Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022594
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
2001-08-10
Brief Title:
Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Study Of NX 211 Liposomal Lurtotecan Given As An IV Bolus Injection On Days 1 and 8 Every 3 Weeks In Patients With Metastatic Or Loco-Regional Recurrent Squamous Cell Carcinoma Of The Head and Neck With Target Lesions Within Previously Irradiated Fields Or Outside Previously Irradiated Fields
Status:
COMPLETED
Status Verified Date:
2012-07
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 liposomal lurtotecan in treating patients who have metastatic or locally recurrent head and neck cancer
PURPOSE Phase II trial to study the effectiveness of liposomal lurtotecan in treating patients who have metastatic or locally recurrent head and neck cancer
Detailed Description:
OBJECTIVES
Determine the therapeutic activity of lurtotecan liposome in patients with metastatic or loco-regionally recurrent squamous cell carcinoma of the head and neck
Determine the objective response duration of response and time to progression in patients treated with this drug
Determine the toxicity profile of this drug in these patients
Determine the possible pharmacokineticpharmacodynamic relationship of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to presence of a target lesion in a previously irradiated field within vs outside
Patients receive lurtotecan liposome IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 weeks
PROJECTED ACCRUAL A total of 38-72 patients 19-36 per stratum will be accrued for this study
Determine the therapeutic activity of lurtotecan liposome in patients with metastatic or loco-regionally recurrent squamous cell carcinoma of the head and neck
Determine the objective response duration of response and time to progression in patients treated with this drug
Determine the toxicity profile of this drug in these patients
Determine the possible pharmacokineticpharmacodynamic relationship of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to presence of a target lesion in a previously irradiated field within vs outside
Patients receive lurtotecan liposome IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 weeks
PROJECTED ACCRUAL A total of 38-72 patients 19-36 per stratum will be accrued for this study
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 |
|---|---|---|---|
| EORTC-16008 | None | None | None |
| GILEAD-110-10 | None | None | None |
| OSI-EORTC-16008 | None | None | None |