Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002888
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Head and Neck Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A RANDOMIZED PHASE III EVALUATION OF PACLITAXEL G-CSF CISPLATIN VERSUS CISPLATIN 5-FU IN ADVANCED HEAD AND NECK CANCER
Status:
COMPLETED
Status Verified Date:
2007-05
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 It is not yet known whether cisplatin plus fluorouracil are more effective than paclitaxel plus cisplatin in treating patients with advanced head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with advanced head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with advanced head and neck cancer
Detailed Description:
OBJECTIVES I Compare the response rate toxicity quality-of-life and overall survival at 1 year in patients with advanced head and neck carcinomas when treated with paclitaxel and cisplatin vs cisplatin and fluorouracil II Compare these regimens in terms of quality of life and correlate quality of life to toxicity in these patients III Compare these regimens in terms of pain intensity and correlate pain with quality of life and toxicity in these patients
OUTLINE This is a randomized study Patients are stratified by disease status performance status and participating institution Patients are randomized to one of two treatment arms Arm I Patients receive cisplatin IV over 30-120 minutes on day 1 and fluorouracil IV over 96 hours on days 1-4 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Arm II Patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 30-120 minutes on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Treatment continues until 2 courses past complete response minimum of 6 courses Patients with stable disease may discontinue treatment after 6 courses Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 212 patients will be accrued for this study over 225 years
OUTLINE This is a randomized study Patients are stratified by disease status performance status and participating institution Patients are randomized to one of two treatment arms Arm I Patients receive cisplatin IV over 30-120 minutes on day 1 and fluorouracil IV over 96 hours on days 1-4 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Arm II Patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 30-120 minutes on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Treatment continues until 2 courses past complete response minimum of 6 courses Patients with stable disease may discontinue treatment after 6 courses Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 212 patients will be accrued for this study over 225 years
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 |
|---|---|---|---|
| SWOG-E1395 | None | None | None |
| E-1395 | None | None | None |