CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
cisplatin +3 moredrug
Likely dose
Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg dissolved in 10-15 mL of contrast agent, delivered via transarterial chemoembolization with gelatin sponge particulate embolizationAI-extracted
Key inclusion· 8
  • Biopsy-proven intrahepatic hepatocellular carcinoma or neuroendocrine tumor
  • Unresectable disease
  • Bidimensionally measurable disease on imaging (CT, MRI, or ultrasound) within 6 weeks of registration
  • Patent portal vasculature confirmed by Doppler ultrasound, MRI, or angiography
Key exclusion· 5
  • Extrahepatic disease likely to be life-threatening within 3 months, such as brain or symptomatic lung metastases
  • Prior intra-arterial or intra-hepatic chemotherapy or systemic chemotherapy within 4 weeks
  • Concurrent malignancy
  • Pregnant or breast-feeding women

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00003907
NCT00003907Phase 2Completed

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

Eastern Cooperative Oncology Group·interventional·Posted Oct 9, 2003·Updated Jul 5, 2023

In Brief

A Phase 2 clinical trial evaluating cisplatin, doxorubicin, and 2 other interventions for Liver Cancer and Metastatic Cancer. Completed, enrolled 50 participants across 37 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 9, 2003
Enrollment StartDec 15, 1999
Primary CompletionMay 1, 2011
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11.4 yearsPosted 22.7 years ago

Interventions

cisplatindrug

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).

doxorubicindrug

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).

mitomycindrug

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).

embolizationprocedure

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.