ClinicalTrials.gov record
Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma
ClinicalTrials.gov ID: NCT01012297
Public ClinicalTrials.gov record NCT01012297. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase III Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Bevacizumab (NSC #704865) Versus Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Placebo in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized phase III trial is studying gemcitabine hydrochloride, docetaxel, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, docetaxel, and a placebo in treating patients with advanced or recurrent uterine leiomyosarcoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether gemcitabine hydrochloride and docetaxel are more effective when given with or without bevacizumab in treating uterine leiomyosarcoma.
Study identification
- NCT ID
- NCT01012297
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 107 participants
Conditions and interventions
Conditions
Interventions
- Bevacizumab Biological
- Docetaxel Drug
- Filgrastim Biological
- Gemcitabine Hydrochloride Drug
- Pegfilgrastim Biological
- Placebo Other
Biological · Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2009 (Type not available)
- Primary completion
- Sep 2015 (Actual)
- Completion
- Sep 2015 (Actual)
- Last update posted
- Jun 24, 2026
2009 – 2015
United States locations
- U.S. sites
- 201
- U.S. states
- 36
- U.S. cities
- 141
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Saint Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | 91505 | — |
| John Muir Medical Center-Concord Campus | Concord | California | 94520 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | — |
| Los Angeles County-USC Medical Center | Los Angeles | California | 90033 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | — |
| Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View | California | 94040 | — |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| University of California San Diego | San Diego | California | 92103 | — |
| UCSF Medical Center-Mount Zion | San Francisco | California | 94115 | — |
| Olive View-University of California Los Angeles Medical Center | Sylmar | California | 91342 | — |
| John Muir Medical Center-Walnut Creek | Walnut Creek | California | 94598 | — |
| The Medical Center of Aurora | Aurora | Colorado | 80012 | — |
| University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | — |
| Boulder Community Hospital | Boulder | Colorado | 80301 | — |
| Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | 80907 | — |
| Porter Adventist Hospital | Denver | Colorado | 80210 | — |
| Exempla Saint Joseph Hospital | Denver | Colorado | 80218 | — |
| Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado | 80218 | — |
| Rose Medical Center | Denver | Colorado | 80220 | — |
| Colorado Cancer Research Program CCOP | Denver | Colorado | 80224-2522 | — |
| Rocky Mountain Gynecologic Oncology PC | Englewood | Colorado | 80110 | — |
| Swedish Medical Center | Englewood | Colorado | 80113 | — |
| Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado | 81502 | — |
| North Colorado Medical Center | Greeley | Colorado | 80631 | — |
| Saint Anthony Hospital | Lakewood | Colorado | 80228 | — |
| Littleton Adventist Hospital | Littleton | Colorado | 80122 | — |
| Sky Ridge Medical Center | Lone Tree | Colorado | 80124 | — |
| Longmont United Hospital | Longmont | Colorado | 80501 | — |
| McKee Medical Center | Loveland | Colorado | 80539 | — |
| Parker Adventist Hospital | Parker | Colorado | 80138 | — |
| Saint Mary Corwin Medical Center | Pueblo | Colorado | 81004 | — |
| North Suburban Medical Center | Thornton | Colorado | 80229 | — |
| SCL Health Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | — |
| Beebe Medical Center | Lewes | Delaware | 19958 | — |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | — |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | — |
| Mercy Hospital | Miami | Florida | 33133 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| Florida Hospital Orlando | Orlando | Florida | 32803 | — |
| UF Cancer Center at Orlando Health | Orlando | Florida | 32806 | — |
| Georgia Regents University Medical Center | Augusta | Georgia | 30912 | — |
| John B Amos Cancer Center | Columbus | Georgia | 31904 | — |
| Memorial University Medical Center | Savannah | Georgia | 31404 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale | Illinois | 60521 | — |
| Memorial Medical Center | Springfield | Illinois | 62781 | — |
| Cadence Cancer Center in Warrenville | Warrenville | Illinois | 60555 | — |
| Elkhart Clinic | Elkhart | Indiana | 46514-2098 | — |
| Michiana Hematology Oncology PC-Elkhart | Elkhart | Indiana | 46514 | — |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | — |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Franciscan Saint Francis Health-Indianapolis | Indianapolis | Indiana | 46237 | — |
| Gynecologic Oncology of Indiana | Indianapolis | Indiana | 46237 | — |
| Saint Vincent Oncology Center | Indianapolis | Indiana | 46260 | — |
| Community Howard Regional Health | Kokomo | Indiana | 46904 | — |
| IU Health La Porte Hospital | La Porte | Indiana | 46350 | — |
| Michiana Hematology Oncology PC-Mishawaka | Mishawaka | Indiana | 46545 | — |
| Saint Joseph Regional Medical Center-Mishawaka | Mishawaka | Indiana | 46545 | — |
| Michiana Hematology Oncology PC-Plymouth | Plymouth | Indiana | 46563 | — |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | — |
| Michiana Hematology Oncology PC-South Bend | South Bend | Indiana | 46601 | — |
| South Bend Clinic | South Bend | Indiana | 46617 | — |
| Northern Indiana Cancer Research Consortium CCOP | South Bend | Indiana | 46628 | — |
| Michiana Hematology Oncology PC-Westville | Westville | Indiana | 46391 | — |
| Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa | 50325 | — |
| Mercy Cancer Center-West Lakes | Clive | Iowa | 50325 | — |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | — |
| Iowa Oncology Research Association CCOP | Des Moines | Iowa | 50309 | — |
| Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | 50309 | — |
| Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa | 50314 | — |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | — |
| Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| Methodist West Hospital | West Des Moines | Iowa | 50266-7700 | — |
| Mercy Medical Center-West Lakes | West Des Moines | Iowa | 50266 | — |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Norton Hospital Pavilion and Medical Campus | Louisville | Kentucky | 40202 | — |
| The James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky | 40202 | — |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | — |
| MedStar Franklin Square Medical Center/Weinberg Cancer Institute | Baltimore | Maryland | 21237 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | — |
| Union Hospital of Cecil County | Elkton | Maryland | 21921 | — |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | — |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | — |
| Spectrum Health Big Rapids Hospital | Big Rapids | Michigan | 49307 | — |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | 49503 | — |
| Mercy Health Saint Mary's | Grand Rapids | Michigan | 49503 | — |
| Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | 49503 | — |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | — |
| Mercy Health Mercy Campus | Muskegon | Michigan | 49444 | — |
| Michiana Hematology Oncology PC-Niles | Niles | Michigan | 49120 | — |
| Spectrum Health Reed City Hospital | Reed City | Michigan | 49677 | — |
| Lakeland Hospital | Saint Joseph | Michigan | 49085 | — |
| Marie Yeager Cancer Center | Saint Joseph | Michigan | 49085 | — |
| Munson Medical Center | Traverse City | Michigan | 49684 | — |
| Metro Health Hospital | Wyoming | Michigan | 49519 | — |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | — |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | — |
| Fairview-Southdale Hospital | Edina | Minnesota | 55435 | — |
| Unity Hospital | Fridley | Minnesota | 55432 | — |
| Hutchinson Area Health Care | Hutchinson | Minnesota | 55350 | — |
| Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | 55109 | — |
| Saint John's Hospital - Healtheast | Maplewood | Minnesota | 55109 | — |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| New Ulm Medical Center | New Ulm | Minnesota | 56073 | — |
| North Memorial Medical Health Center | Robbinsdale | Minnesota | 55422 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Metro-Minnesota NCI Community Oncology Research Program | Saint Louis Park | Minnesota | 55416 | — |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| United Hospital | Saint Paul | Minnesota | 55102 | — |
| Saint Francis Regional Medical Center | Shakopee | Minnesota | 55379 | — |
| Lakeview Hospital | Stillwater | Minnesota | 55082 | — |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | — |
| Rice Memorial Hospital | Willmar | Minnesota | 56201 | — |
| Minnesota Oncology and Hematology PA-Woodbury | Woodbury | Minnesota | 55125 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Cancer Research for the Ozarks NCORP | Springfield | Missouri | 65804 | — |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | — |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| Women's Cancer Center of Nevada | Las Vegas | Nevada | 89169 | — |
| Center of Hope at Renown Medical Center | Reno | Nevada | 89502 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Cooper Hospital University Medical Center | Camden | New Jersey | 08103 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Virtua Memorial | Mount Holly | New Jersey | 08060 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| UMDNJ - Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | — |
| Overlook Hospital | Summit | New Jersey | 07902 | — |
| Virtua West Jersey Hospital Voorhees | Voorhees Township | New Jersey | 08043 | — |
| University of New Mexico | Albuquerque | New Mexico | 87102 | — |
| Southwest Gynecologic Oncology Associates Inc | Albuquerque | New Mexico | 87106 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | — |
| Memorial Medical Center - Las Cruces | Las Cruces | New Mexico | 88011 | — |
| Women's Cancer Care Associates LLC | Albany | New York | 12208 | — |
| State University of New York Downstate Medical Center | Brooklyn | New York | 11203 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | — |
| Carolinas HealthCare System NorthEast | Concord | North Carolina | 28025 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Summa Akron City Hospital/Cooper Cancer Center | Akron | Ohio | 44304 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | 44111 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | — |
| Kettering Medical Center | Kettering | Ohio | 45429 | — |
| Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | 44124 | — |
| Lake University Ireland Cancer Center | Mentor | Ohio | 44060 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Tulsa Cancer Institute | Tulsa | Oklahoma | 74146 | — |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | — |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | 18103 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Geisinger Medical Center-Cancer Center Hazleton | Hazleton | Pennsylvania | 18201 | — |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | — |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| UPMC-Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | — |
| Geisinger Medical Group | State College | Pennsylvania | 16801 | — |
| Reading Hospital | West Reading | Pennsylvania | 19611 | — |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | — |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Sanford Cancer Center-Oncology Clinic | Sioux Falls | South Dakota | 57104 | — |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | — |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | — |
| Parkland Memorial Hospital | Dallas | Texas | 75235 | — |
| Zale Lipshy University Hospital | Dallas | Texas | 75235 | — |
| Clements University Hospital | Dallas | Texas | 75390 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| Baylor All Saints Medical Center at Fort Worth | Fort Worth | Texas | 76104 | — |
| M D Anderson Cancer Center | Houston | Texas | 77030 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
| Cancer Center of Western Wisconsin | New Richmond | Wisconsin | 54017 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01012297, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 24, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01012297 live on ClinicalTrials.gov.