Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040807
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2002-07-08
Brief Title:
Irinotecan and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Trial Of Weekly Irinotecan And Docetaxel In Recurrent Or Metastatic Head And Neck Carcinoma
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 Combining more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of irinotecan and docetaxel in treating patients who have metastatic or locally recurrent head and neck cancer
PURPOSE Phase II trial to study the effectiveness of irinotecan and docetaxel in treating patients who have metastatic or locally recurrent head and neck cancer
Detailed Description:
OBJECTIVES
Determine the response rate in patients with metastatic or locally recurrent head and neck cancer treated with irinotecan and docetaxel
Determine the progression-free and overall survival of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Correlate angiogenesis markers and cyclooxygenase-2 expression with response and survival in patients treated with this regimen
Correlate UGT1A1 genotype with the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy no prior chemotherapy for locally recurrent or metastatic disease or more than 6 months since prior chemotherapy as primary therapy vs 1 prior chemotherapy regimen for locally recurrent or metastatic disease or less than 6 months since prior chemotherapy as primary therapy
Patients receive docetaxel IV over 60 minutes followed by irinotecan IV over 30 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 32-72 patients 16-36 per stratum will be accrued for this study within 6-14 months
Determine the response rate in patients with metastatic or locally recurrent head and neck cancer treated with irinotecan and docetaxel
Determine the progression-free and overall survival of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Correlate angiogenesis markers and cyclooxygenase-2 expression with response and survival in patients treated with this regimen
Correlate UGT1A1 genotype with the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy no prior chemotherapy for locally recurrent or metastatic disease or more than 6 months since prior chemotherapy as primary therapy vs 1 prior chemotherapy regimen for locally recurrent or metastatic disease or less than 6 months since prior chemotherapy as primary therapy
Patients receive docetaxel IV over 60 minutes followed by irinotecan IV over 30 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 32-72 patients 16-36 per stratum will be accrued for this study within 6-14 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| ECOG-E3301 | None | None | None |