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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer

Intervention: thalidomide (Drug); doxorubicin hydrochloride (Drug); laboratory biomarker analysis (Other)

Phase: Phase 2

Status: Completed

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
Alec Goldenberg, Principal Investigator, Affiliation: New York University Langone Medical Center

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.

Clinical Details

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

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

Primary outcome: Survival

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

New York University Langone Medical Center, New York, New York 10016, United States
Additional Information

Starting date: May 2000
Last updated: April 14, 2015

Page last updated: August 23, 2015

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