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Sunitinib Malate and Capecitabine in Treating Patients With Unresectable or Metastatic Liver Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT00787787•University of Washington

View on ClinicalTrials.gov

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

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

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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)

Exclusion Criteria

•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
+17 more criteria

Locations (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Key Dates

Start Date

September 1, 2008

Primary Completion Date

April 1, 2010

Completion Date

June 1, 2010

Last Updated

June 1, 2017

Enrollment

ACTUAL participants

Conditions

Adult Primary Hepatocellular CarcinomaAdvanced Adult Primary Liver CancerLocalized Unresectable Adult Primary Liver CancerRecurrent Adult Primary Liver Cancer

Interventions

sunitinib malate

DRUG

capecitabine

DRUG

Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer

NCT01730937

Adult Primary Hepatocellular CarcinomaAdvanced Adult Primary Liver Cancer+1 more

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COMPLETEDNA

PET-CT in Determining the Radioembolization Dose Delivered to Patients With Liver Metastasis, Primary Liver Cancer, or Biliary Cancer

NCT02088775

Adult Primary Hepatocellular CarcinomaAdvanced Adult Primary Liver Cancer+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 1, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer

PET-CT in Determining the Radioembolization Dose Delivered to Patients With Liver Metastasis, Primary Liver Cancer, or Biliary Cancer

Sorafenib Tosylate Following a Liver Transplant in Treating Patients With Liver Cancer

CPI-613 in Treating Patients With Advanced or Metastatic Bile Duct Cancer That Cannot Be Removed By Surgery

Lapatinib in Treating Patients With Locally Advanced or Metastatic Biliary Tract or Liver Cancer That Cannot Be Removed By Surgery

Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer