Study Stopped
The study was targeted to accrue 130 patients, but closed early for futility.
Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma
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
4 other identifiers
interventional
107
1 country
201
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2009
Longer than P75 for phase_3
201 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 12, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
July 14, 2017
CompletedSeptember 2, 2020
August 1, 2020
5.8 years
November 12, 2009
January 26, 2017
August 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan. Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Secondary Outcomes (3)
Overall Survival
Up to 5 years
Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0
Up to 5 years
Objective Response Rate as Measured by RECIST 1.1 Criteria
Up to 5 years
Study Arms (2)
Arm I Gem+Doce+Placebo
EXPERIMENTALPatients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Arm II Gem+Doce+Bev
EXPERIMENTALPatients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Interventions
Given IV
Given IV
Given SC
Given IV
Given SC
Eligibility Criteria
You may qualify if:
- Patients must have advanced or recurrent uterine leiomyosarcoma with documented disease progression; histologic confirmation of the original primary tumor is required
- All patients must have measurable disease as defined by RECIST 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be \>= 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray; lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
- Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- Patients must have a GOG Performance Status of 0, 1, or 2
- Patients must have recovered from effects of recent surgery, radiotherapy or other therapy
- Patients should be free of active infection requiring antibiotics (with the exception of an uncomplicated UTI)
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to first day of study treatment; continuation of hormone replacement therapy is permitted
- Platelet count greater than or equal to 100,000/mm\^3
- ANC count greater than or equal to 1,500/mm\^3
- Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), per NCI CTCAE Version 4.0 Grade 1
- Bilirubin within normal range (CTCAE Version 4 Grade 0)
- SGOT and alkaline phosphatase less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1)
- SGOT less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1
- Alkaline phosphatase less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1
- Neuropathy (sensory and motor) less than or equal to Grade 1 per the CTCAE Version 4.0.
- +6 more criteria
You may not qualify if:
- Patients who have received prior cytotoxic chemotherapy for management of uterine sarcoma; patients who have received prior VEGF-pathway targeted agent such as bevacizumab, PTK787, VEGF-trap, or who have received prior treatment with a multi-kinase inhibitor such as sorafenib or sunitinib are not eligible
- Patients who have had prior therapy with docetaxel or gemcitabine or bevacizumab
- Patients with a history of other invasive malignancies, with the exceptions of non-melanoma skin cancer, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels; (necessary use of warfarin or low molecular weight heparin is permitted, provided the INR is maintained in the therapeutic range of approximately 2-3)
- Patients with major surgery or significant traumatic injury within 28 days prior to study entry
- Patients with a history of abdominal fistula or perforation within the past 12 months
- Patients with a current, serious, non-healing wound, ulcer, or bone fracture
- Patients with history or evidence upon physical examination of CNS disease, including history of primary brain tumor, or any history of brain metastases, or seizures not controlled with standard medical therapy
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
- Cardiovascular function; specifically, patient may not have:
- Uncontrolled hypertension, defined as systolic \> 150 mm Hg or diastolic \> 100 mm Hg in a patient with no history of hypertension; patients with a history of hypertension before enrollment on study are permitted, but such patients must have BP less than or equal to 140/90 mmHg; use of blood pressure medications to achieve and maintain blood pressure control is permitted
- Myocardial infarction or unstable angina within 6 months of the first date of bevacizumab/placebo therapy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication; women who have received prior treatment with an anthracycline (including doxorubicin and/or liposomal doxorubicin) and have an ejection fraction \< 50% will be excluded from the study
- Grade 1, Category 2 or greater, peripheral vascular disease; patient cannot have anything worse than mild, symptomatic claudication with exercise
- History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of bevacizumab/placebo therapy
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- NRG Oncologycollaborator
Study Sites (201)
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
John Muir Medical Center-Concord Campus
Concord, California, 94520, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Los Angeles County-USC Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, 94040, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
University of California San Diego
San Diego, California, 92103, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
Olive View-University of California Los Angeles Medical Center
Sylmar, California, 91342, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, 94598, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Exempla Saint Joseph Hospital
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Colorado Cancer Research Program CCOP
Denver, Colorado, 80224-2522, United States
Rocky Mountain Gynecologic Oncology PC
Englewood, Colorado, 80110, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81502, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Saint Anthony Hospital
Lakewood, Colorado, 80228, United States
Littleton Adventist Hospital
Littleton, Colorado, 80122, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Parker Adventist Hospital
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Mercy Hospital
Miami, Florida, 33133, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Florida Hospital Orlando
Orlando, Florida, 32803, United States
UF Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
Georgia Regents University Medical Center
Augusta, Georgia, 30912, United States
John B Amos Cancer Center
Columbus, Georgia, 31904, United States
Memorial University Medical Center
Savannah, Georgia, 31404, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, 60521, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Cadence Cancer Center in Warrenville
Warrenville, Illinois, 60555, United States
Elkhart Clinic
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Franciscan Saint Francis Health-Indianapolis
Indianapolis, Indiana, 46237, United States
Gynecologic Oncology of Indiana
Indianapolis, Indiana, 46237, United States
Saint Vincent Oncology Center
Indianapolis, Indiana, 46260, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, 46563, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, 46601, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Northern Indiana Cancer Research Consortium CCOP
South Bend, Indiana, 46628, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, 46391, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa Oncology Research Association CCOP
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, 40202, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
Michiana Hematology Oncology PC-Niles
Niles, Michigan, 49120, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677, United States
Lakeland Hospital
Saint Joseph, Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview-Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Metro-Minnesota NCI Community Oncology Research Program
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, 65804, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
Center of Hope at Renown Medical Center
Reno, Nevada, 89502, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
UMDNJ - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
Virtua West Jersey Hospital Voorhees
Voorhees Township, New Jersey, 08043, United States
University of New Mexico
Albuquerque, New Mexico, 87102, United States
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, 87106, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, 88011, United States
Women's Cancer Care Associates LLC
Albany, New York, 12208, United States
State University of New York Downstate Medical Center
Brooklyn, New York, 11203, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Carolinas HealthCare System NorthEast
Concord, North Carolina, 28025, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
Lake University Ireland Cancer Center
Mentor, Ohio, 44060, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Tulsa Cancer Institute
Tulsa, Oklahoma, 74146, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
Zale Lipshy University Hospital
Dallas, Texas, 75235, United States
Clements University Hospital
Dallas, Texas, 75390, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, 76104, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Related Publications (2)
Kantidakis G, Litiere S, Neven A, Vinches M, Judson I, Schoffski P, Wardelmann E, Stacchiotti S, D'Ambrosio L, Marreaud S, van der Graaf WTA, Kasper B, Fiocco M, Gelderblom H. Efficacy thresholds for clinical trials with advanced or metastatic leiomyosarcoma patients: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group meta-analysis based on a literature review for soft-tissue sarcomas. Eur J Cancer. 2021 Sep;154:253-268. doi: 10.1016/j.ejca.2021.06.025. Epub 2021 Jul 20.
PMID: 34298376DERIVEDHensley ML, Miller A, O'Malley DM, Mannel RS, Behbakht K, Bakkum-Gamez JN, Michael H. Randomized phase III trial of gemcitabine plus docetaxel plus bevacizumab or placebo as first-line treatment for metastatic uterine leiomyosarcoma: an NRG Oncology/Gynecologic Oncology Group study. J Clin Oncol. 2015 Apr 1;33(10):1180-5. doi: 10.1200/JCO.2014.58.3781. Epub 2015 Feb 23.
PMID: 25713428DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was targeted to accrue 130 patients, but closed early for futility. Early termination leading to small numbers of subjects analyzed.
Results Point of Contact
- Title
- Angela M. Kuras, Associate Director of Administration and Operations
- Organization
- NRG Oncology Statistics and Data Management Center - Buffalo
Study Officials
- PRINCIPAL INVESTIGATOR
Martee Hensley
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2009
First Posted
November 13, 2009
Study Start
November 1, 2009
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
September 2, 2020
Results First Posted
July 14, 2017
Record last verified: 2020-08