CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Carboplatin +2 moredrug
Likely dose
Sorafenib 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00875615
NCT00875615Phase 2Completed

Phase II Trial of Intrahepatic Artery Chemotherapy With Nexavar in Hepatocellular Carcinoma Patients

University of Miami·interventional·Posted Apr 3, 2009·Updated Feb 7, 2017

In Brief

A Phase 2 clinical trial evaluating Carboplatin, Cisplatin, and 1 other intervention for Liver Cancer. Completed, enrolled 11 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Infusing chemotherapy directly into the liver and giving it together with sorafenib may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of infusing cisplatin or carboplatin directly into the liver and giving it together with sorafenib in treating patients with liver cancer that cannot be removed by surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 3, 2009
Enrollment StartDec 1, 2008
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 17.2 years ago

Interventions

Carboplatindrug

Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.

Cisplatindrug

Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.

Sorafenibdrug

Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.