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TerminatedNCT00787787Updated Jun 1, 2017Results posted

Sunitinib Malate and Capecitabine in Treating Patients With Unresectable or Metastatic Liver Cancer

A Phase 2 interventional study of sunitinib malate and capecitabine in Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer and Localized Unresectable Adult Primary Liver Cancer, sponsored by University of Washington. Terminated at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-06-01.

Sponsored by University of Washington · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

This phase II trial studies how well giving sunitinib malate together with capecitabine works in treating patients with unresectable or metastatic liver cancer. Sunitinib malate 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 capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib malate together with capecitabine may kill more tumor cells

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine the progression-free survival of patients with unresectable or metastatic hepatocellular carcinoma (HCC) treated with sunitinib and capecitabine.

SECONDARY OBJECTIVES:

I. To determine the overall survival, response rate by Response Evaluation Criteria in Solid Tumors (RESIST) criteria, alpha fetoprotein (AFP) response, survival at one year, and safety and tolerability.

OUTLINE:

Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-21 and capecitabine PO twice daily (BID) on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 2 years.

02

Conditions studied

  • Adult Primary Hepatocellular Carcinoma
  • Advanced Adult Primary Liver Cancer
  • Localized Unresectable Adult Primary Liver Cancer
  • Recurrent Adult Primary Liver Cancer
03

In context

Carcinoma, Hepatocellular

3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's enrollment of 41 is below the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histologically confirmed diagnosis of hepatocellular carcinoma (HCC) OR meets radiographic criteria for diagnosis of HCC without biopsy
  • Liver mass at least 1 cm up to 2 cm in size: classic enhancement on 2 approved imaging modalities
  • Liver mass > 2 cm in size: classic enhancement on 1 approved imaging modality
  • At least one site of bidimensional measurable disease with the longest axis >= 20mm by conventional computed tomography (CT) scan or >= 10mm by spiral CT scan or >= 10mm by magnetic resonance imaging (MRI)
  • Not eligible for curative intent surgery and not eligible for, or not willing to undergo, orthotopic liver transplantation
  • Patient has received =\< 1 prior systemic therapy
  • Patient has completed treatment with surgery at least 4 weeks prior to study drug administration
  • Patient has completed other cancer directed treatments including systemic chemotherapy, transarterial chemotherapy, transarterial chemoembolization or bland embolization, targeted therapy, radiotherapy, or treatment with other investigational anti-cancer agents at least 4 weeks prior to study drug administration AND has radiographic evidence of disease progression following these treatments
  • Life expectancy of greater than 12 weeks
  • Child-Pugh class A or B
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky > 60%)
  • Platelet count >= 75,000/mm\^3
  • Absolute neutrophil count >= 1,500/mm\^3
  • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =\< 5 times upper limit of normal (ULN)
  • Total bilirubin =\< 3 times ULN
  • Calculated or measured creatinine clearance >= 40 mL/min
  • Prothrombin time =\< 1.5 international normalized ratio (INR)
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document and comply with scheduled visits, treatment plan, laboratory testing, and other trial procedures

Exclusion criteria

Exclusion Criteria:

  • History of another cancer within the last 5 years with the exception of localized basal or squamous cell carcinoma of the skin or stage 1A cervical cancer
  • Known brain metastases, spinal cord compression, or evidence of symptomatic brain or leptomeningeal carcinomatosis on screening CT or MRI scan
  • National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Grade 2 variceal bleed within 6 weeks of registration or Grade 3 other bleed within 4 weeks of registration
  • Any of the following within the 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
  • Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 Grade 2
  • Prolonged QTc interval on baseline electrocardiograph (EKG)
  • Uncontrolled Hypertension (> 150/100 mm Hg despite optimal medical therapy)
  • Severe hepatic impairment, defined as Childs-Pugh Class C
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
  • Concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. quality of life (QOL), are allowed
  • Pregnancy or breastfeeding; female subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy; all female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment; male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy; the definition of effective contraception will be based on the judgment of the principal investigator or a designated associate
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib or capecitabine
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Treatment (sunitinib malate and capecitabine)

    Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.

    Drug: sunitinib malate · Drug: capecitabine

Interventions

06

What researchers measure

Primary outcomes

  1. Median Progression-free Survival

    Analyzed using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease (PD) indicates at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Time frame: From the start of treatment to time of progression or death from any cause, assessed up to 3 years

Secondary outcomes

  1. Best Response by RECIST Criteria

    Incidence rate of best clinical response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], or progressive disease\[PD\]) as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR indicates disappearance of all target lesions. PR indicates at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease indicates at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) indicates neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

    Time frame: From the start of the treatment until disease progression/recurrence, assessed every 3 months, up to 3 years

  2. Median Overall Survival

    Survival estimated by Kaplan-Meier method

    Time frame: From start of treatment until death from any cause, assessed up to 3 years

07

Results

Posted Jun 1, 2017

Participant flow

Due to the lack of apparent benefit, the study was closed to further enrollment after the 7th patient was enrolled.

Participant flow — Overall Study
MilestoneTreatment (Sunitinib Malate and Capecitabine)
Started7
Completed0
Not completed7
Withdrew: Lack of efficacy4
Withdrew: Adverse event3

Outcome measures

PrimaryMedian Progression-free Survival

Analyzed using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease (PD) indicates at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Time frame:
From the start of treatment to time of progression or death from any cause, assessed up to 3 years
Reported as:
Median · days
Median Progression-free Survival
daysTreatment (Sunitinib Malate and Capecitabine)
Median Progression-free Survival203 (13 to 292)
SecondaryBest Response by RECIST Criteria

Incidence rate of best clinical response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], or progressive disease\[PD\]) as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR indicates disappearance of all target lesions. PR indicates at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease indicates at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) indicates neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Time frame:
From the start of the treatment until disease progression/recurrence, assessed every 3 months, up to 3 years
Reported as:
Count of participants · Participants
Best Response by RECIST Criteria
ParticipantsTreatment (Sunitinib Malate and Capecitabine)
Complete Response0
Partial Response0
Stable Disease4
SecondaryMedian Overall Survival

Survival estimated by Kaplan-Meier method

Time frame:
From start of treatment until death from any cause, assessed up to 3 years
Reported as:
Median · days
Median Overall Survival
daysTreatment (Sunitinib Malate and Capecitabine)
Median Overall Survival282 (157 to 400)

Adverse events

Collected over Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Sunitinib Malate and Capecitabine)7/7 (100%)2/7 (28.6%)7/7 (100%)
Most frequent serious events
Most frequent serious events
EventTreatment (Sunitinib Malate and Capecitabine)
Extrapyramidal myelinosisNervous system disorders1/7
Pleural effusionRespiratory, thoracic and mediastinal disorders1/7
Most frequent other events
Showing 10 of 13
Most frequent other events
EventTreatment (Sunitinib Malate and Capecitabine)
Hand-foot SyndromeSkin and subcutaneous tissue disorders5/7
ThrombocytopeniaBlood and lymphatic system disorders3/7
NeutropeniaBlood and lymphatic system disorders3/7
NauseaGastrointestinal disorders2/7
MucositisGastrointestinal disorders2/7
HeadacheNervous system disorders1/7
VomitingGastrointestinal disorders1/7
AnemiaBlood and lymphatic system disorders1/7
HypertensionVascular disorders1/7
Oral Herpes Simplex infectionInfections and infestations1/7

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment (Sunitinib Malate and Capecitabine)
Median57 (28 to 66)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Sunitinib Malate and Capecitabine)
Female0
Male7
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (Sunitinib Malate and Capecitabine)
Hispanic or Latino0
Not Hispanic or Latino7
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Sunitinib Malate and Capecitabine)
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American0
White5
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Treatment (Sunitinib Malate and Capecitabine)
United States7
08

Study locations

1 site
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2008, a primary completion of Apr 2010 and a completion of Jun 2010. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2017, 7 years 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2008
First posted
Nov 10, 2008
Start
Sep 2008
Primary completionActual
Apr 2010
CompletionActual
Jun 2010
Results first posted
Jun 1, 2017
Last update
Jun 1, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00787787
Responsible party
Sponsor
First posted
Nov 10, 2008
Start date
Sep 2008
Primary completion
Apr 2010
Completion
Jun 2010
Results posted
Jun 1, 2017
Last update
Jun 1, 2017

Study contacts

Samuel Whiting
principal investigator · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Sunitinib · Capecitabine

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