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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00787787
First received: November 7, 2008
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Drug: sunitinib malate
Drug: capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The CapSul Trial: A Phase II Study of Sunitinib and Capecitabine for the Treatment of Unresectable or Metastatic Hepatocellular Carcinoma (HCC)

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Median progression-free survival [ Time Frame: From the start of treatment to time of progression or death from any cause, assessed up to 18 weeks ] [ Designated as safety issue: No ]
    Analyzed using the Kaplan-Meier method.


Secondary Outcome Measures:
  • 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) [ Time Frame: From the start of the treatment until disease progression/recurrence, assessed every 3 months ] [ Designated as safety issue: No ]
  • Median overall survival [ Time Frame: From start of treatment until death from any cause, assessed up to 1 year ] [ Designated as safety issue: No ]
  • Categorical changes in ECOG performance status [ Time Frame: Baseline, day 1 of each course, and at the end of treatment ] [ Designated as safety issue: No ]
  • Anti-tumor response as assessed by serial AFP measurement [ Time Frame: Baseline, day 1 of each course, and at the end of treatment ] [ Designated as safety issue: No ]
  • Incidence of treatment-emergent adverse events [ Time Frame: Day 1 and day 30 after the last dose of study drug ] [ Designated as safety issue: Yes ]
  • Toxicity as assessed by changes in laboratory values, vital signs, and physical examination findings and rated by NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: At each clinic visit ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: September 2008
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Given PO
Other Names:
  • SU11248
  • sunitinib
  • Sutent
Drug: capecitabine
Given PO
Other Names:
  • CAPE
  • Ro 09-1978/000
  • Xeloda

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787787

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Samuel Whiting Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00787787     History of Changes
Other Study ID Numbers: 6553, NCI-2010-00605
Study First Received: November 7, 2008
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Carcinoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Capecitabine
Fluorouracil
Sunitinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014