Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002813
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Recurrent or Refractory Cervical Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A LIMITED ACCESS PHASE II TRIAL OF CISPLATIN AND NAVELBINE VINORELBINE IN ADVANCED AND RECURRENT SQUAMOUS CELL CARCINOMA OF THE CERVIX
Status:
COMPLETED
Status Verified Date:
2008-03
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with cisplatin and vinorelbine in treating patients with refractory or recurrent squamous cell cervical cancer that has not responded to local therapy
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with cisplatin and vinorelbine in treating patients with refractory or recurrent squamous cell cervical cancer that has not responded to local therapy
Detailed Description:
OBJECTIVES I Determine the activity of cisplatin and vinorelbine in terms of response rate duration of response time to treatment failure and survival in patients with advanced persistent or recurrent squamous cell carcinoma of the cervix
OUTLINE This is a multicenter study Patients receive vinorelbine IV over 6-10 minutes on days 1 8 15 and 22 and cisplatin IV over 4 hours beginning after completion of vinorelbine infusion on day 1 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity 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 approximately 20 months
OUTLINE This is a multicenter study Patients receive vinorelbine IV over 6-10 minutes on days 1 8 15 and 22 and cisplatin IV over 4 hours beginning after completion of vinorelbine infusion on day 1 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity 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 approximately 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 |
|---|---|---|---|
| GOG-76Z | None | None | None |