Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002922
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
1999-11-01
Brief Title:
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 II Evaluation of Paclitaxel Infusion in Advanced Recurrent or Metastatic 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
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or metastatic head and neck cancer
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or metastatic head and neck cancer
Detailed Description:
OBJECTIVES I Evaluate the response rate and toxic effects of paclitaxel by 96 hour continuous infusion in chemotherapy naive and chemotherapy exposed patients with recurrent or metastatic squamous cell carcinoma of the head and neck
OUTLINE Patients receive paclitaxel as a 96 hour continuous IV infusion Courses repeat every 3 weeks for a maximum of 12 courses Patients with disease progression after 2 courses or with unacceptable toxicity at any time are removed from study
PROJECTED ACCRUAL Approximately 109 patients will be accrued for this study over 4 years
OUTLINE Patients receive paclitaxel as a 96 hour continuous IV infusion Courses repeat every 3 weeks for a maximum of 12 courses Patients with disease progression after 2 courses or with unacceptable toxicity at any time are removed from study
PROJECTED ACCRUAL Approximately 109 patients will be accrued for this study over 4 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-3395 | None | None | None |