Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery
Stage I Uterine Sarcoma AJCC v7, Uterine Corpus Leiomyosarcoma
About this trial
This is an interventional treatment trial for Stage I Uterine Sarcoma AJCC v7
Eligibility Criteria
Inclusion Criteria:
Patients with high-risk uterine leiomyosarcoma (LMS), Federation of Gynecology and Obstetrics (FIGO) stage I (confined to corpus +/- cervix); patients with known uterine serosa involvement are not eligible; patients should have had, at least, a complete hysterectomy (including removal of the cervix); bilateral salpingo-oophorectomy is not required
- Institutional pathology review calls the uterine leiomyosarcoma ?high grade?
- Additionally, if the pathology report indicates a mitotic rate, the mitotic rate should be greater than or equal to 5 mitoses/10 high-power field
- All patients must be no longer than 12 weeks (3 months) from surgical resection of cancer at the time of enrollment on study; if a patient requires a second operation to complete her surgery, i.e., trachelectomy to remove the cervix and/or bilateral salpingo-oophorectomy (BSO), the 12 weeks may be counted from the time of the second operation
- Patients who had a ?morcellation? hysterectomy procedure that involved morcellation within the peritoneal cavity are eligible IF a second operation is performed and biopsies from the second procedure show no evidence of leiomyosarcoma
- All patients must have no evidence of persistent or metastatic disease as documented by a post-resection computed tomography (CT) of the chest/abdomen/pelvis or by CT chest + magnetic resonance imaging (MRI) abdomen/pelvis; the post-resection imaging studies should be performed within 4 weeks of registration on study
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL (ANC >= 1.5 x 10^9/liter [L])
- Platelets greater than or equal to 100,000/mcL (platelets >= 100 x 10^9/L)
- Hemoglobin greater than 8.0 g/dL (= 80 g/L or 4.9 mmol/L)
- Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
- Bilirubin* within normal range
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST])* and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT])* less than or equal to 2.5 times ULN
- Alkaline phosphatase* less than or equal to 2.5 x ULN
- * Patients with a history of Gilbert?s syndrome may be eligible provided total bilirubin is less than or equal to 1.5 x ULN and the AST, ALT, and alkaline phosphatase meet the criteria detailed
- Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
- Patients with Gynecologic Oncology Group (GOG) performance status of 0 or 1 OR Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 OR Karnofsky performance status (PS) >= 80%
- Patients who have met the pre-entry requirements specified
- Patients must have signed an approved informed consent
- Patients participating through United States (U.S.) sites must sign an approved and authorization permitting release of personal health information
- Patients should be free of active infection requiring antibiotics (with the exception of an uncomplicated urinary tract infection [UTI])
Exclusion Criteria:
- Patients who have had prior therapy with docetaxel, gemcitabine hydrochloride, or doxorubicin hydrochloride at any time in their history
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are ineligible if there is any evidence of other malignancy being present within the last five years; patients are also ineligible if their previous cancer treatment contraindicates this protocol therapy
- Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel) or other drugs formulated with polysorbate 80
- Patients with GOG performance status of 2, 3 or 4; or ECOG performance status of 2, 3 or 4
- Patients who are breast-feeding
Patients with a known history of congestive heart failure or cardiac ejection fraction < 50% (or less than institutional normal limits); echocardiogram (ECHO) or multigated acquisition scan (MUGA) is not required prior to enrollment; for patients assigned to the chemotherapy arm, an ECHO or MUGA should be done within 6 months of day 1 of gemcitabine-docetaxel treatment
- Patients who enroll on study and are randomized to Regimen I (chemotherapy ) and then are found on baseline ECHO or MUGA to have cardiac ejection fraction < 50% or below institutional normal will remain ON study; such patients will receive gemcitabine + docetaxel for 4 cycles but will NOT receive any doxorubicin treatment; they will continue treatment follow-up as outlined for all patients assigned to Regimen I
- Patients with a history of prior whole pelvic radiation
- Concurrent treatment with hormone replacement therapy is permitted at the discretion of the treating physician; patients who have been taking hormonal/hormone blocking agents for breast cancer or breast cancer prevention or other indication are eligible; use of anti-hormonal agents (tamoxifen, medroxyprogesterone, aromatase inhibitors) is permitted at the discretion of the treating physician; documentation of concurrent medications is required
- Patients with recurrent uterine LMS
- Patients who are known to be human immunodeficiency virus (HIV) positive are not eligible
- Patients with gross residual or metastatic tumor findings following complete surgical treatment for uterine LMS
Sites / Locations
- Tennessee Valley Gynecologic Oncology
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Regional Hospital
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial Hospital
- CHI Saint Vincent Cancer Center Hot Springs
- Kaiser Permanente-Deer Valley Medical Center
- Sutter Auburn Faith Hospital
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Sutter Davis Hospital
- Kaiser Permanente-Fremont
- Kaiser Permanente-Fresno
- UC San Diego Moores Cancer Center
- Loma Linda University Medical Center
- Kaiser Permanente Los Angeles Medical Center
- Memorial Medical Center
- Kaiser Permanente-Modesto
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Sutter Cancer Research Consortium
- Kaiser Permanente-Oakland
- Palo Alto Medical Foundation Health Care
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Roseville
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- Sutter Medical Center Sacramento
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Zuckerberg San Francisco General Hospital
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- UCSF Medical Center-Mission Bay
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Kaiser Permanente-Santa Rosa
- Sutter Pacific Medical Foundation
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Palo Alto Medical Foundation-Sunnyvale
- Olive View-University of California Los Angeles Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- University of Colorado Hospital
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Colorado Cancer Research Program NCORP
- Mercy Medical Center
- Southwest Oncology PC
- Comprehensive Cancer Care and Research Institute of Colorado LLC
- Swedish Medical Center
- Mountain Blue Cancer Care Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Hartford Hospital
- The Hospital of Central Connecticut
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Regional Hematology and Oncology PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- Nanticoke Memorial Hospital
- Christiana Care Health System-Wilmington Hospital
- Sibley Memorial Hospital
- Florida Hospital Cancer Institute Altamonte
- Florida Hospital Kissimmee
- Florida Hospital Orlando
- Florida Urology Associates-Orlando
- Florida Hospital East Orlando
- Florida Hospital Cancer Institute Winter Park
- Piedmont Hospital
- Northside Hospital
- Dekalb Medical Center
- Northeast Georgia Medical Center-Gainesville
- Memorial Health University Medical Center
- Summit Cancer Care-Memorial
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Low Country Cancer Care Associates PC
- Hawaii Oncology Inc-Pali Momi
- Pali Momi Medical Center
- The Cancer Center of Hawaii-Pali Momi
- Hawaii Cancer Care Inc-POB II
- Hawaii Oncology Inc-POB I
- Island Urology
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Hawaii Oncology Inc-Kuakini
- Kuakini Medical Center
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and Children
- Tripler Army Medical Center
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Luke's Mountain States Tumor Institute
- Kootenai Medical Center
- Saint Luke's Mountain States Tumor Institute - Fruitland
- Saint Joseph Regional Medical Center
- Saint Luke's Mountain States Tumor Institute - Meridian
- Saint Luke's Mountain States Tumor Institute - Nampa
- Kootenai Cancer Center
- Kootenai Cancer Clinic
- Saint Luke's Mountain States Tumor Institute-Twin Falls
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Mount Sinai Hospital Medical Center
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- Rush University Medical Center
- University of Chicago Comprehensive Cancer Center
- Carle on Vermilion
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Sudarshan K Sharma MD Limited-Gynecologic Oncology
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Good Samaritan Regional Health Center
- UC Comprehensive Cancer Center at Silver Cross
- Illinois CancerCare-Ottawa Clinic
- Radiation Oncology of Northern Illinois
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Central Illinois Hematology Oncology Center
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Cancer Care Specialists of Illinois-Swansea
- Carle Cancer Center
- The Carle Foundation Hospital
- Rush-Copley Healthcare Center
- Saint Vincent Hospital and Health Care Center
- Franciscan Saint Anthony Health-Michigan City
- Woodland Cancer Care Center
- Memorial Regional Cancer Center Day Road
- Reid Health
- Memorial Hospital of South Bend
- Mary Greeley Medical Center
- McFarland Clinic PC - Ames
- McFarland Clinic PC-Boone
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- McFarland Clinic PC-Trinity Cancer Center
- University of Iowa/Holden Comprehensive Cancer Center
- McFarland Clinic PC-Jefferson
- McFarland Clinic PC-Marshalltown
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Kansas Institute of Medicine Cancer and Blood Center
- Minimally Invasive Surgery Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Menorah Medical Center
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Kansas City NCI Community Oncology Research Program
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Wichita
- Via Christi Regional Medical Center
- Wesley Medical Center
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Oncology Hematology Care Inc-Crestview
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- Jewish Hospital Medical Center Northeast
- Jewish Hospital Medical Center South
- Woman's Hospital
- Ochsner Medical Center Jefferson
- Maine Medical Center- Scarborough Campus
- University of Maryland/Greenebaum Cancer Center
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Walter Reed National Military Medical Center
- Union Hospital of Cecil County
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
- Baystate Medical Center
- Bixby Medical Center
- Hickman Cancer Center
- University of Michigan Comprehensive Cancer Center
- Wayne State University/Karmanos Cancer Institute
- Weisberg Cancer Treatment Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Mercy Memorial Hospital
- Monroe Cancer Center
- Toledo Clinic Cancer Centers-Monroe
- Saint Dominic-Jackson Memorial Hospital
- University of Mississippi Medical Center
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Centerpoint Medical Center LLC
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Saint Luke's Hospital of Kansas City
- Heartland Hematology and Oncology Associates Incorporated
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Barnes-Jewish Hospital
- Washington University School of Medicine
- Missouri Baptist Medical Center
- Mercy Hospital Saint Louis
- Sainte Genevieve County Memorial Hospital
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- CHI Health Saint Francis
- Heartland Hematology and Oncology
- CHI Health Good Samaritan
- Saint Elizabeth Regional Medical Center
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Hematology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- University of Nebraska Medical Center
- Midlands Community Hospital
- Women's Cancer Center of Nevada
- Center of Hope at Renown Medical Center
- Renown Regional Medical Center
- Dartmouth Hitchcock Medical Center
- Memorial Sloan Kettering Basking Ridge
- Cooper Hospital University Medical Center
- Virtua Memorial
- MD Anderson Cancer Center at Cooper-Voorhees
- Virtua Voorhees
- University of New Mexico Cancer Center
- Southwest Gynecologic Oncology Associates Inc
- Women's Cancer Care Associates LLC
- New York-Presbyterian/Brooklyn Methodist Hospital
- Memorial Sloan Kettering Commack
- Memorial Sloan Kettering Westchester
- Memorial Sloan Kettering Cancer Center
- University of Rochester
- Memorial Sloan Kettering Rockville Centre
- Memorial Sloan Kettering Sleepy Hollow
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- Randolph Hospital
- AdventHealth Infusion Center Asheville
- Cone Health Cancer Center at Alamance Regional
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Presbyterian Medical Center
- Oncology Specialists of Charlotte
- Southern Oncology Specialists-Charlotte
- Atrium Health Cabarrus/LCI-Concord
- Duke University Medical Center
- Cone Health Cancer Center
- AdventHealth Hendersonville
- Lake Norman Hematology Oncology Specialists-Huntersville
- Southern Oncology Specialists-Huntersville
- Matthews Radiation Oncology Center
- Novant Health Cancer Specialists-Matthews
- Cone Heath Cancer Center at Mebane
- Lake Norman Hematology Oncology Specialists-Mooresville
- Annie Penn Memorial Hospital
- Wake Forest University Health Sciences
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Summa Akron City Hospital/Cooper Cancer Center
- UHHS-Chagrin Highlands Medical Center
- Strecker Cancer Center-Belpre
- Toledo Clinic Cancer Centers-Bowling Green
- Aultman Health Foundation
- Dayton Physicians LLC-Miami Valley South
- Miami Valley Hospital South
- Adena Regional Medical Center
- Oncology Hematology Care Inc-Eden Park
- Oncology Hematology Care Inc-Mercy West
- University of Cincinnati/Barrett Cancer Center
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc - Anderson
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- Oncology Hematology Care Inc-Blue Ash
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve University
- Ohio State University Comprehensive Cancer Center
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Dayton NCI Community Oncology Research Program
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Oncology Hematology Care Inc-Healthplex
- Armes Family Cancer Center
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-Atrium
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Greater Dayton Cancer Center
- Kettering Medical Center
- Fairfield Medical Center
- Lancaster Radiation Oncology
- Lima Memorial Hospital
- Marietta Memorial Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- UH Seidman Cancer Center at Landerbrook Health Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- Dayton Physicians LLC-Signal Point
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- Southern Ohio Medical Center
- Dayton Physicians LLC-Wilson
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- ProMedica Flower Hospital
- Mercy Hospital of Tiffin
- The Toledo Hospital/Toledo Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Dayton Physicians LLC-Upper Valley
- Upper Valley Medical Center
- University Hospitals Sharon Health Center
- Fulton County Health Center
- Saint Ann's Hospital
- UHHS-Westlake Medical Center
- Wright-Patterson Medical Center
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Oncology and Hematology Care Southeast
- Bay Area Hospital
- Legacy Mount Hood Medical Center
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Legacy Meridian Park Hospital
- Abington Memorial Hospital
- UPMC-Heritage Valley Health System Beaver
- Saint Luke's University Hospital-Bethlehem Campus
- Geisinger Medical Center
- Easton Hospital
- Ephrata Cancer Center
- Ephrata Community Hospital
- Adams Cancer Center
- UPMC Cancer Centers - Arnold Palmer Pavilion
- Cherry Tree Cancer Center
- Geisinger Medical Center-Cancer Center Hazleton
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- Armstrong Center for Medicine and Health
- UPMC Cancer Center at UPMC McKeesport
- UPMC-Coraopolis/Heritage Valley Radiation Oncology
- Paoli Memorial Hospital
- Fox Chase Cancer Center
- Temple University Hospital
- UPMC-Magee Womens Hospital
- UPMC-Presbyterian Hospital
- UPMC-Saint Margaret
- West Penn Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- UPMC-Shadyside Hospital
- UPMC Jefferson Regional Radiation Oncology
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- UPMC Cancer Center at UPMC Northwest
- Geisinger Medical Group
- UPMC Uniontown Hospital Radiation Oncology
- UPMC Washington Hospital Radiation Oncology
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- Lankenau Medical Center
- WellSpan Health-York Cancer Center
- WellSpan Health-York Hospital
- Women and Infants Hospital
- Medical University of South Carolina
- Greenville Health System Cancer Institute-Easley
- Greenville Health System Cancer Institute-Andrews
- Saint Francis Hospital
- Greenville Health System Cancer Institute-Butternut
- Greenville Health System Cancer Institute-Faris
- Greenville Memorial Hospital
- Saint Francis Cancer Center
- Greenville Health System Cancer Institute-Eastside
- Greenville Health System Cancer Institute-Greer
- Greenville Health System Cancer Institute-Seneca
- Greenville Health System Cancer Institute-Spartanburg
- Memorial Hospital
- Pulmonary Medicine Center of Chattanooga-Hixson
- University of Tennessee - Knoxville
- Memorial GYN Plus
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- University of Texas Medical Branch
- UTMB Cancer Center at Victory Lakes
- Inova Fairfax Hospital
- Fredericksburg Oncology Inc
- Carilion Clinic Gynecological Oncology
- Providence Regional Cancer System-Aberdeen
- Cancer Care Center at Island Hospital
- MultiCare Auburn Medical Center
- Virginia Mason Bainbridge Island Medical Center
- Overlake Hospital Medical Center
- Swedish Cancer Institute-Eastside Oncology Hematology
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Medical Center-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Virginia Mason Federal Way Medical Center
- Saint Francis Hospital
- Tacoma/Valley Radiation Oncology Centers-Gig Harbor
- MultiCare Gig Harbor Medical Park
- Swedish Cancer Institute-Issaquah
- Northwest Cancer Clinic
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Virginia Mason Lynnwood Medical Center
- Jefferson Healthcare
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Peninsula Cancer Center
- MultiCare Good Samaritan Hospital
- Tacoma/Valley Radiation Oncology Centers-Puyallup
- Virginia Mason Medical Center
- Minor and James Medical PLLC
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- Providence Regional Cancer System-Shelton
- Rockwood Clinic Cancer Treatment Center-Valley
- Rockwood Cancer Treatment Center-DHEC-Downtown
- Evergreen Hematology and Oncology PS
- Rockwood North Cancer Treatment Center
- Tacoma/Valley Radiation Oncology Centers-Jackson Hall
- Franciscan Research Center-Northwest Medical Plaza
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- Northwest NCI Community Oncology Research Program
- Tacoma/Valley Radiation Oncology Centers-Saint Joe's
- PeaceHealth Southwest Medical Center
- Legacy Salmon Creek Hospital
- Providence Saint Mary Regional Cancer Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Providence Regional Cancer System-Yelm
- Monongalia Hospital
- Aurora Health Center-Fond du Lac
- Aurora Cancer Care-Grafton
- Aurora BayCare Medical Center
- UW Cancer Center Johnson Creek
- Gundersen Lutheran Medical Center
- University of Wisconsin Hospital and Clinics
- Aurora Bay Area Medical Group-Marinette
- Aurora Saint Luke's Medical Center
- Froedtert and the Medical College of Wisconsin
- Aurora Sinai Medical Center
- Vince Lombardi Cancer Clinic - Oshkosh
- Vince Lombardi Cancer Clinic-Sheboygan
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora West Allis Medical Center
- Rocky Mountain Oncology
- Cheyenne Regional Medical Center-West
- Big Horn Basin Cancer Center
- Billings Clinic-Cody
- Welch Cancer Center
- Universitair Ziekenhuis Antwerpen
- Institut Bergonie Cancer Center
- Centre Georges-Francois Leclerc
- Centre Leon Berard
- Centre Catherine de Sienne
- University Medical Center Groningen
- University of Oslo
- Hospital Clinico San Carlos
- Addenbrookes Hospital-Medical School
- University College London Hospital
- Christie Hospital
- Weston Park Hospital
- Beatson Oncology Center
- Institute of Cancer Research - Chelsea
- Hospital Universitario
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Arm I (chemotherapy)
Arm II (no treatment)
Patients receive adjuvant gemcitabine hydrochloride IV over 70-90 minutes on days 1 and 8 and docetaxel IV over 30-60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo CT and/or MRI. Patients with no evidence of disease receive doxorubicin hydrochloride IV every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive filgrastim SC on days 2-8 or pegfilgrastim SC on day 2 or 3.
Patients undergo clinical observation.