A Phase II Study of Intra-arterial Chemotherapy With Cisplatin and Mitomycin-C in Patients With Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT00183885|
Recruitment Status : Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : May 16, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Liver Cancer||Drug: mitomycin-c, cisplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Intra-arterial Chemotherapy With Cisplatin and Mitomycin-C|
|Actual Study Start Date :||October 18, 2004|
|Actual Primary Completion Date :||May 28, 2013|
|Estimated Study Completion Date :||May 28, 2019|
Experimental: Cisplatin + Mitomycin-C
CDDP 60mg/m2 + Mitomycin-C 12mg/m2
Drug: mitomycin-c, cisplatin
Intra-arterial cisplatin 60 mg/m2 and mitomycin-C 12 mg/m2 every 8 weeks
- Tumor Response [ Time Frame: Up to 2 years ]Tumor response will be assessed according to RECIST criteria.
- Number of participants with grade 3 or higher toxicity [ Time Frame: Up to 1 year ]Toxicity will be assessed according to CTCAE version 3.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183885
|United States, California|
|U.S.C. / Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Syma Iqbal, M.D.||U.S.C. / Norris Cancer Center|