Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055614
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2003-03-06
Brief Title:
Topotecan in Treating Patients With Advanced Ovarian Epithelial Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Oral Topotecan as Consolidation for Patients With Mullerian Origin Tumors Ovary Tube Peritoneum
Status:
COMPLETED
Status Verified Date:
2007-04
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 I trial to study the effectiveness of topotecan in treating patients who have advanced ovarian epithelial fallopian tube or primary peritoneal cancer
PURPOSE Phase I trial to study the effectiveness of topotecan in treating patients who have advanced ovarian epithelial fallopian tube or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and duration of prolonged topotecan as maintenance in patients with advanced ovarian epithelial fallopian tube or primary peritoneal cancer with complete clinical response after platinum-based chemotherapy
Determine the safety of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive oral topotecan twice daily for 21 days Treatment repeats every 28 days for up to 6 months in the absence of unacceptable toxicity or disease progression
Patients who tolerate course 1 may receive an escalated dose of topotecan for subsequent courses The maximum tolerated dose is defined as the dose tolerated by the majority of the patients
Patients are followed every 2 months for at least 6 months
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Determine the maximum tolerated dose and duration of prolonged topotecan as maintenance in patients with advanced ovarian epithelial fallopian tube or primary peritoneal cancer with complete clinical response after platinum-based chemotherapy
Determine the safety of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive oral topotecan twice daily for 21 days Treatment repeats every 28 days for up to 6 months in the absence of unacceptable toxicity or disease progression
Patients who tolerate course 1 may receive an escalated dose of topotecan for subsequent courses The maximum tolerated dose is defined as the dose tolerated by the majority of the patients
Patients are followed every 2 months for at least 6 months
PROJECTED ACCRUAL A total of 20 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 |
|---|---|---|---|
| CDR0000269138 | REGISTRY | None | None |
| NEDH-E-010405FB | Registry Identifier | PDQ Physician Data Query | None |