At a glance
ClinicalIndex Comparison Record- ✓Unresectable hepatocellular carcinoma confirmed by histology with disease limited to liver
- ✓Measurable disease (outside radiation field if prior radiation given)
- ✓Tumor tissue available or biopsy performed (waivable if AFP >500 ng/mL)
- ✓Predicted life expectancy at least 12 weeks
- ✕Prior chemotherapy for unresectable disease
- ✕Active or uncontrolled infection, including HIV; active hepatitis B allowed if on lamivudine; hepatitis C allowed if liver tests qualify
- ✕Psychiatric disorder interfering with consent or follow-up; pregnant or lactating women
- ✕Severe concurrent disease making patient inappropriate for study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Intra-arterial Chemotherapy With Cisplatin and Mitomycin-C
In Brief
A Phase 2 clinical trial evaluating mitomycin-c, cisplatin for Hepatocellular Carcinoma and Liver Cancer. Completed, enrolled 76 participants across 1 site.
Detailed Summary
This study is for people with cancer of the liver that cannot be completely removed by surgery. This study involves giving the drugs mitomycin-C and cisplatin, into an artery in the liver. Mitomycin-C is a drug that has been approved by the FDA to treat cancer of the stomach and pancreas. Mitomycin-C is a drug that causes cancer cells to die and prevents them from reproducing. Cisplatin is also a drug that has been approved by the FDA. Cisplatin is approved to treat cancer of the testes, ovaries, lung, esophagus, bladder, head and neck. Cisplatin is a drug that prevents cancer cells from reproducing. The purpose of this study is to see how long it takes subjects' tumor(s) to grow after receiving the study drugs. Another purpose of this study is to look at the side effects of this study therapy and how long subjects survive after receiving it. An additional purpose of this study is to see how well we can predict subjects' response to the study therapy, based on blood and tumor tissue tests. These tests will measure the levels of genes (the cell's blueprint) in subjects' tumors and blood. These genes affect how people's bodies react to the cancer drugs.
Study Details
Timeline
Interventions
Intra-arterial cisplatin 60 mg/m2 and mitomycin-C 12 mg/m2 every 8 weeks