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Liver CancerPhase 2NCT00949182

Sorafenib Tosylate Before and After Hepatic Arterial Chemoembolization With Doxorubicin Hydrochloride and Mitomycin C in Treating Patients With Localized Liver Cancer That Cannot Be Removed by Surgery

A Phase 2 study testing sorafenib tosylate, HACE : Doxorubicin Hydrochloride and Mitomycin C and laboratory biomarker analysis in people with Liver Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

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

Official record
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Trial summary

RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cancer
What is being tested?
sorafenib tosylate, HACE : Doxorubicin Hydrochloride and Mitomycin C and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Jul 2009to Jun 2013
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

  • Age > 18 years old
  • Confirmed HCC diagnosis by Biopsy or Radiologic parameters. Following NCCN guidelines for HACE, including subjects within the University of San Francisco transplant listing criteria.
  • ECOG Performance Status 0 or 1
  • Adequate bone marrow, liver and renal function as .assessed by the following:
  • Hemoglobin > 9.0 g/dl
  • Absolute neutrophil count (ANC) > 1,500/mm3
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  • Platelet count > 75,000/mm3
  • Total bilirubin < 2 mg/dl
  • ALT and AST < 2.5 times the ULN ( < 5 x ULN for patients with liver involvement)
  • Creatinine < 1.5 times mg/dl
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
  • Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
  • Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
  • INR < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
  • BCLC Stage B (Intermediate)
  • multinodular asymptomatic tumors
  • without vascular invasion
  • without extrahepatic spread
  • Child Pugh A through B7
  • Male or female patients > 18 years of age
  • Life expectancy of at least 12 weeks. Patients with unresectable, multinodular asymptomatic tumor (no vascular invasion or extrahepatic spread)
  • Patients with histologically or cytologically documented HCC. Documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable
  • Prior informed consent.
  • 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
  • The lesion has not been previously treated with local therapy (such as surgery, radiation therapy, RFA, PEI, or cryoablation)

Who cannot join

  • Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
  • Known brain metastasis or CNS disease. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
  • Known human immunodeficiency virus (HIV) infection
  • Active clinically serious infection > CTCAE Grade 2 except hepatitis B or C.
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  • Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
  • Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
  • Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
  • Serious non-healing wound, ulcer, or bone fracture.
  • Evidence or history of bleeding diathesis or coagulopathy
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
  • Use of St. John's Wort or rifampin (rifampicin).
  • Known or suspected allergy to sorafenib or any agent given in the course of this trial.
  • Any condition that impairs patient's ability to swallow whole pills.
  • Any malabsorption problem.
  • Use of any prior systemic chemotherapy or targeted agents.
  • Diffuse HCC or presence of vascular invasion (including segmental portal obstruction), extrahepatic spread
  • Advanced liver disease: unstable ascites or >Child-Pugh B7
  • Porto-systemic shunt
  • Any contraindication for an arterial procedure such as impaired clotting tests (platelet count < 50.000/mm3 or prothrombin activity < 50 percent), 1
  • Renal failure
  • Severe atheromatosis
  • Any contraindication for systemic chemotherapy administration (serum bilirubin > 5mg/dL, leukocyte count < 3.000 cells/mm3)
  • Any contraindication for sorafenib administration
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Pregnant or breast-feeding patients
  • Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated > 3 years prior to entry is permitted
  • Patients receiving therapy for Hepatitis A, B or C
  • Encephalopathy ≥ Grade 1.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rutgers University Hospital

    Newark, New Jersey, 07101

Other trials in United States

About this study

Official title: Micro and Macro Arteriolar Blockade of Hepatocellular Carcinoma (HCC): Treatment With Sorafenib Before and After Hepatic Arterial Embolization (HAE) Therapy for Liver Cancer.

RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking blood flow to the tumor. Giving sorafenib tosylate before and after chemoembolization may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving sorafenib tosylate before and after hepatic arterial chemoembolization with doxorubicin hydrochloride and mitomycin C works in treating patients with localized liver cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate the safety and tolerability of sorafenib tosylate therapy when administered before and after doxorubicin hydrochloride-based hepatic arterial chemoembolization (HACE) as assessed by NCI CTCAE v3.0 in patients with localized unresectable hepatocellular carcinoma.

Secondary

  • To determine if sorafenib tosylate decreases the number of HACE treatments required to achieve radiologic tumor kill.
  • To assess improvement in progression-free survival.
  • To assess changes in monthly AFP levels in patients with AFP-producing tumors.
  • To measure VEGF levels.

OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-14. Beginning ≥ 3 days later, patients undergo hepatic arterial chemoembolization (HACE)* with doxorubicin hydrochloride and mitomycin C. Beginning ≥ 3 days after the completion of HACE and/or once liver function returns to baseline, patients resume sorafenib tosylate twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients may undergo more than one HACE treatment.

Blood samples are collected periodically for further laboratory analysis.

Conditions
Liver Cancer
Being tested
sorafenib tosylate, HACE : Doxorubicin Hydrochloride and Mitomycin C, laboratory biomarker analysis
Keywords
localized unresectable adult primary liver cancer, adult primary hepatocellular carcinoma
Medical subject headings
Liver Neoplasms, Carcinoma, Hepatocellular

What participants receive

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

  • sorafenib tosylate, HACE : Doxorubicin Hydrochloride and Mitomycin CDrug

    Also called Doxorubicin brand name Adriamycin.

    After Sorafenib Tosylate has been administered the actual HACE procedure is performed using Doxorubicin Hydrochloride or Mitomycin C

  • laboratory biomarker analysisOther

Study groups in NCT00949182
Study groupRoleWhat they receive
Sorafenib Tosylate, Doxorubicin, Mytomicin CExperimentalMicro and Macro arteriolar blockade of hepatocellular carcinoma (HCC): Treatment with Sorafenib 400mg two weeks prior to embolization HACE which includes the use of agents such as Doxorubicin Hydrochloride and Mytomicin C, continuing same Sorafenib dose after the procedure (dose adjustment according to tolerance).
Receives: Drug: sorafenib tosylate, HACE : Doxorubicin Hydrochloride and Mitomycin C; Other: laboratory biomarker analysis

What is being measured

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

  1. Safety and tolerability as assessed by NCI CTCAE v3.0

    Measured: 06/2009 to 12/2010

Secondary outcomes (4)

  1. Number of hepatic arterial chemoembolization (HACE) treatments required to achieve objective complete response

    Measured: 06/2009 to 12/2010

  2. Progression-free survival and time to radiologic progression as assessed by CT scan

    Measured: 06/2009 to 12/2010

  3. Overall survival at 6, 12, and 24 months

    Measured: 06/2009 to 12/2011

  4. AFP and VEGF serum levels as assessed at baseline, prior to each HACE treatment, and then every 3 months thereafter

    Measured: 06/2009 to 12/2011

Timeline

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

  1. First posted30 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJun 2013
  4. Study completionJun 2013

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00949182
Sponsor's protocol ID
CDR0000649008
Other IDs
UMDNJ-20090859, BAYER-IST000477
Status last verified
Jan 2014
First submitted
29 Jul 2009
Last updated
14 Jan 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sorafenib tosylate, HACE : Doxorubicin Hydrochloride and Mitomycin C and laboratory biomarker analysis in people with Liver Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.

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 26 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: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety and tolerability as assessed by NCI CTCAE v3.0 (time frame: 06/2009 to 12/2010). 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 NCT00949182.

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 14 Jan 2014.

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