Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
Completed · Phase 2
Conditions studied: Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer
In brief
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.
Key facts
- Study ID
- NCT00006016
- Run by
- National Cancer Institute (NCI)
- People needed
- 75
- Starts
- 2000-05-01
- Expected to finish
- 2005-04-01
- Last updated by the study team
- 2015-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- New York University Langone Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.