Clinical trial

Chemoembolization in Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases: A Phase II Multi-Center Trial

Name

CDR0000067083

Description

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.

Trial arms

Trial start

1999-12-15

Estimated PCD

2011-05-01

Trial end

2012-08-01

Status

Completed

Phase

Early phase I

Treatment

cisplatin

Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).

Arms:

Hepatocellular carcinoma, Neuroendocrine hepatic metastases

Other names:

Cis-diaminedichloroplatinum Cis-diaminedichloroplatinum (II),, diaminedichloroplatinum,, cis-platinum,, platinum,, Platinol,, Platinol-AQ,, DDP,, CDDP,, DACP,, NSC 119875

doxorubicin

Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).

Arms:

Hepatocellular carcinoma, Neuroendocrine hepatic metastases

Other names:

Adriamycin,, Rubex,, Adriamycin RDF,, Adriamycin PFS,, hydroxydaunorubicin,, hydroxydaunomycin,, ADR

mitomycin

Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).

Arms:

Hepatocellular carcinoma, Neuroendocrine hepatic metastases

Other names:

Mutamycin,

embolization

Immediately following delivery of the chemoemulsion, particulate embolization is performed. The particulate embolic material is prepared on a separate table or tray, using absorbable gelatin sponge (Gelfoam, Upjohn, Kalamazoo, MI), in either powder or pledget form. Approximately 1 g of this temporary occlusive agent is dissolved in 20-30 cc of full-strength contrast with 2.4 cc of absolute alcohol.

Arms:

Hepatocellular carcinoma, Neuroendocrine hepatic metastases

Other names:

trans-arterial chemoembolization,, TACE

Size

Primary endpoint

Time to Progression

Assessed every 3 months for 2 years, then every 6 months for 3 year.

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 \< 2.0 mg/dl and serum creatinine \< 2.0 mg/dl within 4 weeks of registration. * Absolute neutrophil count (ANC) \> 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}

Updated at

2023-07-05

1 organization

2 products

1 drug

2 indications

Organization

Eastern Cooperative Oncology Group

Product

Indication

Indication

Drug

Product