Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003592
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Methotrexate Compared With Paclitaxel in Treating Patients With Advanced Head and Neck Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase III Randomized Trial of Methotrexate vs Paclitaxel in Cisplatin-Ineligible Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2023-06
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 It is not yet known whether methotrexate or paclitaxel is more effective in treating patients with advanced head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of methotrexate with that of paclitaxel in treating patients who have advanced head and neck cancer that cannot be treated with cisplatin
PURPOSE Randomized phase III trial to compare the effectiveness of methotrexate with that of paclitaxel in treating patients who have advanced head and neck cancer that cannot be treated with cisplatin
Detailed Description:
OBJECTIVES I Compare the progression free survival median survival and overall survival in cisplatin-ineligible patients with advanced squamous cell carcinoma of the head and neck following weekly outpatient methotrexate arm I versus paclitaxel arm II II Compare the response rate of patients in the two treatment arms III Compare the Trial Outcome Index scores of patients in the two treatment arms IV Compare the weight change neurologic toxicity and mucositis scores of patients in the two treatment arms
OUTLINE This is a randomized study Patients are stratified by performance status 0-1 vs 2 and age less than 60 vs at least 60 Patients are randomized to receive methotrexate IV bolus every week for 4 weeks arm I or paclitaxel IV over 1 hour every week for 4 weeks arm II All patients receive at least 4 weeks of treatment 1 course Patients continue treatment for a total of 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years every 6 months for 3 years and annually thereafter
PROJECTED ACCRUAL There will be 230 patients accrued into this study over 24 years
OUTLINE This is a randomized study Patients are stratified by performance status 0-1 vs 2 and age less than 60 vs at least 60 Patients are randomized to receive methotrexate IV bolus every week for 4 weeks arm I or paclitaxel IV over 1 hour every week for 4 weeks arm II All patients receive at least 4 weeks of treatment 1 course Patients continue treatment for a total of 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years every 6 months for 3 years and annually thereafter
PROJECTED ACCRUAL There will be 230 patients accrued into this study over 24 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 |
|---|---|---|---|
| E-7397 | None | None | None |