Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT00387335
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
2006-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Sunitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase II Study of Sunitinib Malate in Head and Neck Squamous Cell Carcinoma
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 phase II trial is studying how well sunitinib works in treating patients with recurrent and/or metastatic head and neck cancer. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Detailed Description:
OBJECTIVES:
I. Determine the overall response rate of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with sunitinib malate.
II. Determine the toxicity of this drug in these patients. III. Determine the feasibility of administering this drug to patients with ECOG performance status 2 (cohort B).
OUTLINE: This is a multicenter, cohort study.
Patients are assigned to one of two cohorts according to ECOG performance status (ECOG 0-1 \[cohort A\] vs ECOG 2 \[cohort B\]). Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 1 year.
I. Determine the overall response rate of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with sunitinib malate.
II. Determine the toxicity of this drug in these patients. III. Determine the feasibility of administering this drug to patients with ECOG performance status 2 (cohort B).
OUTLINE: This is a multicenter, cohort study.
Patients are assigned to one of two cohorts according to ECOG performance status (ECOG 0-1 \[cohort A\] vs ECOG 2 \[cohort B\]). Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 1 year.
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 |
|---|---|---|---|---|
| 7738 | OTHER | CTEP | View | |
| N01CM62201 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA014599 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2009-00214 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000504024 | None | None | View | |
| 7738 | OTHER | University of Chicago | View |