Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033644
Status:
TERMINATED
Last Update Posted:
2013-04-11
First Post:
2002-04-09
Brief Title:
Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced Persistent or Recurrent Leiomyosarcoma of the Uterus
Status:
TERMINATED
Status Verified Date:
2004-09
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 use different ways to stop tumor cells from dividing so they stop growing or die Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus sargramostim in treating patients who have advanced persistent or recurrent cancer of the uterus
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus sargramostim in treating patients who have advanced persistent or recurrent cancer of the uterus
Detailed Description:
OBJECTIVES
Determine the antitumor activity of dacarbazine mitomycin doxorubicin and cisplatin plus sargramostim GM-CSF in patients with advanced persistent or recurrent leiomyosarcoma of the uterus
Determine the nature and degree of toxicity of this regimen in these patients
OUTLINE Patients receive dacarbazine IV over 2 hours followed by mitomycin IV over 2-5 minutes doxorubicin IV over 2-5 minutes and cisplatin IV over 2 hours on day 1 Patients also receive sargramostim GM-CSF subcutaneously SC once every 12 hours on days -6 to -3 before the first chemotherapy course and then on days 2-15 and 23-26 of all chemotherapy courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients achieving stable disease receive a maximum of 4 courses Patients achieving complete or partial response receive a maximum of 6 courses
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 12-43 patients will be accrued for this study within 12-28 months
Determine the antitumor activity of dacarbazine mitomycin doxorubicin and cisplatin plus sargramostim GM-CSF in patients with advanced persistent or recurrent leiomyosarcoma of the uterus
Determine the nature and degree of toxicity of this regimen in these patients
OUTLINE Patients receive dacarbazine IV over 2 hours followed by mitomycin IV over 2-5 minutes doxorubicin IV over 2-5 minutes and cisplatin IV over 2 hours on day 1 Patients also receive sargramostim GM-CSF subcutaneously SC once every 12 hours on days -6 to -3 before the first chemotherapy course and then on days 2-15 and 23-26 of all chemotherapy courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients achieving stable disease receive a maximum of 4 courses Patients achieving complete or partial response receive a maximum of 6 courses
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 12-43 patients will be accrued for this study within 12-28 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-0087K | None | None | None |