Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458978
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2007-04-09
Brief Title:
Cediranib Maleate in Treating Patients With Recurrent or Newly Diagnosed Metastatic Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Clinical Trial of AZD2171 Monotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Patients
Status:
COMPLETED
Status Verified Date:
2014-04
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 cediranib maleate works in treating patients with recurrent or newly diagnosed metastatic head and neck cancer Cediranib maleate may stop the growth of head and neck cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Determine the objective clinical response in patients with recurrent or newly diagnosed metastatic squamous cell carcinoma of the head and neck treated with AZD2171 cediranib maleate
SECONDARY OBJECTIVES
I Determine the safety profile of this drug in these patients II Assess the early and late physiological and biological effects of this drug on tumor interstitial fluid pressure pO2 and tumor microvasculature
III Assess the value of potential noninvasive biomarkers of response including plasma levels of molecules involved in angiogenesis circulating endothelial cells and progenitor cells and functional imaging changes before and after treatment
IV Assess the gene expression patterns before and after treatment as predictors of clinical and biological response
OUTLINE This is a multicenter study
Patients receive oral cediranib maleate once daily on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients undergo dynamic contrast-enhanced CT imaging and blood collection periodically during study for research studies assessing plasma levels of angiogenicantiangiogenic molecules circulating endothelial cells by flow cytometry progenitor cells and protein analysis of potential biomarkers
I Determine the objective clinical response in patients with recurrent or newly diagnosed metastatic squamous cell carcinoma of the head and neck treated with AZD2171 cediranib maleate
SECONDARY OBJECTIVES
I Determine the safety profile of this drug in these patients II Assess the early and late physiological and biological effects of this drug on tumor interstitial fluid pressure pO2 and tumor microvasculature
III Assess the value of potential noninvasive biomarkers of response including plasma levels of molecules involved in angiogenesis circulating endothelial cells and progenitor cells and functional imaging changes before and after treatment
IV Assess the gene expression patterns before and after treatment as predictors of clinical and biological response
OUTLINE This is a multicenter study
Patients receive oral cediranib maleate once daily on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients undergo dynamic contrast-enhanced CT imaging and blood collection periodically during study for research studies assessing plasma levels of angiogenicantiangiogenic molecules circulating endothelial cells by flow cytometry progenitor cells and protein analysis of potential biomarkers
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 |
|---|---|---|---|
| R21CA119591 | NIH | CTEP | httpsreporternihgovquickSearchR21CA119591 |
| NCI-2009-00148 | REGISTRY | None | None |
| CDR0000538287 | None | None | None |
| MGH-06-264 | None | None | None |
| 06-264 | OTHER | None | None |
| 7309 | OTHER | None | None |
| P30CA006516 | NIH | None | None |