The CapSul Trial: A Phase II Study of Sunitinib and Capecitabine for the Treatment of Unresectable or Metastatic Hepatocellular Carcinoma (HCC)
Overview
- Phase
- Phase 2
- Intervention
- sunitinib malate
- Conditions
- Adult Primary Hepatocellular Carcinoma
- Sponsor
- University of Washington
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Median Progression-free Survival
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
Eligibility 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
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
Arms & Interventions
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.
Intervention: sunitinib malate
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.
Intervention: capecitabine
Outcomes
Primary Outcomes
Median Progression-free Survival
Time Frame: From the start of treatment to time of progression or death from any cause, assessed up to 3 years
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.
Secondary Outcomes
- Best Response by RECIST Criteria(From the start of the treatment until disease progression/recurrence, assessed every 3 months, up to 3 years)
- Median Overall Survival(From start of treatment until death from any cause, assessed up to 3 years)