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CompletedNCT00183885Updated Oct 30, 2025Results posted

A Phase II Study of Intra-arterial Chemotherapy With Cisplatin and Mitomycin-C in Patients With Hepatocellular Carcinoma

A Phase 2 interventional study of mitomycin-c, cisplatin in Hepatocellular Carcinoma and Liver Cancer, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-30.

Sponsored by University of Southern California · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Oct 2004, registered Sep 2005).
Phase
Phase 2
Study type
Interventional
Enrollment
76
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatocellular Carcinoma
  • Liver Cancer
03

In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's enrollment of 76 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    Cisplatin + Mitomycin-C

    CDDP 60mg/m2 + Mitomycin-C 12mg/m2

    Drug: mitomycin-c, cisplatin

Interventions

  • Drugmitomycin-c, cisplatin

    Intra-arterial cisplatin 60 mg/m2 and mitomycin-C 12 mg/m2 every 8 weeks

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 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

    Time frame: Up to 1 year

07

Results

Posted Oct 30, 2025

Participant flow

Recruitment for this study opened in October 2004 and closed in February 2012. All subjects were seen and treated in the medical clinics at the University of Southern California.

Participant flow — Overall Study
MilestoneCisplatin + Mitomycin-C
Started76
Completed37
Not completed39
Withdrew: Adverse event11
Withdrew: Death1
Withdrew: Lost to follow-up3
Withdrew: Physician decision6
Withdrew: Withdrawal by subject5
Withdrew: Switched to alternative treatment8
Withdrew: Treatment delayed too long4
Withdrew: Developed second malignancy1

Outcome measures

PrimaryTumor 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).

Time frame:
Up to 2 years
Reported as:
Count of participants · Participants
Tumor Response
ParticipantsCisplatin + Mitomycin-C
CR0
PR7
SD47
PD11
Inevaluable for Response11
SecondaryNumber of Participants With Grade 3 or Higher Toxicity

Toxicity will be assessed according to CTCAE version 3.0

Time frame:
Up to 1 year
Reported as:
Count of participants · Participants
Number of Participants With Grade 3 or Higher Toxicity
ParticipantsCisplatin + Mitomycin-C
Number of Participants With Grade 3 or Higher Toxicity75

Adverse events

Collected over Up to 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cisplatin + Mitomycin-C44/76 (57.9%)51/76 (67.1%)75/76 (98.7%)
Most frequent serious events
Showing 10 of 29
Most frequent serious events
EventCisplatin + Mitomycin-C
PlateletsBlood and lymphatic system disorders27/76
Neutrophils/granulocytes (ANC/AGC)Blood and lymphatic system disorders19/76
Fatigue (asthenia, lethargy, malaise)General disorders9/76
Alanine aminotransferase increasedInvestigations8/76
Aspartate aminotransferase increasedInvestigations8/76
Abdominal painGastrointestinal disorders8/76
NauseaGastrointestinal disorders7/76
VomitingGastrointestinal disorders6/76
AnorexiaGeneral disorders5/76
Blood bilirubin increasedInvestigations5/76
Most frequent other events
Showing 10 of 72
Most frequent other events
EventCisplatin + Mitomycin-C
Hemoglobin decreasedBlood and lymphatic system disorders60/76
Fatigue (asthenia, lethargy, malaise)General disorders53/76
AnorexiaGastrointestinal disorders42/76
Bilirubin (hyperbilirubinemia)Metabolism and nutrition disorders42/76
Platelets decreasedBlood and lymphatic system disorders39/76
NauseaGastrointestinal disorders38/76
AST (SGOT) increasedMetabolism and nutrition disorders38/76
Alkaline phosphatase increasedMetabolism and nutrition disorders37/76
ALT (SGPT) increasedMetabolism and nutrition disorders33/76
Edema: limbGeneral disorders23/76

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Cisplatin + Mitomycin-C
Mean61 (41 to 76)
Sex: Female, Male
Sex: Female, Male(Participants)Cisplatin + Mitomycin-C
Female18
Male58
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cisplatin + Mitomycin-C
Hispanic or Latino32
Not Hispanic or Latino44
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cisplatin + Mitomycin-C
American Indian or Alaska Native0
Asian23
Native Hawaiian or Other Pacific Islander0
Black or African American6
White18
More than one race0
Unknown or Not Reported29
Region of Enrollment
Region of Enrollment(participants)Cisplatin + Mitomycin-C
United States76
08

Study locations

1 site
  • U.S.C. / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 1, 2010

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00183885
Lead sponsor
University of Southern California
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
Oct 18, 2004
Primary completion
May 28, 2013
Completion
Mar 6, 2023
Results posted
Oct 30, 2025
Last update
Oct 30, 2025

Study contacts

Syma Iqbal, M.D.
principal investigator · U.S.C. / Norris Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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