Sunitinib and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

NCT ID: NCT00524316

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2014-05-31

Brief Summary

RATIONALE: Sunitinib 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. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs, such as doxorubicin, near the tumor. Giving sunitinib together with chemoembolization may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving sunitinib together with chemoembolization works in treating patients with liver cancer that cannot be removed by surgery.

Detailed Description

OBJECTIVES:

Primary

• To determine the progression-free survival at 4 months of patients treated with this regimen.

Secondary

• To determine overall survival of these patients.
• To determine if dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can be used to measure decrease in tumor perfusion and vascular permeability as a result of treatment with sunitinib malate in combination with TACE, and if it can be useful in prognosis.
• To examine the safety and tolerability of this regimen.
• To determine if a change in circulating endothelial precursor cell number and total monocyte count on days 3, 8, 10, and 35 of therapy (as compared with levels at baseline) and decrease in soluble vascular endothelial growth factor receptor-2 in serum on days 8 (before TACE), 10, and 35 of therapy (as compared with baseline) correlate with improved response and survival.
• To determine the effect of this therapy on quality of life as measured by the FACT-HEP scale prior to each course of therapy.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily on days 1-7 and 15-35 in course 1 and on days 1-28 in all subsequent courses. Patients undergo hepatic artery chemoembolization with doxorubicin hydrochloride on day 8 of course 1 only. Treatment with sunitinib malate repeats every 6 weeks* in the absence of disease progression or unacceptable toxicity.

NOTE: *Course 1 is 7 weeks in duration; all subsequent courses are 6 weeks in duration.

Blood samples are collected at baseline and periodically during study to measure circulating endothelial precursor cell levels, total monocyte count, and soluble vascular endothelial growth factor receptor-2.

Quality of life is assessed by the FACT-HEP scale at baseline, prior to each course of treatment, and then at the completion of treatment.

After completion of study treatment, patients are followed every 6 months.

Conditions

Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sunitinib

oral sunitinib malate once daily on days 1-7 and 15-35 in course 1 and on days 1-28 in all subsequent courses

Group Type: EXPERIMENTAL

doxorubicin hydrochloride

Intervention Type: DRUG

Transarterial chemoembolization

sunitinib malate

Intervention Type: DRUG

Given Orally

laboratory biomarker analysis

Intervention Type: OTHER

Correlative Study

hepatic artery embolization

Intervention Type: PROCEDURE

Surgical procedure

quality-of-life assessment

Intervention Type: PROCEDURE

Correlative Study

Interventions

doxorubicin hydrochloride

Transarterial chemoembolization

Intervention Type: DRUG

sunitinib malate

Given Orally

Intervention Type: DRUG

laboratory biomarker analysis

Correlative Study

Intervention Type: OTHER

hepatic artery embolization

Surgical procedure

Intervention Type: PROCEDURE

quality-of-life assessment

Correlative Study

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• More than 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas or mitomycin C)
• More than 4 weeks since prior major surgery or open biopsy
• At least 1 week since prior fine needle biopsy
• No concurrent immunotherapy
• No concurrent radiotherapy
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent therapeutic doses of coumarin-derivative anticoagulants (e.g., warfarin)

• Doses of ≤ 1 mg/day are allowed for prophylaxis of thrombosis as long as INR ≤ 1.5
• Both full dose and prophylactic dose low molecular weight heparin allowed as long as PT INR ≤ 1.5
• No anticipated major surgery during and for 3 months after completion of study treatment
• No other concurrent investigational agents
• No other concurrent anticancer therapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renuka Iyer, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-I-82706

Identifier Type: -

Identifier Source: secondary_id

CDR0000563261

Identifier Type: -

Identifier Source: org_study_id