Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002993
Status:
TERMINATED
Last Update Posted:
2013-07-09
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Recurrent or Advanced Cancer of the Uterus
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Evaluation of Mitomycin Doxorubicin and Cisplatin in the Treatment of Recurrent or Advanced Uterine Sarcomas
Status:
TERMINATED
Status Verified Date:
2006-05
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 combination chemotherapy with mitomycin doxorubicin and cisplatin in treating patients with recurrent or advanced cancer of the uterus
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with mitomycin doxorubicin and cisplatin in treating patients with recurrent or advanced cancer of the uterus
Detailed Description:
OBJECTIVES I Estimate the antitumor activity of the combination of mitomycin doxorubicin and cisplatin MAP in patients with recurrent or advanced uterine sarcomas II Determine the nature and degree of toxicity of MAP chemotherapy in this cohort of patients
OUTLINE Patients receive IV doxorubicin mitomycin and cisplatin over 3 hours once every 3 weeks for a minimum of 1 course Patients who have complete response partial response or stable disease will continue for at least 3 courses If side effects are not severe patients may remain on the study regimen at the investigators discretion for a maximum of 6 courses All patients are followed until death
PROJECTED ACCRUAL The first stage of accrual is anticipated to accrue 20 evaluable patients in approximately 12 months If indicated a second stage will accrue approximately 10 evaluable patients
OUTLINE Patients receive IV doxorubicin mitomycin and cisplatin over 3 hours once every 3 weeks for a minimum of 1 course Patients who have complete response partial response or stable disease will continue for at least 3 courses If side effects are not severe patients may remain on the study regimen at the investigators discretion for a maximum of 6 courses All patients are followed until death
PROJECTED ACCRUAL The first stage of accrual is anticipated to accrue 20 evaluable patients in approximately 12 months If indicated a second stage will accrue approximately 10 evaluable patients
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 |
|---|---|---|---|
| GOG-87I | None | None | None |