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

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Liposomal doxorubicin; Thalidomide

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