Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016926
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2001-06-06
Brief Title:
Capecitabine 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 Capecitabine In Advanced Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
Status:
COMPLETED
Status Verified Date:
2004-05
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 capecitabine in treating patients who have advanced persistent or recurrent cervical cancer
PURPOSE Phase II trial to study the effectiveness of capecitabine in treating patients who have advanced persistent or recurrent cervical cancer
Detailed Description:
OBJECTIVES
Determine the activity of capecitabine in patients with advanced persistent or recurrent squamous cell carcinoma of the cervix
Determine the toxicity profile of this drug in this patient population
OUTLINE This is a multicenter study
Patients receive oral capecitabine twice daily on days 1-14 Courses repeat every 21 days 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 A total of 28-62 patients will be accrued for this study within 9-20 months
Determine the activity of capecitabine in patients with advanced persistent or recurrent squamous cell carcinoma of the cervix
Determine the toxicity profile of this drug in this patient population
OUTLINE This is a multicenter study
Patients receive oral capecitabine twice daily on days 1-14 Courses repeat every 21 days 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 A total of 28-62 patients will be accrued for this study within 9-20 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-0076CC | None | None | None |