Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101127
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
2005-01-07
Brief Title:
Docetaxel Gemcitabine and Filgrastim G-CSF or Pegfilgrastim in Treating Patients With Advanced Persistent or Recurrent Uterine Leiomyosarcoma
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation of Docetaxel NSC 628503 and Gemcitabine NSC 613327 Plus G-CSF in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus
Status:
COMPLETED
Status Verified Date:
2014-02
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 such as docetaxel and gemcitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Colony-stimulating factors such as G-CSF and pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy Giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim may kill more tumor cells
PURPOSE This phase II trial is studying how well giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim works in treating patients with advanced persistent or recurrent uterine leiomyosarcoma
PURPOSE This phase II trial is studying how well giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim works in treating patients with advanced persistent or recurrent uterine leiomyosarcoma
Detailed Description:
OBJECTIVES
Determine the antitumor activity of docetaxel gemcitabine and filgrastim G-CSF or pegfilgrastim in patients with advanced persistent or recurrent uterine leiomyosarcoma
Determine the nature and degree of toxicity of this regimen in these patients
OUTLINE This is a multicenter study Patients are stratified according to prior pelvic radiotherapy yes vs no
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8 Patients also receive filgrastim G-CSF subcutaneously SC on days 9-15 OR pegfilgrastim SC on day 9 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 12-43 patients will be accrued for this study within 12-28 months
Determine the antitumor activity of docetaxel gemcitabine and filgrastim G-CSF or pegfilgrastim in patients with advanced persistent or recurrent uterine leiomyosarcoma
Determine the nature and degree of toxicity of this regimen in these patients
OUTLINE This is a multicenter study Patients are stratified according to prior pelvic radiotherapy yes vs no
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8 Patients also receive filgrastim G-CSF subcutaneously SC on days 9-15 OR pegfilgrastim SC on day 9 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 12-43 patients will be accrued for this study within 12-28 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 |
|---|---|---|---|
| CDR0000405892 | None | None | None |