Hepatocellular CarcinomaPhase 2NCT00183885
A Phase II Study of Intra-arterial Chemotherapy With Cisplatin and Mitomycin-C in Patients With Hepatocellular Carcinoma
A Phase 2 study testing mitomycin-c, cisplatin in people with Hepatocellular Carcinoma and Liver Cancer, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cancer
- What is being tested?
- mitomycin-c, cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2004to 6 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S.C. / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Being tested
- mitomycin-c, cisplatin
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitomycin-c, cisplatinDrug
Intra-arterial cisplatin 60 mg/m2 and mitomycin-C 12 mg/m2 every 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin + Mitomycin-C | Experimental | CDDP 60mg/m2 + Mitomycin-C 12mg/m2 Receives: Drug: mitomycin-c, cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response
A modified Response Evaluation Criteria In Solid Tumors (RECIST) will be used. The modification to RECIST is that although all lesions will be followed, only the treated lesions will be included in the assessment of response. Additionally, all lesions will be evaluated according to the following criteria: Presence of arterial enhancement: Yes or No. Complete Response (CR) = Absence of enhancing tumor areas, reflecting complete tissue necrosis. Partial Response (PR) = A decrease > 50% of enhanced areas, reflecting partial tissue necrosis. Stable Disease (SD) = A tumor response between PR and PD. Progression (PD) = An increase > 25% in the size of > 1 measurable lesion(s) or the appearance of new lesions in the treated area (ie, specific segment or lobe of liver targeted by the intra-arterial infusion).
Measured: Up to 2 years
Secondary outcomes (1)
Number of Participants With Grade 3 or Higher Toxicity
Toxicity will be assessed according to CTCAE version 3.0
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start18 Oct 2004
- Primary completion28 May 2013
- Study completion6 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syma Iqbal, M.D., Principal investigator, U.S.C. / Norris Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183885
- Sponsor's protocol ID
- 3L-03-1
- Status last verified
- Oct 2025
- First submitted
- 9 Sep 2005
- Last updated
- 30 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Intra-arterial Chemotherapy With Cisplatin and Mitomycin-C
- ClinicalTrials.gov ID
- NCT00183885
- Acronym / sponsor ID
- 3L-03-1
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 18 Oct 2004 (actual)
- Primary completion
- 28 May 2013 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 30 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin + Mitomycin-C | Experimental | Drug: mitomycin-c, cisplatinCDDP 60mg/m2 + Mitomycin-C 12mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mitomycin-c, cisplatinIntra-arterial cisplatin 60 mg/m2 and mitomycin-C 12 mg/m2 every 8 weeks | Drug | Cisplatin + Mitomycin-C |
Primary outcome
Tumor Response
Time frame: Up to 2 years
A modified Response Evaluation Criteria In Solid Tumors (RECIST) will be used. The modification to RECIST is that although all lesions will be followed, only the treated lesions will be included in the assessment of response. Additionally, all lesions will be evaluated according to the following criteria: Presence of arterial enhancement: Yes or No. Complete Response (CR) = Absence of enhancing tumor areas, reflecting complete tissue necrosis. Partial Response (PR) = A decrease > 50% of enhanced areas, reflecting partial tissue necrosis. Stable Disease (SD) = A tumor response between PR and PD. Progression (PD) = An increase > 25% in the size of > 1 measurable lesion(s) or the appearance of new lesions in the treated area (ie, specific segment or lobe of liver targeted by the intra-arterial infusion).
1 secondary outcome
Number of Participants With Grade 3 or Higher Toxicity
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syma Iqbal, M.D. principal investigator
U.S.C. / Norris Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mitomycin-c, cisplatin in people with Hepatocellular Carcinoma and Liver Cancer, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Response (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.