Phase 2
N=50
Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver
Liver Cancer · Metastatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00003907 ↗Enrolled (actual)
50
Serious AEs
98.0%
Results posted
Feb 2013
Primary outcome: Primary: Time to Progression — 2.3; 7.2 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cisplatin (Drug); doxorubicin (Drug); mitomycin (Drug); embolization (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eastern Cooperative Oncology Group
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression |
2.3; 7.2 | — |
| SECONDARY Tumor Response |
0; 0.17 | — |
| SECONDARY Overall Survival |
12.0; 21.2 | — |
Summary
RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor.
PURPOSE: Phase II trial to study the effectiveness of chemoembolization in treating patients who have primary liver cancer or metastases to the liver that cannot be surgically removed.
Eligibility Criteria
Inclusion Criteria
- Biopsy-proven intrahepatic hepatocellular carcinoma or neuroendocrine tumor.
- Unresectable.
- Bidimensionally measurable disease by Computed Tomography (CT), Magnetic resonance imaging (MRI), or UltraSound Scanning (US) within 6 weeks of registration.
- Evidence of patent portal vasculature by Doppler US, MRI, or angiography.
- Serum total bilirubin 2000/µl and platelets > 50,000/µl within 4 weeks of registration.
- Expected survival of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Age >= 18 years.
Exclusion Criteria
- Evidence of extrahepatic disease that is likely to be life-threatening within 3 months, such as brain or symptomatic lung metastases.
- Previous intra-arterial or intra-hepatic chemotherapy or prior systemic chemotherapy within 4 weeks.
- Concurrent malignancy.
- Pregnant or breast-feeding women.
- History of life-threatening contrast allergy.
Data sourced from ClinicalTrials.gov (NCT00003907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.