Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000405892 |
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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy, such as docetaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim works in treating patients with advanced, persistent, or recurrent uterine leiomyosarcoma.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to prior pelvic radiotherapy (yes vs no).
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 9-15 OR pegfilgrastim SC on day 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
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 |
|---|---|---|---|---|
| filgrastim | Biological | |||
| pegfilgrastim | Biological | |||
| docetaxel | Drug | |||
| gemcitabine hydrochloride | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Antitumor activity | ||
| Toxicity |
Not provided
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed uterine leiomyosarcoma
Measurable disease
At least 1 target lesion
Ineligible for higher priority GOG protocols (i.e., any active phase III GOG protocol for the same patient 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 |
|---|---|---|
| Martee L. Hensley, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Gregory P. Sutton, MD | St. Vincent Gynecologic Oncology at St. Vincent Oncology Center |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Medical Center - Los Angeles | Los Angeles | California | 90027 | United States | ||
| Jonsson Comprehensive Cancer Center at UCLA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18534250 | Result | Hensley ML, Blessing JA, Mannel R, Rose PG. Fixed-dose rate gemcitabine plus docetaxel as first-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II trial. Gynecol Oncol. 2008 Jun;109(3):329-34. doi: 10.1016/j.ygyno.2008.03.010. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Los Angeles |
| California |
| 90095-1781 |
| United States |
| Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford | Connecticut | 06102-5037 | United States |
| New Britain General Hospital | New Britain | Connecticut | 06050 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| MBCCOP-Medical College of Georgia Cancer Center | Augusta | Georgia | 30912 | United States |
| Medical Center of Central Georgia | Macon | Georgia | 31208 | United States |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | 31403-3089 | United States |
| Rush-Copley Cancer Care Center | Aurora | Illinois | 60507 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Hinsdale Hematology Oncology Associates | Hinsdale | Illinois | 60521 | United States |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | United States |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242 | United States |
| Woman's Hospital | Baton Rouge | Louisiana | 70815 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65802 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Methodist Cancer Center at Methodist Hospital - Omaha | Omaha | Nebraska | 68114 | United States |
| Fox Chase Virtua Health Cancer Program - Marlton | Marlton | New Jersey | 08053 | United States |
| UMDNJ University Hospital | Newark | New Jersey | 07103 | United States |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees Township | New Jersey | 08043 | United States |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico | 87131-5636 | United States |
| New York Oncology Hematology, PC at Albany Regional Cancer Care | Albany | New York | 12208 | United States |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Stony Brook University Cancer Center | Stony Brook | New York | 11794-8174 | United States |
| Hope A Women's Cancer Center | Asheville | North Carolina | 28801 | United States |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267 | United States |
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214-3998 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Lake/University Ireland Cancer Center | Mentor | Ohio | 44060 | United States |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Cancer Care Associates - Midtown Tulsa | Tulsa | Oklahoma | 74104 | United States |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Drexel University College of Medicine - Center City Hahnemann Campus | Philadelphia | Pennsylvania | 19102 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | United States |
| Women and Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Baptist Centers for Cancer Care | Memphis | Tennessee | 38120 | United States |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| 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 |
|---|---|
| D000069585 | Filgrastim |
| C455861 | pegfilgrastim |
| D000077143 | Docetaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided