Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114218
Status:
COMPLETED
Last Update Posted:
2019-01-08
First Post:
2005-06-13
Brief Title:
Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation of Gemcitabine NSC 613327 and Docetaxel NSC 628503 in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus
Status:
COMPLETED
Status Verified Date:
2014-12
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:
This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent or persistent uterine cancer Drugs used in chemotherapy such as gemcitabine and docetaxel 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
Detailed Description:
OBJECTIVES
I Determine the antitumor activity of gemcitabine and docetaxel in patients with recurrent or persistent uterine carcinosarcoma
II Determine the nature and degree of toxicity of this regimen in these patients
OUTLINE This is a non-randomized multicenter study Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1 8 and 15 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 22-60 patients will be accrued for this study within 1-4 years
I Determine the antitumor activity of gemcitabine and docetaxel in patients with recurrent or persistent uterine carcinosarcoma
II Determine the nature and degree of toxicity of this regimen in these patients
OUTLINE This is a non-randomized multicenter study Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1 8 and 15 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 22-60 patients will be accrued for this study within 1-4 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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-02680 | REGISTRY | None | None |
| CDR0000434843 | None | None | None |
| GOG-0130E | OTHER | None | None |
| GOG-0130E | OTHER | None | None |