Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100789
Status:
COMPLETED
Last Update Posted:
2012-10-01
First Post:
2005-01-06
Brief Title:
S0329 Gemcitabine and Paclitaxel in Treating Patients With Persistent Recurrent or Metastatic Head and Neck Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Study of Biweekly Gemcitabine and Paclitaxel GEMTAX Combination in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck SCCHN
Status:
COMPLETED
Status Verified Date:
2012-08
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:
RATIONALE Drugs used in chemotherapy such as gemcitabine and paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving gemcitabine together with paclitaxel may kill more tumor cells
PURPOSE This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent recurrent or metastatic head and neck cancer
PURPOSE This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent recurrent or metastatic head and neck cancer
Detailed Description:
OBJECTIVES
Determine overall and progression-free survival probability in patients with persistent recurrent or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and paclitaxel
Determine the confirmed and unconfirmed response partial and complete probability in patients with measurable disease treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 4 additional courses beyond CR
Patients are followed every 8 weeks until disease progression every 6 month for 2 years and then annually for 1 year
PROJECTED ACCRUAL A total of 65 patients will be accrued for this study within 10-13 months
Determine overall and progression-free survival probability in patients with persistent recurrent or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and paclitaxel
Determine the confirmed and unconfirmed response partial and complete probability in patients with measurable disease treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 4 additional courses beyond CR
Patients are followed every 8 weeks until disease progression every 6 month for 2 years and then annually for 1 year
PROJECTED ACCRUAL A total of 65 patients will be accrued for this study within 10-13 months
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0329 | OTHER | None | None |