Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003380
Status:
TERMINATED
Last Update Posted:
2013-06-10
First Post:
1999-11-01
Brief Title:
Liposomal Doxorubicin and Etoposide in Treating Patients With Recurrent or Persistent Ovarian Fallopian Tube or Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase I Study of Liposomal Doxorubicin Doxil and Prolonged Etoposide As Second Line Therapy in Ovarian Tubal and Peritoneal Carcinoma
Status:
TERMINATED
Status Verified Date:
2002-10
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 combination chemotherapy consisting of liposomal doxorubicin and etoposide in treating patients who have recurrent or persistent ovarian fallopian tube or peritoneal cancer
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin and etoposide in treating patients who have recurrent or persistent ovarian fallopian tube or peritoneal cancer
Detailed Description:
OBJECTIVES I Determine the optimal dose of doxorubicin HCl liposomal and prolonged oral etoposide in patients with recurrent or persistent ovarian tubal and peritoneal carcinoma II Determine the nature and degree of toxicity of this therapy in these patients III Evaluate the response rate of patients with measurable disease
OUTLINE This is a dose escalation multicenter study of etoposide and doxorubicin HCl liposome Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 followed by oral etoposide for 8-14 days beginning on day 2 For patients who achieve partial or complete response treatment repeats every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity For patients with stable disease treatment repeats every 4 weeks for 6 months In the absence of dose limiting toxicity DLT in the first 3 patients treated subsequent cohorts of 3-6 patients each receive doses of etoposide for more prolonged periods After 14 days of oral etoposide the dose of doxorubicin HCl liposome is escalated The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience DLT Patients are followed every 3 months for 1 year then until death
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study within 1 year
OUTLINE This is a dose escalation multicenter study of etoposide and doxorubicin HCl liposome Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 followed by oral etoposide for 8-14 days beginning on day 2 For patients who achieve partial or complete response treatment repeats every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity For patients with stable disease treatment repeats every 4 weeks for 6 months In the absence of dose limiting toxicity DLT in the first 3 patients treated subsequent cohorts of 3-6 patients each receive doses of etoposide for more prolonged periods After 14 days of oral etoposide the dose of doxorubicin HCl liposome is escalated The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience DLT Patients are followed every 3 months for 1 year then until death
PROJECTED ACCRUAL A total of 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 |
|---|---|---|---|
| GOG-9704 | None | None | None |