Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-30 @ 9:02 AM
Study NCT ID:
NCT00767468
Status:
TERMINATED
Last Update Posted:
2012-05-23
First Post:
2008-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sorafenib in Treating Patients With Locally Advanced or Metastatic Liver Cancer and Cirrhosis
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Phase IB Study of Sorafenib for Patient With Locally Advanced or Metastatic Hepatocellular Carcinoma and Child's B Cirrhosis
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding unavailable
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: 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.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib in treating patients with locally advanced or metastatic liver cancer and cirrhosis.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib in treating patients with locally advanced or metastatic liver cancer and cirrhosis.
Detailed Description:
OBJECTIVES:
Primary
* To evaluate the pharmacokinetic parameters of sorafenib tosylate in patients with locally advanced or metastatic hepatocellular carcinoma and Child-Pugh B cirrhosis.
* To correlate the pharmacokinetic parameters of sorfenib tosylate with hepatic retention and clearance of technetium Tc 99m mebrofenin (MEB) and technetium Tc 99m sestamibi (MIBI).
Secondary
* To establish a tolerable dose of sorafenib tosylate based on degree of liver dysfunction (bilirubin ≤ 3 times upper limit of normal \[ULN\] or bilirubin \> 3 times but ≤ 6 times ULN).
* To correlate the pharmacokinetics MEB and MIBI with the dose-limiting toxicity of sorafenib tosylate.
* To explore whether increase in bilirubin consists primarily of conjugated or unconjugated bilirubin in response to sorafenib tosylate.
* To explore whether there is a correlation between increased bilirubin and decreased clearance of MEB and/or MIBI.
* To explore whether there is a correlation between survival and MRI characteristics associated with high tumor VEGF levels.
* To assess VEGF levels directly in available biopsy samples using IHC.
* To determine expression levels of hepatic transport proteins (i.e., OATPs, Pgp, or MRPs) that may correlate with clearance of sorafenib tosylate.
* To explore whether there is a correlation between survival and activation of the RAF/MEK/ERK pathway at baseline.
* To estimate median overall survival.
OUTLINE: This is a multicenter study. Patients are stratified according to degree of hepatic dysfunction (moderate \[bilirubin ≤ 3 times upper limit of normal (ULN)\] vs severe \[bilirubin \> 3 times but ≤ 6 times ULN\]).
Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo hepatic scintigraphy with technetium Tc 99m mebrofinin (MEB) and technetium Tc 99m sestamibi (MIBI) at baseline. Blood and urine samples are collected periodically for pharmacokinetic studies.
After completion of study therapy, patients are followed at 3-4 weeks and then every 3 months thereafter.
Primary
* To evaluate the pharmacokinetic parameters of sorafenib tosylate in patients with locally advanced or metastatic hepatocellular carcinoma and Child-Pugh B cirrhosis.
* To correlate the pharmacokinetic parameters of sorfenib tosylate with hepatic retention and clearance of technetium Tc 99m mebrofenin (MEB) and technetium Tc 99m sestamibi (MIBI).
Secondary
* To establish a tolerable dose of sorafenib tosylate based on degree of liver dysfunction (bilirubin ≤ 3 times upper limit of normal \[ULN\] or bilirubin \> 3 times but ≤ 6 times ULN).
* To correlate the pharmacokinetics MEB and MIBI with the dose-limiting toxicity of sorafenib tosylate.
* To explore whether increase in bilirubin consists primarily of conjugated or unconjugated bilirubin in response to sorafenib tosylate.
* To explore whether there is a correlation between increased bilirubin and decreased clearance of MEB and/or MIBI.
* To explore whether there is a correlation between survival and MRI characteristics associated with high tumor VEGF levels.
* To assess VEGF levels directly in available biopsy samples using IHC.
* To determine expression levels of hepatic transport proteins (i.e., OATPs, Pgp, or MRPs) that may correlate with clearance of sorafenib tosylate.
* To explore whether there is a correlation between survival and activation of the RAF/MEK/ERK pathway at baseline.
* To estimate median overall survival.
OUTLINE: This is a multicenter study. Patients are stratified according to degree of hepatic dysfunction (moderate \[bilirubin ≤ 3 times upper limit of normal (ULN)\] vs severe \[bilirubin \> 3 times but ≤ 6 times ULN\]).
Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo hepatic scintigraphy with technetium Tc 99m mebrofinin (MEB) and technetium Tc 99m sestamibi (MIBI) at baseline. Blood and urine samples are collected periodically for pharmacokinetic studies.
After completion of study therapy, patients are followed at 3-4 weeks and then every 3 months thereafter.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA016086 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000615311 | OTHER | PDQ number | View | |
| BAYER-UNC-LCCC-0717 | None | None | View |