Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00507767
Status:
COMPLETED
Last Update Posted:
2014-10-01
First Post:
2007-07-26
Brief Title:
Dasatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of Dasatinib in Head and Neck Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-04
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 studies how well dasatinib works in treating patients with head and neck cancer that has come back or spread to other areas of the body Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the 12-week progression-free survival rate and the objective response rate as measured by Response Evaluation Criteria in Solid Tumors RECIST criteria in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with dasatinib
SECONDARY OBJECTIVES
I To define metabolic response rate by positron emission tomography PET scan at 0 8 and 12 weeks
II To define overall survival distribution from initiation of dasatinib III To define duration of response IV To determine if there is a correlation between clinical benefit from dasatinib defined as disease response or stabilization and pharmacokinetics pharmacodynamics phosphorylated Src pSrc expression in platelets or changes in serum levels of cytokines growth factors and growth factor receptors relevant to the Src signaling pathway
V To examine the relationship between clinical benefit and mammary tumor and squamous cell carcinoma-associated protein EMS1 gene amplification and cortactin expression levels in tumor tissue prior to therapy and the modulation of cortactin levels by treatment
VI To compare the effects of dasatinib on apoptosis by terminal deoxynucleotidyl transferase dUTP nick end labeling TUNEL assay in tumor tissues comparing pre- and post-treatment biopsies
VII To assess the tolerability of dasatinib in this patient population VIII To describe the pharmacokinetic PK profile and relative bioavailability of dasatinib suspension in patients receiving the drug through percutaneous gastrostomy tube
IX To descriptively assess safety toxicity and efficacy of dasatinib crushed and administered by feeding tube
OUTLINE
Patients receive dasatinib orally PO or via percutaneous gastrostomy PEG tube twice daily BID Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for at least 4 weeks
I To determine the 12-week progression-free survival rate and the objective response rate as measured by Response Evaluation Criteria in Solid Tumors RECIST criteria in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with dasatinib
SECONDARY OBJECTIVES
I To define metabolic response rate by positron emission tomography PET scan at 0 8 and 12 weeks
II To define overall survival distribution from initiation of dasatinib III To define duration of response IV To determine if there is a correlation between clinical benefit from dasatinib defined as disease response or stabilization and pharmacokinetics pharmacodynamics phosphorylated Src pSrc expression in platelets or changes in serum levels of cytokines growth factors and growth factor receptors relevant to the Src signaling pathway
V To examine the relationship between clinical benefit and mammary tumor and squamous cell carcinoma-associated protein EMS1 gene amplification and cortactin expression levels in tumor tissue prior to therapy and the modulation of cortactin levels by treatment
VI To compare the effects of dasatinib on apoptosis by terminal deoxynucleotidyl transferase dUTP nick end labeling TUNEL assay in tumor tissues comparing pre- and post-treatment biopsies
VII To assess the tolerability of dasatinib in this patient population VIII To describe the pharmacokinetic PK profile and relative bioavailability of dasatinib suspension in patients receiving the drug through percutaneous gastrostomy tube
IX To descriptively assess safety toxicity and efficacy of dasatinib crushed and administered by feeding tube
OUTLINE
Patients receive dasatinib orally PO or via percutaneous gastrostomy PEG tube twice daily BID Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for at least 4 weeks
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 |
|---|---|---|---|
| P30CA016672 | NIH | CTEP | httpsreporternihgovquickSearchP30CA016672 |
| NCI-2009-00227 | REGISTRY | None | None |
| CDR0000559148 | None | None | None |
| 2006-0571 | OTHER | None | None |
| 7815 | OTHER | None | None |
| N01CM62202 | NIH | None | None |