Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004066
Status:
COMPLETED
Last Update Posted:
2013-03-07
First Post:
1999-12-10
Brief Title:
Gemcitabine Docetaxel and Filgrastim in Treating Patients With Recurrent or Persistent Leiomyosarcoma or Soft Tissue Sarcoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable Leiomyosarcoma
Status:
COMPLETED
Status Verified Date:
2013-03
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 Colony-stimulating factors such as filgrastim 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
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine docetaxel and filgrastim in treating patients who have recurrent or persistent leiomyosarcoma or soft tissue sarcoma that cannot be removed by surgery
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine docetaxel and filgrastim in treating patients who have recurrent or persistent leiomyosarcoma or soft tissue sarcoma that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Evaluate the activity of gemcitabine plus docetaxel administered with filgrastim G-CSF support in terms of disease response in patients with recurrent or persistent unresectable leiomyosarcoma or other soft tissue sarcoma
Determine the tolerability of this regimen in these patients
Correlate response with tumor expression of the apoptosis-regulating proteins bax bcl-2 and survivin in these patients
OUTLINE Patients are stratified according to prior radiotherapy to the pelvis yes vs no
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by docetaxel IV over 1 hour on day 8 and filgrastim G-CSF subcutaneously on days 9-15 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients with a partial response may receive 2 additional courses of therapy
Patients are followed every 3 months for 1 year or until disease progression
PROJECTED ACCRUAL A total of 38-82 patients 19-43 with uterine leiomyosarcoma and 19-39 with other soft tissue sarcoma will be accrued for this study
Evaluate the activity of gemcitabine plus docetaxel administered with filgrastim G-CSF support in terms of disease response in patients with recurrent or persistent unresectable leiomyosarcoma or other soft tissue sarcoma
Determine the tolerability of this regimen in these patients
Correlate response with tumor expression of the apoptosis-regulating proteins bax bcl-2 and survivin in these patients
OUTLINE Patients are stratified according to prior radiotherapy to the pelvis yes vs no
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by docetaxel IV over 1 hour on day 8 and filgrastim G-CSF subcutaneously on days 9-15 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients with a partial response may receive 2 additional courses of therapy
Patients are followed every 3 months for 1 year or until disease progression
PROJECTED ACCRUAL A total of 38-82 patients 19-43 with uterine leiomyosarcoma and 19-39 with other soft tissue sarcoma 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 |
|---|---|---|---|
| NCI-G99-1576 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |
| MSKCC-99027 | None | None | None |