials

Carcinoma, HepatocellularPhase 2NCT00108953

A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin in people with Carcinoma, Hepatocellular, run by Bayer at 28 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
28 sitesin 6 countries
Study dates
Apr 2005to Apr 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

28 sites in 6 countries.

28 sites in 6 countries

United States15 sites

  • Study site

    Beverly Hills, California, 90211-1850

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Hackensack, New Jersey, 07601

  • Study site

    Lafayette, Louisiana, 70506

  • Study site

    Miami, Florida, 33136

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New York, New York, 10065

  • Study site

    Orange, California, 92668-3298

  • Study site

    Palo Alto, California, 94304-1207

  • Study site

    Rochester, New York, 14642

  • Study site

    San Francisco, California, 94115

  • Study site

    San Francisco, California, 94121

  • Study site

    Seattle, Washington, 98101

  • Study site

    Sylmar, California, 91342

Other trials in United States

United Kingdom5 sites

  • Study site

    Bebington, Merseyside, CH63 4JY

  • Study site

    Birmingham, West Midlands, B15 2TT

  • Study site

    London, London, W12 0HS

  • Study site

    Maidstone, Kent, ME16 9QQ

  • Study site

    Manchester, Manchester, M20 4BX

Other trials in United Kingdom

Argentina3 sites

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1264AAA

  • Study site

    Buenos Aires

  • Study site

    Neuquén, Neuquén Province, Q8300HDH

Other trials in Argentina

Russia3 sites

  • Study site

    Kazan', 420111

  • Study site

    Kirov, 610002

  • Study site

    Krasnodar, 350040

Other trials in Russia

Canada1 site

  • Study site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Hong Kong1 site

  • Study site

    Hong Kong, Hong Kong

Other trials in Hong Kong

About this study

Official title: A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in 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).

Read the 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).

Being tested
Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin, Doxorubicin/Placebo
Keywords
Cancer, Liver Cancer, Hepatocellular carcinoma, HCC
Medical subject headings
Carcinoma, Hepatocellular, Neoplasms, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sorafenib (Nexavar, BAY43-9006) plus DoxorubicinDrug

    Multi kinase inhibitor plus Chemotherapy

  • Doxorubicin/PlaceboDrug

    Chemotherapy plus Placebo

Study groups in NCT00108953
Study groupRoleWhat they receive
Sorafenib + DoxorubicinExperimental"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)
Receives: Drug: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin
Placebo + DoxorubicinActive comparator"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)
Receives: Drug: Doxorubicin/Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Progression (TTP)

    TTP was defined as the time from randomization to radiological disease progression by independent assessment.

    Measured: from date of randomization of the first patient until 3 years later

Secondary outcomes (7)

  1. Overall Survival

    The time from date of randomization to date of death

    Measured: from date of randomization of the first patient until 3 years later

  2. Progression Free Survival (PFS)

    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

    Measured: from date of randomization of the first patient until 3 years later

  3. Percentage of Participants in Each Category of Best Tumor Response

    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.

    Measured: achieved during treatment or within 30 days after termination of active therapy

  4. Time to Symptomatic Progression (TTSP)

    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

    Measured: from date of randomization of the first patient until 3 years later

  5. Duration of Response

    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

    Measured: from date of randomization of the first patient until 3 years later

  6. Time to Response (TTR)

    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

    Measured: from date of randomization until 3 years later at end of study

  7. Percentage of Participants for Whom Disease Control Was Achieved

    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)

    Measured: from date of randomization to end of treatment plus 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00108953
Sponsor's protocol ID
11546
Other IDs
2004-001770-40, 2004
Status last verified
Oct 2014
First submitted
21 Apr 2005
Last updated
31 Oct 2014
Data monitoring committee
No

Publications

  • Abou-Alfa GK, Schwartz L, Ricci S, Amadori D, Santoro A, Figer A, De Greve J, Douillard JY, Lathia C, Schwartz B, Taylor I, Moscovici M, Saltz LB. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2006 Sep 10;24(26):4293-300. doi: 10.1200/JCO.2005.01.3441. Epub 2006 Aug 14.

    PubMed 16908937

  • Abou-Alfa GK, Johnson P, Knox JJ, Capanu M, Davidenko I, Lacava J, Leung T, Gansukh B, Saltz LB. Doxorubicin plus sorafenib vs doxorubicin alone in patients with advanced hepatocellular carcinoma: a randomized trial. JAMA. 2010 Nov 17;304(19):2154-60. doi: 10.1001/jama.2010.1672.

    PubMed 21081728

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin in people with Carcinoma, Hepatocellular, run by Bayer at 28 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, United Kingdom, Argentina, Russia, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Progression (TTP) (time frame: from date of randomization of the first patient until 3 years later). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00108953, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in