Phase 2 Completed N=50 Treatment

Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver

Liver Cancer · Metastatic cancer

Source: ClinicalTrials.gov NCT00003907 ↗

Enrolled (actual)

Serious AEs

98.0%

Results posted

Feb 2013

Primary outcomePrimary: Time to Progression — 2.3; 7.2 Months

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.

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	—

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.

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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. Informational only — not medical advice.