Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032162
Status:
COMPLETED
Last Update Posted:
2012-05-31
First Post:
2002-03-08
Brief Title:
Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
Sponsor:
AGO Study Group
Organization:
AGO Study Group
Study Overview
Official Title:
Phase III Trial Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin PLD And Carboplatin In Patients With Gynecologic Tumors
Status:
COMPLETED
Status Verified Date:
2012-05
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combining liposomal doxorubicin with carboplatin in treating patients who have gynecologic cancer
PURPOSE Phase III trial to study the effectiveness of combining liposomal doxorubicin with carboplatin in treating patients who have gynecologic cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with carboplatin in patients with gynecological tumors
Determine the dose-limiting toxicity of this regimen in these patients
Determine the kind frequency severity and duration of adverse events in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of doxorubicin HCl liposome
Patients receive doxorubicin HCl liposome IV over 60 minutes followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 28 days for 6 courses
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued and treated at the MTD as above
Patients are followed at 4-6 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 12-24 patients will be accrued for this study within 1 year
Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with carboplatin in patients with gynecological tumors
Determine the dose-limiting toxicity of this regimen in these patients
Determine the kind frequency severity and duration of adverse events in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of doxorubicin HCl liposome
Patients receive doxorubicin HCl liposome IV over 60 minutes followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 28 days for 6 courses
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued and treated at the MTD as above
Patients are followed at 4-6 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 12-24 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| EU-20147 | None | None | None |
| AGOSG-AGO-GYN-2 | None | None | None |