Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085410
Status:
TERMINATED
Last Update Posted:
2017-07-02
First Post:
2004-06-10
Brief Title:
Bortezomib in Treating Patients With Unresectable Locally Advanced or Metastatic Adenocarcinoma of the Bile Duct or Gallbladder
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II and Pharmacodynamic Study of PS-341 in Patients With Unresectable or Metastatic Adenocarcinoma of the Bile Duct or Gallbladder
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial was discontinued early due to no confirmed partial responses
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 bortezomib works as first-line systemic therapy in treating patients with unresectable locally advanced or metastatic adenocarcinoma cancer of the bile duct or gallbladder Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine the objective response rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the bile duct or gallbladder treated with bortezomib
SECONDARY OBJECTIVES
I Determine the time to disease progression in patients treated with this drug
II Determine the overall survival of patients treated with this drug III Correlate the degree of proteasome inhibition in peripheral blood with degree of proteasome inhibition in tumor specimens of patients treated with this drug
IV Correlate phenotypic expression of NF-kB p53 and other molecular markers in biliary washings and tumor biopsies with clinical outcomes in patients treated with this drug
V Correlate treatment with this drug with changes in phenotypic expression of molecular markers in these patients
OUTLINE This is an open-label multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year
I Determine the objective response rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the bile duct or gallbladder treated with bortezomib
SECONDARY OBJECTIVES
I Determine the time to disease progression in patients treated with this drug
II Determine the overall survival of patients treated with this drug III Correlate the degree of proteasome inhibition in peripheral blood with degree of proteasome inhibition in tumor specimens of patients treated with this drug
IV Correlate phenotypic expression of NF-kB p53 and other molecular markers in biliary washings and tumor biopsies with clinical outcomes in patients treated with this drug
V Correlate treatment with this drug with changes in phenotypic expression of molecular markers in these patients
OUTLINE This is an open-label multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year
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 |
|---|---|---|---|
| 6135 | OTHER | CTEP | None |
| NCI-2009-00046 | REGISTRY | None | None |
| CDR0000369715 | None | None | None |
| 03-042 | None | None | None |
| 03-042 | OTHER | None | None |