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

NCT00787787 | Terminated Phase 2 Results

• 2 other identifiers: 6553NCI-2010-00605
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Conditions

Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Median Progression-free Survival

  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.

  From the start of treatment to time of progression or death from any cause, assessed up to 3 years

Secondary Outcomes (2)

• 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

Study Arms (1)

Treatment (sunitinib malate and capecitabine)

EXPERIMENTAL

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; Drug: capecitabine

Interventions

sunitinib malate DRUG

Given PO

Also known as: SU11248, sunitinib, Sutent

Treatment (sunitinib malate and capecitabine)

capecitabine DRUG

Given PO

Also known as: CAPE, Ro 09-1978/000, Xeloda

Treatment (sunitinib malate and capecitabine)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sunitinib; Capecitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Medical Director, Clinical Research Support
• Organization: Cancer Consortium

lmendels@fredhutch.org

206-667-5767

Study Officials

• Samuel Whiting

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2008
• First Posted: November 10, 2008
• Study Start: September 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 1, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-04

Locations

US (1)