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The CapSul Trial: A Phase II Study of Sunitinib and Capecitabine for the Treatment of Unresectable or Metastatic Hepatocellular Carcinoma (HCC)


Phase 2
19 Years
N/A
Not Enrolling
Both
Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer

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Trial Information

The CapSul Trial: A Phase II Study of Sunitinib and Capecitabine for the Treatment of Unresectable or Metastatic Hepatocellular Carcinoma (HCC)


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.


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:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median progression-free survival

Outcome Description:

Analyzed using the Kaplan-Meier method.

Outcome Time Frame:

From the start of treatment to time of progression or death from any cause, assessed up to 18 weeks

Safety Issue:

No

Principal Investigator

Samuel Whiting

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Institutional Review Board

Study ID:

6553

NCT ID:

NCT00787787

Start Date:

September 2008

Completion Date:

June 2010

Related Keywords:

  • Adult Primary Hepatocellular Carcinoma
  • Advanced Adult Primary Liver Cancer
  • Localized Unresectable Adult Primary Liver Cancer
  • Recurrent Adult Primary Liver Cancer
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109