Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003334
Status:
COMPLETED
Last Update Posted:
2016-03-11
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Endometrial Cancer Fallopian Tube Cancer or Sarcoma of the Female Reproductive Tract
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Phase II Study of Doxil and Paclitaxel in Patients With Endometrial Tubal and Sarcomas of Gynecologic Origin
Status:
COMPLETED
Status Verified Date:
2016-03
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining doxorubicin and paclitaxel in treating patients who have recurrent or refractory endometrial cancer fallopian tube cancer or sarcoma of the female reproductive tract
PURPOSE Phase II trial to study the effectiveness of combining doxorubicin and paclitaxel in treating patients who have recurrent or refractory endometrial cancer fallopian tube cancer or sarcoma of the female reproductive tract
Detailed Description:
OBJECTIVES I Determine the response rate and duration of response to doxorubicin HCl liposome and paclitaxel in patients with endometrial cancer tubal cancers and sarcomas and carcinosarcomas mixed mesodermal tumors of gynecologic origin II Define the safety profile of the combination of doxorubicin HCl liposome and paclitaxel in this patient population
OUTLINE Patients are stratified into two groups Group 1 consists of patients with untreated endometrial and tubal cancers and Group 2 consists of patients with sarcomas and carcinosarcomas mixed mesodermal tumors of gynecologic origin subdivided into no or prior therapy Patients receive doxorubicin HCl liposome intravenously on day 1 of each treatment course Paclitaxel is administered intravenously weekly on days 1 8 and 15 of each course Courses are repeated every 21 days Treatment continues in the absence of unacceptable toxic effects or disease progression Patients are followed every 3 months for 2 years then every 6 months for 3 years then annually thereafter
PROJECTED ACCRUAL A total of 28-60 patients will be accrued for this study
OUTLINE Patients are stratified into two groups Group 1 consists of patients with untreated endometrial and tubal cancers and Group 2 consists of patients with sarcomas and carcinosarcomas mixed mesodermal tumors of gynecologic origin subdivided into no or prior therapy Patients receive doxorubicin HCl liposome intravenously on day 1 of each treatment course Paclitaxel is administered intravenously weekly on days 1 8 and 15 of each course Courses are repeated every 21 days Treatment continues in the absence of unacceptable toxic effects or disease progression Patients are followed every 3 months for 2 years then every 6 months for 3 years then annually thereafter
PROJECTED ACCRUAL A total of 28-60 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 |
|---|---|---|---|
| NCI-G98-1427 | None | None | None |
| NYU-9708 | None | None | None |
| NYGOG-NY9708 | None | None | None |