Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery

Advanced Adult Primary Liver Cancer Clinical Trial

Official title:

An Evaluation of Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006016
• Other study ID #: NCI-2012-02352
• Secondary ID: NCI-2012-02352NC
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2000
• Last updated: April 14, 2015
• Start date: May 2000
• Est. completion date: April 2005

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This phase II trial is studying the effectiveness of combining thalidomide and chemoembolization in treating patients who have liver cancer that cannot be removed by surgery. Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Combining thalidomide with chemoembolization may kill more tumor cells.

Description:

OBJECTIVES:

I. Determine the feasibility and potential activity of thalidomide in patients with unresectable hepatocellular carcinoma who are undergoing chemoembolization to predominant tumor masses.

II. Determine the toxicity of this regimen of these patients. III. Determine the overall survival of patients treated with this regimen. IV. Determine the serum levels of vascular endothelial growth factor, basic fibroblast growth factor, and tumor necrosis factor alpha in patients treated with this regimen.

OUTLINE:

Patients receive oral thalidomide daily beginning 4 weeks before the first planned chemoembolization procedure. Thalidomide administration is stopped 24 hours before each chemoembolization procedure, and then restarted at 24 hours after completion of each procedure OR when blood counts and levels of bilirubin and transaminases recover, whichever occurs later. Thalidomide treatment continues in the absence of disease progression or unacceptable toxicity.

Patients undergo placement of a visceral arterial catheter. Patients receive doxorubicin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only under angiographic guidance. Immediately after delivery of the chemoemulsion, patients undergo particulate embolization. The opposite lobe, if involved, is treated within 3-5 weeks of treatment of the initial lobe. Patients are reevaluated for repeat chemoembolization within 8-12 weeks of the last chemoembolization. For eligible patients, each lobe is treated separately a second time, in the same sequence, in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 18 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven hepatocellular carcinoma

• Ineligible for potentially curative surgical resection

• Must be a candidate for palliative chemoembolization

• MRI must show one or more discrete tumor nodules that can be targeted by angiography for chemoembolization

• No diffusely infiltrating tumor

• Lesions under consideration for chemoembolization must demonstrate substantial hypervascularity

• Performance status - ECOG 0-2

• Absolute neutrophil count at least 1,200/mm^3

• Hemoglobin at least 8.0 g/dL

• Platelet count at least 50,000/mm^3

• SGOT and SGPT no greater than 5 times normal

• Bilirubin less than 3 mg/dL

• Creatinine no greater than 1.5 mg/dL

• No other medical condition that would preclude study participation

• No other malignancy within the past 5 years except curatively resected basal cell skin cancer or carcinoma in situ of the cervix

• Not pregnant or nursing

• Negative pregnancy test

• Regardless of fertility status:

• All female patients (unless they have undergone a hysterectomy or have been amenorrheic or postmenopausal for at least 2 years) must use at least 1 highly active method of contraception AND 1 additional effective method of contraception at least 4 weeks before, during, and for at least 4 weeks after study participation

• All male patients (even if they have undergone a successful vasectomy) must use effective barrier contraception during and for at least 4 weeks after study participation

• Prior interferon for hepatitis allowed

• No prior biologic therapy for hepatocellular carcinoma (HCC)

• No prior chemotherapy for hepatocellular carcinoma (HCC)

• No concurrent barbiturates or alcohol

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Primary Hepatocellular Carcinoma
• Advanced Adult Primary Liver Cancer
• Carcinoma, Hepatocellular
• Liver Neoplasms
• Localized Unresectable Adult Primary Liver Cancer

Intervention

Drug:
• thalidomide
Given orally
• doxorubicin hydrochloride
Given transarterially (chemoembolization)

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	New York University Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	The survival distribution will be estimated using the Kaplan-Meier method, with corresponding 95% confidence intervals.	Up to 18 months	No