Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337129
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2006-06-13
Brief Title:
S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Evaluation of E7389 NSC-707389 in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
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 such as E7389 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well E7389 works in treating patients with metastatic or recurrent head and neck cancer
PURPOSE This phase II trial is studying how well E7389 works in treating patients with metastatic or recurrent head and neck cancer
Detailed Description:
OBJECTIVES
Evaluate the response probability confirmed complete and partial responses in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with E7389
Estimate progression-free and overall survival probability in these patients
Evaluate the qualitative and quantitative toxicities of this treatment regimen
OUTLINE This is a multicenter study
Patients receive E7389 IV on days 1 and 8 Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression
After completion of study treatment patients are followed periodically for up to 3 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Evaluate the response probability confirmed complete and partial responses in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with E7389
Estimate progression-free and overall survival probability in these patients
Evaluate the qualitative and quantitative toxicities of this treatment regimen
OUTLINE This is a multicenter study
Patients receive E7389 IV on days 1 and 8 Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression
After completion of study treatment patients are followed periodically for up to 3 years
PROJECTED ACCRUAL A total of 40 patients 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 |
|---|---|---|---|
| CDR0000481530 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| U10CA032102 | NIH | None | None |
| S0618 | OTHER | None | None |