Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052312
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2003-01-24
Brief Title:
Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced Metastatic andor Relapsed Endometrial Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Trial Of Adriamycin A Cisplatin P Chemotherapy Versus Paclitaxel T Adriamycin A And Cisplatin P In Patients With MetastaticRelapsed Or Locally Advanced Inoperable Endometrial Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
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 work in different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells It is not yet known whether doxorubicin and cisplatin are more effective with or without paclitaxel in treating endometrial cancer
PURPOSE Randomized phase II trial to compare the effectiveness of combining doxorubicin and cisplatin with or without paclitaxel in treating patients who have locally advanced metastatic andor relapsed endometrial cancer
PURPOSE Randomized phase II trial to compare the effectiveness of combining doxorubicin and cisplatin with or without paclitaxel in treating patients who have locally advanced metastatic andor relapsed endometrial cancer
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with locally advanced metastatic andor relapsed endometrial cancer treated with doxorubicin and cisplatin with or without paclitaxel
Compare the toxicity of these regimens in these patients
Compare the progression-free survival at 18 months of patients treated with these regimens
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to performance status 0 vs 1 vs 2 metastatic disease M0 vs M1 prior pelvic radiotherapy for pelvic recurrence yes vs no and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive doxorubicin IV over 30 minutes paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive doxorubicin and cisplatin as in arm I Quality of life is assessed at baseline before each course after courses 3 and 6 every 3 months for 2 years every 6 months for 3 years and then annually thereafter In the event of progressive disease quality of life is assessed every 3 months
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter In the event of progressive disease patients are followed every 3 months
PROJECTED ACCRUAL A total of 140 patients will be accrued for this study
Compare the overall survival of patients with locally advanced metastatic andor relapsed endometrial cancer treated with doxorubicin and cisplatin with or without paclitaxel
Compare the toxicity of these regimens in these patients
Compare the progression-free survival at 18 months of patients treated with these regimens
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to performance status 0 vs 1 vs 2 metastatic disease M0 vs M1 prior pelvic radiotherapy for pelvic recurrence yes vs no and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive doxorubicin IV over 30 minutes paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive doxorubicin and cisplatin as in arm I Quality of life is assessed at baseline before each course after courses 3 and 6 every 3 months for 2 years every 6 months for 3 years and then annually thereafter In the event of progressive disease quality of life is assessed every 3 months
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter In the event of progressive disease patients are followed every 3 months
PROJECTED ACCRUAL A total of 140 patients 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 |
|---|---|---|---|
| EORTC-55984 | None | None | None |