Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GOG-0087K |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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 person's 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.
OBJECTIVES:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sargramostim | Biological | |||
| cisplatin | Drug | |||
| dacarbazine | Drug | |||
| doxorubicin hydrochloride | Drug | |||
| mitomycin C | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed primary leiomyosarcoma (LMS) of the uterus
At least 1 unidimensionally measurable target lesion
Ineligible for a higher priority Gynecologic Oncology Group protocol (if one exists), including any active phase III protocol for the same population
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Harry J. Long, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1781 | United States | ||
| University of Colorado Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16051328 | Result | Long HJ 3rd, Blessing JA, Sorosky J. Phase II trial of dacarbazine, mitomycin, doxorubicin, and cisplatin with sargramostim in uterine leiomyosarcoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Nov;99(2):339-42. doi: 10.1016/j.ygyno.2005.06.002. Epub 2005 Jul 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Denver |
| Colorado |
| 80010 |
| United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5001 | United States |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | 60612-3864 | United States |
| Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242-1009 | United States |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland | 20892-1182 | United States |
| Tuft-New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905-0001 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103-1489 | United States |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York | 11794-8091 | United States |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | 27599-7295 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1065 | United States |
| Barrett Cancer Center | Cincinnati | Ohio | 45267-0526 | United States |
| University of Oklahoma College of Medicine | Oklahoma City | Oklahoma | 73190 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001-3788 | United States |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104-4283 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0587 | United States |
| Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| Norwegian Radium Hospital | Oslo | N-0310 | Norway |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C081222 | sargramostim |
| D002945 | Cisplatin |
| D003606 | Dacarbazine |
| D004317 | Doxorubicin |
| D016685 | Mitomycin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D001389 | Azirines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided