Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083226
Status:
COMPLETED
Last Update Posted:
2014-10-30
First Post:
2004-05-14
Brief Title:
Doxorubicin and Bortezomib in Treating Patients With Liver Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Bortezomib Plus Doxorubicin in Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial is studying how well giving doxorubicin together with bortezomib works in treating patients with liver cancer Drugs used in chemotherapy such as doxorubicin work in different ways to stop tumor cells from dividing so they stop growing or die Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Giving doxorubicin together with bortezomib may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the tumor response rate in patients with hepatocellular carcinoma HCC
SECONDARY OBJECTIVES
I To determine other parameters of antitumor effect including time to tumor progression and overall survival in HCC patients treated with bortezomib and doxorubicin
II To observe toxicity profile of bortezomib and doxorubicin in patients with hepatocellular carcinoma
III To evaluate proteasome 20S inhibition in tumor tissue including proteins such as p21 p27 p53 Bax and Bcl-2 which are affected by proteasome 26S and compare them to clinical parameters using biopsy specimens obtained from patients with HCC treated with bortezomib Withdrawn as of 03-2007
IV To measure phosphorylation of IkB in tumor tissue and compare to clinical parameters using biopsy specimens obtained from patients with HCC treated with bortezomib Withdrawn as of 03-2007
V To evaluate the effect of bortezomib on 26S proteasome activity in peripheral white blood cells WBCs and patient serum Direct measurement of 26S proteasome activity as well as proteins affected by proteasome 26S and Nuclear factor kappa-B NF-kB will be analyzed Withdrawn as of 03-2007
OUTLINE This is a multicenter study
Patients receive doxorubicin intravenously IV over 5-15 minutes on days 1 and 8 Patients also receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 13 months
I To evaluate the tumor response rate in patients with hepatocellular carcinoma HCC
SECONDARY OBJECTIVES
I To determine other parameters of antitumor effect including time to tumor progression and overall survival in HCC patients treated with bortezomib and doxorubicin
II To observe toxicity profile of bortezomib and doxorubicin in patients with hepatocellular carcinoma
III To evaluate proteasome 20S inhibition in tumor tissue including proteins such as p21 p27 p53 Bax and Bcl-2 which are affected by proteasome 26S and compare them to clinical parameters using biopsy specimens obtained from patients with HCC treated with bortezomib Withdrawn as of 03-2007
IV To measure phosphorylation of IkB in tumor tissue and compare to clinical parameters using biopsy specimens obtained from patients with HCC treated with bortezomib Withdrawn as of 03-2007
V To evaluate the effect of bortezomib on 26S proteasome activity in peripheral white blood cells WBCs and patient serum Direct measurement of 26S proteasome activity as well as proteins affected by proteasome 26S and Nuclear factor kappa-B NF-kB will be analyzed Withdrawn as of 03-2007
OUTLINE This is a multicenter study
Patients receive doxorubicin intravenously IV over 5-15 minutes on days 1 and 8 Patients also receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 13 months
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA021115 | NIH | Eastern Cooperative Oncology Group | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2012-02952 | REGISTRY | None | None |
| E6202 | OTHER | None | None |