NCT00514228

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

June 26, 2012

Status Verified

June 1, 2012

Enrollment Period

1.1 years

First QC Date

August 8, 2007

Last Update Submit

June 25, 2012

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinomalocalized unresectable adult primary liver canceradvanced adult primary liver cancerrecurrent adult primary liver cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    at 12 weeks

Secondary Outcomes (8)

  • Objective response

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

  • Disease stabilization (DS)

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

  • Duration of DS

    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

  • Progression-free survival

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

  • Time to progression

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

  • +3 more secondary outcomes

Study Arms (1)

Continuous sunitinib treatment

EXPERIMENTAL
Drug: sunitinib malate

Interventions

sunitinib malateDRUG

* Starting dose: 37.5 mg 3 x 12.5 mg capsule * Reduced dose: 25 mg 2 x 12.5 mg capsule

Also known as: Sutent
Continuous sunitinib treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • 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
  • +30 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 20203173RESULT

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Dieter Koeberle, MD

    Cantonal Hospital of St. Gallen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2007

First Posted

August 9, 2007

Study Start

July 1, 2007

Primary Completion

August 1, 2008

Study Completion

February 1, 2009

Last Updated

June 26, 2012

Record last verified: 2012-06

Locations

CH(1)