Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030472
Status:
TERMINATED
Last Update Posted:
2013-04-11
First Post:
2002-02-14
Brief Title:
Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation of Liposomal Doxorubicin Doxil in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
Status:
TERMINATED
Status Verified Date:
2004-09
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 liposomal doxorubicin in treating patients who have persistent or recurrent cancer of the cervix
PURPOSE Phase II trial to study the effectiveness liposomal doxorubicin in treating patients who have persistent or recurrent cancer of the cervix
Detailed Description:
OBJECTIVES
Determine the antitumor activity of doxorubicin HCl liposome in patients with persistent or recurrent squamous cell carcinoma of the cervix
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 Treatment repeats every 28 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 22-60 patients will be accrued for this study
Determine the antitumor activity of doxorubicin HCl liposome in patients with persistent or recurrent squamous cell carcinoma of the cervix
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 Treatment repeats every 28 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 22-60 patients will be accrued for this study
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-0127R | None | None | None |