Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-02 @ 3:14 AM
Study NCT ID:
NCT00103259
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2005-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
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:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-02953 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| E1304 | OTHER | Eastern Cooperative Oncology Group | View | |
| E1304 | OTHER | CTEP | View | |
| U10CA021115 | NIH | None | https://reporter.nih.gov/quic… | View |