Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031629
Status:
COMPLETED
Last Update Posted:
2016-12-08
First Post:
2002-03-08
Brief Title:
Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation of Docetaxel and Gemcitabine Plus G-CSF in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
Status:
COMPLETED
Status Verified Date:
2016-12
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:
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 Colony-stimulating factors such as filgrastim or pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy This phase II trial is studying how well combination chemotherapy plus filgrastim or pegfilgrastim works in treating patients with recurrent or persistent cancer of the uterus
Detailed Description:
PRIMARY OBJECTIVES
I Determine the antitumor activity of docetaxel gemcitabine and filgrastim G-CSF or pegfilgrastim in patients with persistent or recurrent uterine leiomyosarcoma
II Determine the nature and degree of toxicity of this regimen in these patients
OUTLINE
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 docetaxel IV over 1 hour on day 8 and filgrastim G-CSF subcutaneously SC on days 9-15 or pegfilgrastim SC on day 9 only Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 19-51 patients will be accrued for this study within 10-24 months
I Determine the antitumor activity of docetaxel gemcitabine and filgrastim G-CSF or pegfilgrastim in patients with persistent or recurrent uterine leiomyosarcoma
II Determine the nature and degree of toxicity of this regimen in these patients
OUTLINE
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 docetaxel IV over 1 hour on day 8 and filgrastim G-CSF subcutaneously SC on days 9-15 or pegfilgrastim SC on day 9 only Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 19-51 patients will be accrued for this study within 10-24 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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-02456 | REGISTRY | None | None |
| CDR0000069206 | None | None | None |
| GOG-0131G | OTHER | None | None |
| GOG-0131G | OTHER | None | None |