A Phase II Study of Intra-arterial Chemotherapy With Cisplatin and Mitomycin-C in Patients With Hepatocellular Carcinoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/18/2018 |
| Start Date: | October 18, 2004 |
| End Date: | May 28, 2019 |
A Phase II Study of Intra-arterial Chemotherapy With Cisplatin and Mitomycin-C
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.
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.
Inclusion Criteria:
- Unresectable, histologically confirmed hepatocellular carcinoma with evident disease
limited to liver.
- Tissue from tumor must be available. This may be paraffin embedded tissue from
previous biopsy/resection or if it is not available, a repeat biopsy must be
performed. The requirement for biopsy may be waived if alpha-fetoprotein is greater
than 500 ng/mL and in the investigators opinion not explained by a concurrent hepatic
inflammatory process.
- Patients must agree to have a 20 cc blood sample drawn in addition to routine labs
with each cycle of chemotherapy.
- Patients must have measurable disease. If prior radiation therapy was administered,
measurable disease must be outside the radiation field.
- Patients must have a Zubrod performance status of 0-2.
- Patients must have a predicted life expectancy of at least 12 weeks.
- Patients must have a pre-treatment granulocyte count (i.e., segmented neutrophils +
bands) of greater than or equal to 1,500/mm3, a hemoglobin level of greater than or
equal to 9 gm/dl, and platelet count greater than or equal to 50,000/mm3. The
granulocyte requirement may be waived if in the investigator's opinion the lower count
reflects hypersplenism with adequate bone marrow reserves.
- Patients must have adequate renal function as documented by a calculated creatinine
clearance ≥ 60.
- Patients must have adequate hepatic function as documented by a serum bilirubin less
than or equal to 2x the institutional upper limit of normal, regardless of whether
patients have liver involvement secondary to tumor. Patients may not have ascites or
the ascites must be responsive to diuretics.
Exclusion Criteria:
- Patients who have received prior chemotherapy for unresectable disease
- Patients with any active or uncontrolled infection, including known HIV infection.
(Patients with active hepatitis B will be placed on lamivudine. Patients with active
hepatitis C will be eligible if liver tests qualify (5.1.9)
- Patients with psychiatric disorders that would interfere with consent or follow-up.
Pregnant or lactating women. Men and women of reproductive potential may not
participate unless they have agreed to use an effective contraceptive method.
- Patients with any other severe concurrent disease, which in the judgment of the
investigator, would make the patient inappropriate for entry into this study.
We found this trial at
1
site
1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
Click here to add this to my saved trials
