Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052507
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2003-01-24
Brief Title:
Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase II Study Of PS-341 In Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2015-07
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:
RATIONALE Bortezomib may interfere with the growth of tumor cells by blocking the enzymes necessary for cancer cell growth
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have metastatic or recurrent colorectal cancer
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have metastatic or recurrent colorectal cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of bortezomib in terms of response rate and stable disease rate in patients with recurrent or metastatic colorectal cancer
Determine the toxicity of this drug in these patients
Determine the time to progression and response duration in patients treated with this drug
Determine whether there is a relationship between levels of transcription factors NF kappa B and HIF-1 alpha and clinical outcome in patients treated with this drug
OUTLINE This is an open-label study
Patients receive bortezomib IV on days 1 4 8 and 11 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 21-41 patients will be accrued for this study within 2-4 months
Determine the efficacy of bortezomib in terms of response rate and stable disease rate in patients with recurrent or metastatic colorectal cancer
Determine the toxicity of this drug in these patients
Determine the time to progression and response duration in patients treated with this drug
Determine whether there is a relationship between levels of transcription factors NF kappa B and HIF-1 alpha and clinical outcome in patients treated with this drug
OUTLINE This is an open-label study
Patients receive bortezomib IV on days 1 4 8 and 11 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 21-41 patients will be accrued for this study within 2-4 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 |
|---|---|---|---|
| NCI-5890 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000258488 | REGISTRY | None | None |