Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227669
Status:
COMPLETED
Last Update Posted:
2016-08-30
First Post:
2005-09-26
Brief Title:
Gemcitabine With or Without Docetaxel as Second-Line Therapy in Treating Patients With Metastatic or Relapsed Unresectable Uterine or Soft Tissue Leiomyosarcoma
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Randomized Phase II Study Evaluating the Efficacy of Gemcitabine Versus the GemcitabineDocetaxel Combination as Second Line Treatment in Metastatic or Relapsed and Inoperable Uterine or Soft Tissue Leiomyosarcomas
Status:
COMPLETED
Status Verified Date:
2016-08
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 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 It is not yet known whether giving gemcitabine together with docetaxel is more effective than giving gemcitabine alone as second-line therapy in treating uterine or soft tissue leiomyosarcoma
PURPOSE This randomized phase II trial is studying gemcitabine and docetaxel to see how well they work compared to gemcitabine alone as second-line therapy in treating patients with metastatic or relapsed unresectable uterine or soft tissue leiomyosarcoma
PURPOSE This randomized phase II trial is studying gemcitabine and docetaxel to see how well they work compared to gemcitabine alone as second-line therapy in treating patients with metastatic or relapsed unresectable uterine or soft tissue leiomyosarcoma
Detailed Description:
OBJECTIVES
Primary
Compare the anti-tumor activity in terms of objective response rate in patients with metastatic or relapsed unresectable uterine or soft tissue leiomyosarcoma treated with gemcitabine with vs without docetaxel as second-line therapy
Secondary
Compare the progression-free survival of patients treated with these regimens
Compare the response duration and overall survival of patients treated with these regimens
Compare the tolerability and dose intensity of these regimens in these patients
Determine biological markers with a predictive value for response to these regimens in these patients
OUTLINE This is a randomized study Patients are stratified according to location of leiomyosarcoma uterine vs soft tissue Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine on days 1 8 and 15 Treatment repeats every 4 weeks for 2-8 courses
Arm II Patients receive gemcitabine on days 1 and 8 and docetaxel on day 8 Treatment repeats every 3 weeks for 2-8 courses
PROJECTED ACCRUAL A minimum of 80 patients 40 per stratum and treatment arm will be accrued for this study
Primary
Compare the anti-tumor activity in terms of objective response rate in patients with metastatic or relapsed unresectable uterine or soft tissue leiomyosarcoma treated with gemcitabine with vs without docetaxel as second-line therapy
Secondary
Compare the progression-free survival of patients treated with these regimens
Compare the response duration and overall survival of patients treated with these regimens
Compare the tolerability and dose intensity of these regimens in these patients
Determine biological markers with a predictive value for response to these regimens in these patients
OUTLINE This is a randomized study Patients are stratified according to location of leiomyosarcoma uterine vs soft tissue Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine on days 1 8 and 15 Treatment repeats every 4 weeks for 2-8 courses
Arm II Patients receive gemcitabine on days 1 and 8 and docetaxel on day 8 Treatment repeats every 3 weeks for 2-8 courses
PROJECTED ACCRUAL A minimum of 80 patients 40 per stratum and treatment arm will be accrued for this study
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 |
|---|---|---|---|
| FRE-FNCLCC-SARCOME-070410 | None | None | None |
| EU-20518 | None | None | None |