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Liver CarcinomaPhase 2SoraDoxNCT01272557

Sorafenib Plus Doxorubicin Versus Sorafenib Alone for the Treatment of Advanced Hepatocellular Carcinoma: a Randomized Phase II Trial

A Phase 2 study testing Doxorubicin and Sorafenib in people with Liver Carcinoma, run by PD Dr. med. Matthias Dollinger at 6 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a prospective, randomized, open-label, multicenter phase IIB trial in order to determine time to progression of the combination therapy sorafenib plus doxorubicin against standard-of-care sorafenib in advanced HCC not amenable to non-systemic treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Carcinoma
What is being tested?
Doxorubicin and Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
6 sitesGermany
Study dates
Dec 2010to Dec 2014
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Non-resectable locally advanced or metastasized HCC
  • Subjects must have at least one tumor lesion that meets both of the following criteria:
  • the lesion can be accurately measured in at least one dimension according to RECIST 1.1
  • the lesion has not been previously treated with local therapy (such as surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation)
  • Subjects who have received local therapy (such as surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) are eligible, provided that they have a target lesion which has not been subjected to local therapy. Local therapy must be completed at least 4 weeks prior to the baseline scan.
  • Confirmation of disease by histology
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  • Liver function: Child Pugh stage A/B (5-7 points) only
  • Tumor stage: BCLC stage C (or better)
  • ECOG performance status 0-2
  • Life expectancy of at least 12 weeks
  • Age ≥ 18 years
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening and within 4 weeks before start of treatment:
  • Hemoglobin ≥ 9.0 g/dl
  • Absolute neutrophil count (ANC) ≥1.500/mm3
  • Platelet count ≥ 70.000/μl
  • Total bilirubin ≤ 3 mg/dl
  • ALT and AST ≤ 5 x upper limit of normal
  • Alkaline phosphatase < 4 x upper limit of normal
  • PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as warfarin, phenprocoumon or heparin will NOT be allowed to participate]
  • Serum creatinine ≤ 1.5 x upper limit of normal
  • Signed and dated informed consent before start of any study specific procedure

Who cannot join

  • Patients eligible for resection or transplantation
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study. However cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1) or any cancer curatively treated > 3 years prior to entry is permitted
  • Serious myocardial dysfunction: defined as absolute left ventricular ejection fraction (LVEF) < 50%, instable coronaropathy (MI more than 6 mo prior to study entry is allowed), cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
  • Inadequately controlled hepatic complications (varices, encephalopathy)
  • Untreated active Hepatitis B including HBs-Ag carriers; patients should be started on (prophylactic) anti-viral medication even without current viral replication
  • Concomitant therapy with interferon (e.g. Hepatitis B/C) during study phase
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  • Uncontrolled arterial hypertension with systolic blood pressure >160 mmHg or diastolic blood pressure > 90 mm Hg despite optimal treatment
  • Known history of HIV infection
  • Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
  • Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
  • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
  • History of organ allograft
  • Patients with evidence or history of bleeding diathesis
  • Thrombotic or embolic events within the last 6 months
  • Serious non-healing wound, fracture, or ulcer
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial for at least 6 months after last administration of doxorubicin and 2 months after the last administration of sorafenib.
  • Severe concomitant disease or psychiatric disorders
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Known severe hypersensitivity to sorafenib, doxorubicin or any of the excipients
  • Patients unable to swallow oral medications
  • Incompliance / contraindications against study medication
  • Excluded therapies and medications, previous and concomitant:
  • Previous systemic therapy for HCC
  • Anticancer chemotherapy or immunotherapy or targeted therapy (except study medication) during the study or within 4 weeks of study entry.
  • Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed). Major surgery within 4 weeks of start of study
  • Autologous bone marrow transplant or stem cell rescue within 4 months of study
  • Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
  • Patients receiving anticoagulation therapy or ASS >100 mg/d
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
  • Prior exposure to the study drug.
  • Any St. John's wort containing remedy

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Medizinische Klinik und Poliklinik, Heinrich-Heine-Universität

    Düsseldorf, 40225

  • Martin-Luther-University Halle-Wittenberg

    Halle, D-06099

  • Universitätsklinikum des Saarlande

    Homburg/Saar, 66421

  • Ortenau Klinikum Lahr-Ettenheim

    Lahr, 77933

  • Universitätsklinikum Leipzig

    Leipzig, 04013

  • Klinikum Ludwigsburg

    Ludwigsburg, 71640

Other trials in Germany

About this study

This study is a prospective, randomized, open-label, multicenter phase IIB trial in order to determine time to progression of the combination therapy sorafenib plus doxorubicin against standard-of-care sorafenib in advanced HCC not amenable to non-systemic treatment.

Conditions
Liver Carcinoma
Being tested
Doxorubicin, Sorafenib
Keywords
HCC
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • DoxorubicinDrug

    Doxorubicin 60 mg/m2 i.v. on day 1 every 21 days Sorafenib 400 mg bid (oral) from day 3-19 every 21 days. Maximum accumulative dose of doxorubicin: 360 mg/m2 (thereafter sorafenib monotherapy continuously until progression or unacceptable toxicity).

  • SorafenibDrug

    Sorafenib 400 mg bid (oral) continuously

Study groups in NCT01272557
Study groupRoleWhat they receive
Sorafenib 400 mg bid (oral) continuouslyActive comparatorSorafenib 400 mg bid (oral) continuously until progression or unacceptable toxicity).
Receives: Drug: Sorafenib
q22d: Doxorubicin 60 mg/m2 i.v d1, Sorafenib 400 mg bid d3-19ExperimentalDuring trial therapy period in Arm-A treated patients will receive doxorubicin infusion with 60mg/m² on day 1 every 21 days for maximum of 18 weeks (or 6 cycles) until a maximal dose of 360mg/m² are reached. Sorafenib 400mg bid (oral) will be administered from day 3-19 every 21 days during the trial therapy period
Receives: Drug: Doxorubicin

What is being measured

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

  1. Time to progression (TTP) according to RECIST 1.1 criteria

    Measured: The follow-up period ends 12 months after enrolment of the last patient (end of study visit of the last patient unless he died earlier

Secondary outcomes (1)

  1. • Assessment of overall survival (OS) of disease control rate (CR, PR, SD) to RECIST 1.1 criteria and to EASL criteria • Assessment of safety and quality of life (FACT-Hep) and potential of biomarkers to predict the tumor response

    Measured: The follow-up period ends 12 months after enrolment of the last patient (end of study visit of the last patient unless he died earlier).

Timeline

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

  1. First posted7 Jan 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionSep 2014 (estimated)
  4. Study completionDec 2014 (estimated)

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
None (open label)
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01272557
Sponsor's protocol ID
SoraDox
Acronym
SoraDox
Status last verified
Mar 2014
First submitted
6 Jan 2011
Last updated
1 Apr 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Doxorubicin and Sorafenib in people with Liver Carcinoma, run by PD Dr. med. Matthias Dollinger at 6 sites in Germany.

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 21 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. 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?

Results are not available in the source record.

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) according to RECIST 1.1 criteria (time frame: The follow-up period ends 12 months after enrolment of the last patient (end of study visit of the last patient unless he died earlier). 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 NCT01272557.

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 1 Apr 2014.

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