Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248560
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2005-11-03
Brief Title:
Gemcitabine and Docetaxel in Treating Patients With Persistent Recurrent or Metastatic Head and Neck Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase II Study of Gemcitabine and Docetaxel GEMDOC Combination in Patients With Previously Treated Recurrent or Metatstatic Squamous Cell Carcinoma of the Head and Neck SCCHN
Status:
COMPLETED
Status Verified Date:
2019-02
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 docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving gemcitabine together with docetaxel 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 docetaxel works in treating patients with persistent recurrent or metastatic head and neck cancer
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with previously treated persistent recurrent or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and docetaxel
Secondary
Determine the toxicity of this regimen in these patients
Determine the duration of response and survival of patients treated with this regimen
OUTLINE Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 60 minutes on day 1 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 4 additional courses of therapy beyond documentation of CR
After completion of study treatment patients are followed for survival
PROJECTED ACCRUAL A total of 17-41 patients will be accrued within 42-49 months
Primary
Determine the response rate in patients with previously treated persistent recurrent or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and docetaxel
Secondary
Determine the toxicity of this regimen in these patients
Determine the duration of response and survival of patients treated with this regimen
OUTLINE Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 60 minutes on day 1 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 4 additional courses of therapy beyond documentation of CR
After completion of study treatment patients are followed for survival
PROJECTED ACCRUAL A total of 17-41 patients will be accrued within 42-49 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 |
|---|---|---|---|
| WSU-HIC-120904M1F | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |
| WSU-D-2830 | None | None | None |