Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI NYU-9937 NCI-99, 99, NCT00006016

Objectives

1. Determine the feasibility and potential activity of thalidomide in patients with unresectable hepatocellular carcinoma who are undergoing chemoembolization to predominant tumor masses.
2. Determine the toxicity of this regimen of these patients.
3. Determine the overall survival of patients treated with this regimen.
4. Determine the serum levels of vascular endothelial growth factor, basic fibroblast growth factor, and tumor necrosis factor alpha in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

• Prior interferon for hepatitis allowed
• No prior biologic therapy for hepatocellular carcinoma (HCC)

Chemotherapy:

• No prior chemotherapy for hepatocellular carcinoma (HCC)

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

Other:

• No concurrent barbiturates or alcohol

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,200/mm³
• Hemoglobin at least 8.0 g/dL
• Platelet count at least 50,000/mm³

Hepatic:

• SGOT and SGPT no greater than 5 times normal
• Bilirubin less than 3 mg/dL

Renal:

• Creatinine no greater than 1.5 mg/dL

Other:

• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

NYU Cancer Institute at New York University Medical Center

Alec Goldenberg, MD, Protocol chair		Ph: 212-689-6791 Email: alecgold@email.com

Registry Information
Official Title		An Evaluation of Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer
Trial Start Date		2000-09-21
Registered in ClinicalTrials.gov		NCT00006016
Date Submitted to PDQ		2000-05-26
Information Last Verified		2004-12-29
NCI Grant/Contract Number		P30-CA16087, U01-CA76642

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