Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026260
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-11-09
Brief Title:
SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation of SU5416 NSC 696819 in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
Status:
COMPLETED
Status Verified Date:
2007-06
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 Biological therapy with drugs such as SU5416 may stop the growth of cervical cancer by stopping blood flow to the tumor
PURPOSE Phase II trial to study the effectiveness of SU5416 in treating patients who have persistent or recurrent cervical cancer
PURPOSE Phase II trial to study the effectiveness of SU5416 in treating patients who have persistent or recurrent cervical cancer
Detailed Description:
OBJECTIVES
Determine the antitumor cytostatic activity of SU5416 in terms of 6-month progression-free survival and time to progression in patients with persistent or recurrent cervical squamous cell carcinoma
Determine the nature and degree of toxicity of this drug in these patients
Correlate surrogate endpoint molecular and imaging markers with clinical outcome in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive SU5416 IV over 1 hour on days 1 and 4 Treatment repeats weekly in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 19-51 patients will be accrued for this study within 8-23 months
Determine the antitumor cytostatic activity of SU5416 in terms of 6-month progression-free survival and time to progression in patients with persistent or recurrent cervical squamous cell carcinoma
Determine the nature and degree of toxicity of this drug in these patients
Correlate surrogate endpoint molecular and imaging markers with clinical outcome in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive SU5416 IV over 1 hour on days 1 and 4 Treatment repeats weekly in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 19-51 patients will be accrued for this study within 8-23 months
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 |
|---|---|---|---|
| GOG-0227B | None | None | None |