Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003967
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
1999-11-01
Brief Title:
Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian Peritoneal or Fallopian Tube Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase I Study of Sequential Prolonged Oral Topotecan IND 58131 and Prolonged Oral Etoposide as Second Line Therapy in Ovarian Peritoneal or Tubal Carcinoma
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 I trial to study the effectiveness of topotecan plus etoposide in treating patients who have recurrent ovarian cancer peritoneal cancer or fallopian tube cancer
PURPOSE Phase I trial to study the effectiveness of topotecan plus etoposide in treating patients who have recurrent ovarian cancer peritoneal cancer or fallopian tube cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of sequential prolonged topotecan and prolonged etoposide as second line therapy in patients with recurrent ovarian epithelial peritoneal or tubal cancer II Determine the nature and degree of toxicity of this treatment regimen in this patient population III Evaluate the response rate and time to disease progression in these patients
OUTLINE This is a dose escalation study Patients receive oral topotecan daily on days 1-5 and oral etoposide daily on days 8-10 Courses repeat every 28 days in the absence of disease progression or unacceptable side effects Patients achieving partial or complete response or stable disease continue treatment for at least 4-6 courses Cohorts of 3-6 patients receive topotecan and etoposide on increasing numbers of days until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no greater than 1 of 6 patients experiences dose limiting toxicity Patients are followed every 3 months or until death
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study within 12 months
OUTLINE This is a dose escalation study Patients receive oral topotecan daily on days 1-5 and oral etoposide daily on days 8-10 Courses repeat every 28 days in the absence of disease progression or unacceptable side effects Patients achieving partial or complete response or stable disease continue treatment for at least 4-6 courses Cohorts of 3-6 patients receive topotecan and etoposide on increasing numbers of days until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no greater than 1 of 6 patients experiences dose limiting toxicity Patients are followed every 3 months or until death
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study within 12 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-9807 | None | None | None |