Sunitinib Malate and Capecitabine in Treating Patients With Unresectable or Metastatic Liver Cancer
Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Drug: sunitinib malate
|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)|
- 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.
- 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 ]
|Study Start Date:||September 2008|
|Study Completion Date:||June 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
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
Other Names:Drug: capecitabine
I. To determine the progression-free survival of patients with unresectable or metastatic hepatocellular carcinoma (HCC) treated with sunitinib and capecitabine.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787787
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Samuel Whiting||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|