Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217555
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2005-09-20
Brief Title:
Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian Fallopian Tube or Primary Peritoneal Cavity Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Phase II Trial for the Treatment of Recurrent or Persistent Platinum-Refractory Ovarian Fallopian Tube or Primary Peritoneal Cancer With Gemcitabine and Topotecan
Status:
COMPLETED
Status Verified Date:
2010-09
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 such as gemcitabine and topotecan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving gemcitabine together with topotecan works in treating patients with recurrent or persistent ovarian fallopian tube or primary peritoneal cavity cancer
PURPOSE This phase II trial is studying how well giving gemcitabine together with topotecan works in treating patients with recurrent or persistent ovarian fallopian tube or primary peritoneal cavity cancer
Detailed Description:
OBJECTIVES
Primary
Determine the nature and degree of toxicity of gemcitabine and topotecan in patients with recurrent or persistent platinum-refractory ovarian fallopian tube or primary peritoneal cavity cancer
Determine the response rate in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Secondary
Determine the duration of progression-free survival and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes and topotecan IV over 30 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 additional courses beyond documentation of CR
Quality of life is assessed at baseline on day 1 of courses 2 4 and 6 and then at 1 year
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 36-45 patients will be accrued for this study within 3 years
Primary
Determine the nature and degree of toxicity of gemcitabine and topotecan in patients with recurrent or persistent platinum-refractory ovarian fallopian tube or primary peritoneal cavity cancer
Determine the response rate in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Secondary
Determine the duration of progression-free survival and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes and topotecan IV over 30 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 additional courses beyond documentation of CR
Quality of life is assessed at baseline on day 1 of courses 2 4 and 6 and then at 1 year
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 36-45 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| PSOC-1901 | None | None | None |
| GSK-PSOC-1901 | None | None | None |
| PSOC-IRB-5320 | None | None | None |
| LILLY-PSOC-1901 | None | None | None |
| CDR0000441309 | REGISTRY | PDQ | None |