Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063999
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2003-07-08
Brief Title:
Doxorubicin Hydrochloride Cisplatin and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer
Sponsor:
GOG Foundation
Organization:
GOG Foundation
Study Overview
Official Title:
Randomized Phase III Trial of DoxorubicinCisplatinPaclitaxel and G-CSF Versus CarboplatinPaclitaxel in Patients With Stage III Amp IV or Recurrent Endometrial Cancer
Status:
COMPLETED
Status Verified Date:
2021-09
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:
This randomized phase III trial compares how well two different combination chemotherapy regimens doxorubicin hydrochloride cisplatin and paclitaxel versus carboplatin and paclitaxel work in treating patients with endometrial cancer that is stage III-IV or has come back recurrent Drugs used in chemotherapy such as doxorubicin hydrochloride cisplatin paclitaxel and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading It is not yet known which combination chemotherapy regimen is more effective in treating endometrial cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine if the combination of carboplatin and paclitaxel TC chemotherapy is therapeutically equivalent to the combination of doxorubicin doxorubicin hydrochloride cisplatin and paclitaxel TAP chemotherapy with regards to survival
II To determine if estrogenprogesterone receptor status provides prognostic information in patients treated with chemotherapy
III To assess whether combination TC chemotherapy is superior to combination TAP chemotherapy with regards to toxicity profile specifically neurotoxicity and infection
IV To measure differences in patient-reported neurotoxicity and quality of life QOL among the regimens
OUTLINE Patients are randomized to 1 of 2 treatment arms Patients with left ventricular ejection fraction 50 at randomization who are initially randomized to Arm I are immediately crossed over to Arm II
ARM I Patients receive doxorubicin hydrochloride intravenously IV over approximately 15-30 minutes on day 1 cisplatin IV over 60-90 minutes on day 1 paclitaxel IV over 3 hours on day 2 and filgrastim subcutaneously SC on days 3-12 or pegfilgrastim SC on day 3
ARM II Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1
In both arms treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I To determine if the combination of carboplatin and paclitaxel TC chemotherapy is therapeutically equivalent to the combination of doxorubicin doxorubicin hydrochloride cisplatin and paclitaxel TAP chemotherapy with regards to survival
II To determine if estrogenprogesterone receptor status provides prognostic information in patients treated with chemotherapy
III To assess whether combination TC chemotherapy is superior to combination TAP chemotherapy with regards to toxicity profile specifically neurotoxicity and infection
IV To measure differences in patient-reported neurotoxicity and quality of life QOL among the regimens
OUTLINE Patients are randomized to 1 of 2 treatment arms Patients with left ventricular ejection fraction 50 at randomization who are initially randomized to Arm I are immediately crossed over to Arm II
ARM I Patients receive doxorubicin hydrochloride intravenously IV over approximately 15-30 minutes on day 1 cisplatin IV over 60-90 minutes on day 1 paclitaxel IV over 3 hours on day 2 and filgrastim subcutaneously SC on days 3-12 or pegfilgrastim SC on day 3
ARM II Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1
In both arms treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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-2009-00584 | REGISTRY | None | None |
| CDR0000305940 | None | None | None |
| GOG-0209 | OTHER | None | None |
| GOG-0209 | OTHER | None | None |
| U10CA180868 | NIH | None | None |