Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389974
Status:
COMPLETED
Last Update Posted:
2015-02-16
First Post:
2006-10-18
Brief Title:
Sunitinib Malate in Treating Patients With Uterine Cervical Cancer That is Stage IVB Recurrent or Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Sunitinib SU11248 NSC 736511 an Oral Multi-Targeted Tyrosine Kinase Inhibitor in Patients With Unresectable Locally Advanced or Metastatic Cervical Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-03
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:
This phase II trial studies the side effects and how well sunitinib malate works in treating patients with cervical cancer which cannot be cured by standard therapy Sunitinib malate may stop the growth of cervical cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I To assess the efficacy objective response rate of sunitinib sunitinib malate given orally daily for 4 out of every 6 weeks in patients with unresectable locally advanced or metastatic carcinoma of the cervix
II To assess the toxicity of sunitinib in patients with unresectable locally advanced or metastatic carcinoma of the cervix
III To document time to progression early objective progression rate and if objective responses are observed response duration
OUTLINE
Patients receive sunitinib malate orally PO daily for 4 weeks Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR or partial response PR may receive 2 courses after CR or PR is reached
After completion of study treatment patients are followed up at 4 weeks and then every 3 months thereafter
I To assess the efficacy objective response rate of sunitinib sunitinib malate given orally daily for 4 out of every 6 weeks in patients with unresectable locally advanced or metastatic carcinoma of the cervix
II To assess the toxicity of sunitinib in patients with unresectable locally advanced or metastatic carcinoma of the cervix
III To document time to progression early objective progression rate and if objective responses are observed response duration
OUTLINE
Patients receive sunitinib malate orally PO daily for 4 weeks Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR or partial response PR may receive 2 courses after CR or PR is reached
After completion of study treatment patients are followed up at 4 weeks and then every 3 months thereafter
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 |
|---|---|---|---|
| NCIC-184 | OTHER | CTEP | None |
| NCI-2014-00648 | REGISTRY | None | None |
| NCIC CTG IND184 | None | None | None |
| IND184 | None | None | None |
| NCIC-184 | OTHER | None | None |