Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101192
Status:
COMPLETED
Last Update Posted:
2014-03-17
First Post:
2005-01-07
Brief Title:
Cetuximab and Cisplatin in Treating Patients With Advanced Persistent or Recurrent Cervical Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Limited Access Phase II Trial of Cetuximab C225 NSC 714692 in Combination With Cisplatin NSC 119875 in the Treatment of Advanced Persistent or Recurrent Carcinoma of the Cervix
Status:
COMPLETED
Status Verified Date:
2014-02
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 Monoclonal antibodies such as cetuximab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Cetuximab may also help cisplatin work better by making tumor cells more sensitive to the drug Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving cetuximab together with cisplatin may be a better way to block tumor growth
PURPOSE This phase II trial is studying how well giving cetuximab together with cisplatin works in treating patients with advanced persistent or recurrent cervical cancer
PURPOSE This phase II trial is studying how well giving cetuximab together with cisplatin works in treating patients with advanced persistent or recurrent cervical cancer
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of cetuximab and cisplatin in terms of objective tumor response partial and complete in patients with advanced persistent or recurrent carcinoma of the cervix
Determine the nature and degree of toxicity of this regimen in these patients
Secondary
Determine the progression-free survival and overall survival of patients treated with this regimen
Correlate epidermal growth factor receptor expression with progression-free survival overall survival and response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive cetuximab IV over 1-2 hours on days 1 8 and 15 and cisplatin IV on days 1 and 8 Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 28-62 patients will be accrued for this study within 9-20 months
Primary
Determine the antitumor activity of cetuximab and cisplatin in terms of objective tumor response partial and complete in patients with advanced persistent or recurrent carcinoma of the cervix
Determine the nature and degree of toxicity of this regimen in these patients
Secondary
Determine the progression-free survival and overall survival of patients treated with this regimen
Correlate epidermal growth factor receptor expression with progression-free survival overall survival and response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive cetuximab IV over 1-2 hours on days 1 8 and 15 and cisplatin IV on days 1 and 8 Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 28-62 patients will be accrued for this study within 9-20 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 |
|---|---|---|---|
| BMS-CA225-075 | None | None | None |
| CDR0000405839 | None | None | None |