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Liver CancerPhase 2NCT00514228

Sunitinib in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

A Phase 2 study testing sunitinib malate in people with Liver Cancer, run by Swiss Cancer Institute at 1 site in Switzerland.

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: Sunitinib 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. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with liver cancer that cannot be removed by surgery. 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?
sunitinib malate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSwitzerland
Study dates
Jul 2007to Feb 2009
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

  • Histologically, cytologically, or radiologically confirmed hepatocellular carcinoma (HCC) meeting 1 of the following criteria:
  • Localized, surgically unresectable disease
  • Candidates for radical surgery for locally advanced disease are excluded
  • Metastatic disease
  • Measurable disease, defined as ≥ 1 lesion, outside of pretreated areas, that can be measured in ≥ 1 dimension as ≥ 10 mm by spiral or multi-slice CT scan or MRI
  • Child-Pugh class A or mildly decompensated Child-Pugh class B liver dysfunction
Show all 21Show fewer
  • WHO performance status 0-1
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • ALT ≤ 7 times ULN
  • Albumin ≥ 2.5 g/dL
  • Creatinine clearance ≥ 40 mL/min
  • Quick test ≥ 50% (adequate coagulation)
  • Urine dipstick for proteinuria < 2+ OR ≤ 1 g of protein in 24-hour urine collection
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study therapy
  • At least 4 weeks since prior surgery or liver-directed therapy (e.g., transarterial embolization/chemoembolization [limited to 5 treatments], radiofrequency ablation, cryoablation, radiotherapy, or percutaneous ethanol injection)
  • Previously treated lesions must remain separate from those to be measured in the present study
  • Low-dose anticoagulants for maintenance of patency of central venous access or prevention of deep vein thrombosis allowed

Who cannot join

  • Clinical ascites of any grade
  • Clinical symptoms or history of CNS metastases or leptomeningeal disease
  • Known fibrolamellar HCC or mixed cholangiocarcinoma and HCC
  • PATIENT CHARACTERISTICS:
  • Pregnant or nursing
  • Encephalopathy
Show all 30Show fewer
  • Malignancy within the past 5 years except for adequately treated cervical carcinoma in situ or localized nonmelanoma skin cancer
  • Hemorrhagic or thrombotic cerebrovascular event in the past 12 months
  • Documented variceal hemorrhage within the past 3 months
  • History or presence of clinically significant acute or unstable cardiovascular, cerebrovascular, renal, gastrointestinal, pulmonary, immunological (except for the presence of hepatitis B virus, hepatitis C virus, or cirrhosis), endocrine, or central nervous system disorders
  • Known HIV infection
  • Active infection requiring IV antibiotics
  • Arterial hypertension ≥ 150/100 mm Hg, despite therapy
  • Ongoing cardiac dysrhythmias ≥ grade 2
  • Atrial fibrillation of any grade
  • Prolongation of QTc > 500 msec in screening ECG or history of familial long QT syndrome
  • Inability to take oral medications
  • Psychiatric disorder precluding understanding of information of study-related topics, giving informed consent, or interfering with compliance for oral drug intake
  • PRIOR CONCURRENT THERAPY:
  • Prior systemic anticancer treatment for hepatocellular carcinoma
  • Prior organ transplantation
  • Treatment in a clinical study within the past 30 days
  • Concurrent full-dose anticoagulant or requirement for anticoagulant therapy
  • Concurrent experimental drugs or other anticancer therapy
  • Concurrent use or anticipated need for CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, erythromycin, clarithromycin, and protease inhibitors)
  • Concurrent CYP3A4 inducers (e.g., carbamazepine, continuous treatment with dexamethasone [> 2 mg/day for > 7 days], phenobarbital, phenytoin, rifampicin, and St John's wort)
  • Concurrent antacids allowed provided they are administered > 1 hour before or > 1 hour after study drug
  • Concurrent elective major surgery
  • Concurrent radiotherapy
  • Concurrent analgesic radiotherapy of nontarget lesions allowed

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

Other trials in Switzerland

About this study

Official title: Continuous Sunitinib Treatment in Patients With Unresectable Hepatocellular Carcinoma A Multicenter Phase II Trial

RATIONALE: Sunitinib 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.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with liver cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Demonstrate the antitumor activity of continuous sunitinib malate treatment in patients with unresectable hepatocellular carcinoma.

Secondary

  • Evaluate the safety of sunitinib malate treatment.
  • Measure serum cobalamin (i.e., vitamin B12) level during sunitinib malate treatment in order to investigate the relationship between sunitinib malate treatment and cobalamin deficiency.
  • Control the cobalamin deficiency by cobalamin replacement.
  • Investigate whether changes in tumor density could be used as a criterion for tumor response in future trials.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection on day 1 of each course to assess serum cobalamin levels and correlation with sunitinib malate treatment. Patients are also assessed for changes in tumor density and correlation with response. Baseline CT scans are compared with scans performed at 6 and 12 weeks to evaluate changes in CT-scan density due to tumor necrosis and response.

After completion of study therapy, patients are followed at least every 3 months for up to 3 years.

Conditions
Liver Cancer
Being tested
sunitinib malate
Keywords
adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer
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.

  • sunitinib malateDrug

    Also called Sutent

    • Starting dose: 37.5 mg 3 x 12.5 mg capsule
    • Reduced dose: 25 mg 2 x 12.5 mg capsule
Study groups in NCT00514228
Study groupRoleWhat they receive
Continuous sunitinib treatmentExperimentalNot described
Receives: Drug: sunitinib malate

What is being measured

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

  1. Progression-free survival

    Measured: at 12 weeks

Secondary outcomes (8)

  1. Objective response

    Measured: Objective response (CR+PR) to treatment will be determined. CR or PR is to be confirmed after a minimum of 4 weeks

  2. Disease stabilization (DS)

    Measured: Disease stabilization (CR, PR or SD) under sunitinib treatment will be determined

  3. Duration of DS

    Measured: Duration of DS (CR, PR or SD) will be calculated from the time that measurement criteria are met for the first time until documented tumor progression

  4. Progression-free survival

    Measured: PFS will be calculated from registration until documented tumor progression or death, whichever occurs first.

  5. Time to progression

    Measured: TTP will be calculated from registration until documented tumor progression or death due to tumor.

  6. Overall survival

    Measured: OS will be calculated from registration until death

  7. Adverse events as assessed by NCI CTCAE v3.0

    Measured: All AEs will be assessed according to NCI CTCAE v3.0.

  8. Serum alpha fetoprotein level

    Measured: Serum AFP levels will be measured during the therapy, if AFP is ≥ 1.5 x ULN at baseline.

Timeline

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

  1. First posted9 Aug 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionAug 2008
  4. Study completionFeb 2009

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
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00514228
Sponsor's protocol ID
SAKK 77/06
Other IDs
SWS-SAKK-77/06, EU-20750, EUDRACT-2007-003977-22, CDR0000560441
Status last verified
Jun 2012
First submitted
8 Aug 2007
Last updated
26 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • Koeberle D, Montemurro M, Samaras P, Majno P, Simcock M, Limacher A, Lerch S, Kovacs K, Inauen R, Hess V, Saletti P, Borner M, Roth A, Bodoky G. Continuous Sunitinib treatment in patients with advanced hepatocellular carcinoma: a Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) multicenter phase II trial (SAKK 77/06). Oncologist. 2010;15(3):285-92. doi: 10.1634/theoncologist.2009-0316. Epub 2010 Mar 4.

    PubMed 20203173

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sunitinib malate in people with Liver Cancer, run by Swiss Cancer Institute at 1 site in Switzerland.

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 30 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 26 Jun 2012. 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 Switzerland. 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?

Progression-free survival (time frame: at 12 weeks). 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 NCT00514228, which also lists 1 linked publication.

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 26 Jun 2012.

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