Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103259
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2005-02-07
Brief Title:
Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Two Arm Trial of the Proteasome Inhibitor PS-341 Velcade TM in Combination With Irinotecan or PS-341 Alone Followed by the Addition of Irinotecan at Time of Progression in Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck SCCHN
Status:
COMPLETED
Status Verified Date:
2012-12
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 randomized phase II trial is studying bortezomib and irinotecan to see how well they work compared to bortezomib alone in treating patients with locally recurrent or metastatic squamous cell carcinoma of the head and neck Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as irinotecan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving bortezomib together with irinotecan may kill more tumor cells It is not yet known whether giving bortezomib together with irinotecan is more effective than bortezomib alone in treating head and neck cancer
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the activity of combination of PS-341 bortezomib and irinotecan in patients with locally advanced recurrent or metastatic squamous cell carcinoma of the head and neck SCCHN and the response rate of single agent PS-341 followed by irinotecan at time of progression
SECONDARY OBJECTIVES
I To continue exploring the toxicity of PS-341 alone and the combination of PS-341 and irinotecan in this patient population
II To evaluate time to progression overall survival and response to irinotecan and PS-341 when given after PS-341 alone
III To evaluate the relationship between pre-treatment nuclear localization of NF-kB and NF-kB regulated gene expression in tissue Cyclin D1 IAP1 Bcl-XL Topo I and serum IL-6 IL-8 GRO-1 and VEGF and response
OUTLINE Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 and irinotecan IV over 90 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Arm II Patients receive bortezomib as in arm I Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Upon disease progression patients may cross over to arm I
Patients are followed every 3-6 months for up to 3 years
I To evaluate the activity of combination of PS-341 bortezomib and irinotecan in patients with locally advanced recurrent or metastatic squamous cell carcinoma of the head and neck SCCHN and the response rate of single agent PS-341 followed by irinotecan at time of progression
SECONDARY OBJECTIVES
I To continue exploring the toxicity of PS-341 alone and the combination of PS-341 and irinotecan in this patient population
II To evaluate time to progression overall survival and response to irinotecan and PS-341 when given after PS-341 alone
III To evaluate the relationship between pre-treatment nuclear localization of NF-kB and NF-kB regulated gene expression in tissue Cyclin D1 IAP1 Bcl-XL Topo I and serum IL-6 IL-8 GRO-1 and VEGF and response
OUTLINE Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 and irinotecan IV over 90 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Arm II Patients receive bortezomib as in arm I Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Upon disease progression patients may cross over to arm I
Patients are followed every 3-6 months for up to 3 years
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-2012-02953 | REGISTRY | None | None |
| E1304 | OTHER | None | None |
| E1304 | OTHER | None | None |
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |