Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006235
Status:
COMPLETED
Last Update Posted:
2013-07-09
First Post:
2000-09-11
Brief Title:
Liposomal Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase I Trial of Combination Carboplatin and Lipsomal Doxorubicin Doxil In Recurrent Ovarian Fallopian Tube or Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2006-02
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 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 I trial to study the effectiveness of combining liposomal doxorubicin and carboplatin in treating patients who have recurrent ovarian fallopian tube or primary peritoneal cancer
PURPOSE Phase I trial to study the effectiveness of combining liposomal doxorubicin and carboplatin in treating patients who have recurrent ovarian fallopian tube or primary peritoneal cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of doxorubicin HCl liposome Doxil when combined with carboplatin in patients with recurrent ovarian fallopian tube or primary peritoneal cancer II Determine the toxicity of this regimen in these patients III Determine the rate of response in patients treated with this regimen
OUTLINE This is a dose escalation multicenter study of doxorubicin HCl liposome Doxil Patients receive Doxil IV over 1 hour and carboplatin IV on day 1 Treatment continues every 4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of Doxil until the maximum tolerated dose MTD is determined The MTD is defined as the highest dose at which 0 or 1 of 6 patients experience dose limiting toxicity Patients are followed every 3 months for 2 years then every 6 months for 3 years and then annually thereafter until recurrence or death
PROJECTED ACCRUAL Approximately 24 patients will be accrued for this study over 1 year
OUTLINE This is a dose escalation multicenter study of doxorubicin HCl liposome Doxil Patients receive Doxil IV over 1 hour and carboplatin IV on day 1 Treatment continues every 4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of Doxil until the maximum tolerated dose MTD is determined The MTD is defined as the highest dose at which 0 or 1 of 6 patients experience dose limiting toxicity Patients are followed every 3 months for 2 years then every 6 months for 3 years and then annually thereafter until recurrence or death
PROJECTED ACCRUAL Approximately 24 patients will be accrued for this study over 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 |
|---|---|---|---|
| GOG-9909 | None | None | None |