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NCT00183885

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

Completed Phase 2 Results posted Last updated 30 October 2025
What this trial tests

Phase 2 trial testing mitomycin-c, cisplatin in Hepatocellular Carcinoma in 76 participants. Completed in 6 March 2023.

Timeline
18 October 2004
Primary endpoint
28 May 2013
6 March 2023

Quick facts

Lead sponsorUniversity of Southern California
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment76
Start date18 October 2004
Primary completion28 May 2013
Estimated completion6 March 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Southern California

Who can join

18 and older, any sex, with Hepatocellular Carcinoma or Liver Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Tumor Response Primary · 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 P

CR
GroupValue95% CI
Cisplatin + Mitomycin-C0
PR
GroupValue95% CI
Cisplatin + Mitomycin-C7
SD
GroupValue95% CI
Cisplatin + Mitomycin-C47
PD
GroupValue95% CI
Cisplatin + Mitomycin-C11
Inevaluable for Response
GroupValue95% CI
Cisplatin + Mitomycin-C11
Number of Participants With Grade 3 or Higher Toxicity Secondary · Up to 1 year

Toxicity will be assessed according to CTCAE version 3.0

GroupValue95% CI
Cisplatin + Mitomycin-C75

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cisplatin + Mitomycin-C
Serious: 51/76 (67%)
Deaths: 44/76

Serious adverse events (29 terms)

ReactionSystemCisplatin + Mitomycin-C
PlateletsBlood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)Blood and lymphatic system disorders
Fatigue (asthenia, lethargy, malaise)General disorders
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
Abdominal painGastrointestinal disorders
NauseaGastrointestinal disorders
VomitingGastrointestinal disorders
AnorexiaGeneral disorders
Blood bilirubin increasedInvestigations
HyperglycemiaMetabolism and nutrition disorders
LeukocytesBlood and lymphatic system disorders
HemoglobinBlood and lymphatic system disorders
DehydrationGastrointestinal disorders
DiarrheaGastrointestinal disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)General disorders
ConstipationGastrointestinal disorders
Esophageal hemorrhageGastrointestinal disorders
Lower gastrointestinal hemorrhageGastrointestinal disorders
Liver dysfunction/failure (clinical)Hepatobiliary disorders
Edema limbGeneral disorders
Alkaline phosphatase increasedInvestigations
Creatinine increasedInvestigations
HyperkalemiaMetabolism and nutrition disorders
HyponatremiaMetabolism and nutrition disorders
Other adverse events (72 terms — click to expand)

ReactionSystemCisplatin + Mitomycin-C
Hemoglobin decreasedBlood and lymphatic system disorders
Fatigue (asthenia, lethargy, malaise)General disorders
AnorexiaGastrointestinal disorders
Bilirubin (hyperbilirubinemia)Metabolism and nutrition disorders
Platelets decreasedBlood and lymphatic system disorders
NauseaGastrointestinal disorders
AST (SGOT) increasedMetabolism and nutrition disorders
Alkaline phosphatase increasedMetabolism and nutrition disorders
ALT (SGPT) increasedMetabolism and nutrition disorders
Edema: limbGeneral disorders
Pain (Abdomen NOS)Gastrointestinal disorders
Neutrophils/granulocytes (ANC/AGC)Blood and lymphatic system disorders
DizzinessNervous system disorders
Albumin, serum-low (hypoalbuminemia)Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)Metabolism and nutrition disorders
DiarrheaGastrointestinal disorders
VomitingGastrointestinal disorders
Creatinine increasedMetabolism and nutrition disorders
Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)Gastrointestinal disorders
Injection site reaction/extravasation changesGeneral disorders
ConstipationGastrointestinal disorders
CoughRespiratory, thoracic and mediastinal disorders
AlopeciaSkin and subcutaneous tissue disorders
Ascites (non-malignant)Gastrointestinal disorders
Sodium, serum-low (hyponatremia)Metabolism and nutrition disorders
Rash/desquamationSkin and subcutaneous tissue disorders
Potassium, serum-low (hypokalemia)Metabolism and nutrition disorders
ConfusionNervous system disorders
Pain (Head/headache)Nervous system disorders
TinnitusEar and labyrinth disorders
Leukocytes (total WBC) decreasedBlood and lymphatic system disorders
Pruritus/itchingSkin and subcutaneous tissue disorders
Magnesium, serum-low (hypomagnesemia)Metabolism and nutrition disorders
Mood alteration (Anxiety)Nervous system disorders
Neuropathy: sensoryNervous system disorders
InsomniaGeneral disorders
DehydrationGastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) (Oral cavity)Gastrointestinal disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)Skin and subcutaneous tissue disorders

Most-reported serious reactions: Platelets, Neutrophils/granulocytes (ANC/AGC), Fatigue (asthenia, lethargy, malaise), Alanine aminotransferase increased, Aspartate aminotransferase increased, Abdominal pain, Nausea, Vomiting.

Data from ClinicalTrials.gov NCT00183885 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Techniques of interventional tumor therapy.
    Mahnken AH, Bruners P, Günther RW. · · 2008 · cited 8× · PMID 19471636 · DOI 10.3238/arztebl.2008.0646

Verify or expand the search:

Other recruiting trials for Hepatocellular Carcinoma

Currently open trials in the same condition.

Other University of Southern California trials

Trials by the same sponsor.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00183885.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing