Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006248
Status:
COMPLETED
Last Update Posted:
2013-04-10
First Post:
2000-09-11
Brief Title:
S0007 - Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Evaluation of Three Hour Infusion of Paclitaxel Plus Cisplatin and 5-Fluorouracil in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck SCCHN
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or recurrent head and neck cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or recurrent head and neck cancer
Detailed Description:
OBJECTIVES
Determine the overall survival of patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with paclitaxel cisplatin and fluorouracil
Determine response unconfirmed confirmed complete and partial and time to treatment failure in patients with measurable disease treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE Patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 30 minutes on day 1 and fluorouracil IV over 24 hours on days 1-4 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 3 additional courses beyond CR
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 65 patients will be accrued for this study within 12 months
Determine the overall survival of patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with paclitaxel cisplatin and fluorouracil
Determine response unconfirmed confirmed complete and partial and time to treatment failure in patients with measurable disease treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE Patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 30 minutes on day 1 and fluorouracil IV over 24 hours on days 1-4 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 3 additional courses beyond CR
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 65 patients will be accrued for this study within 12 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 |
|---|---|---|---|
| S0007 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |