Recurrent Uterine Corpus Sarcoma Clinical Trial
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
Verified date | August 2020 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 107 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. - No history of transient ischemic attack (TIA) or stroke or CNS hemorrhage within the past 6 months - Urine protein creatinine (UPC) ratio must be < 1.0 gm; if UPC ratio >= 1, collection of 24-hour urine measurement of urine protein is recommended - PT such that international normalized ratio (INR) is =< 1.5 and a PTT =< 1.5 times the institutional upper limit of normal (or an in-therapeutic-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) - Patients must have signed an approved informed consent and authorization permitting release of personal health information - Patients must meet pre-entry requirements - Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception Exclusion Criteria: - 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 - History of pulmonary embolism or deep vein thrombosis in the past 6 months - Patients with, or with anticipation of, invasive procedures as defined below: - Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab/placebo therapy - Major surgical procedure anticipated during the course of the study. - Minor surgical procedures (i.e., mediport insertion), fine needle aspirates, or core biopsies within 7 days prior to the first date of bevacizumab/placebo therapy - Patients who are pregnant or nursing |
Country | Name | City | State |
---|---|---|---|
United States | Abington Memorial Hospital | Abington | Pennsylvania |
United States | Summa Akron City Hospital/Cooper Cancer Center | Akron | Ohio |
United States | Women's Cancer Care Associates LLC | Albany | New York |
United States | Southwest Gynecologic Oncology Associates Inc | Albuquerque | New Mexico |
United States | University of New Mexico | Albuquerque | New Mexico |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania |
United States | Georgia Regents University Medical Center | Augusta | Georgia |
United States | The Medical Center of Aurora | Aurora | Colorado |
United States | University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora | Colorado |
United States | Greater Baltimore Medical Center | Baltimore | Maryland |
United States | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland |
United States | MedStar Franklin Square Medical Center/Weinberg Cancer Institute | Baltimore | Maryland |
United States | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland |
United States | Bronson Battle Creek | Battle Creek | Michigan |
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
United States | Spectrum Health Big Rapids Hospital | Big Rapids | Michigan |
United States | Boulder Community Hospital | Boulder | Colorado |
United States | State University of New York Downstate Medical Center | Brooklyn | New York |
United States | Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California |
United States | Lahey Hospital and Medical Center | Burlington | Massachusetts |
United States | University of Vermont Medical Center | Burlington | Vermont |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Cooper Hospital University Medical Center | Camden | New Jersey |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina |
United States | Novant Health Presbyterian Medical Center | Charlotte | North Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | MetroHealth Medical Center | Cleveland | Ohio |
United States | Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa |
United States | Mercy Cancer Center-West Lakes | Clive | Iowa |
United States | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado |
United States | John B Amos Cancer Center | Columbus | Georgia |
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | Carolinas HealthCare System NorthEast | Concord | North Carolina |
United States | John Muir Medical Center-Concord Campus | Concord | California |
United States | Mercy Hospital | Coon Rapids | Minnesota |
United States | Clements University Hospital | Dallas | Texas |
United States | Parkland Memorial Hospital | Dallas | Texas |
United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
United States | Zale Lipshy University Hospital | Dallas | Texas |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Colorado Cancer Research Program CCOP | Denver | Colorado |
United States | Exempla Saint Joseph Hospital | Denver | Colorado |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado |
United States | Rose Medical Center | Denver | Colorado |
United States | Iowa Lutheran Hospital | Des Moines | Iowa |
United States | Iowa Methodist Medical Center | Des Moines | Iowa |
United States | Iowa Oncology Research Association CCOP | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa |
United States | Mercy Medical Center - Des Moines | Des Moines | Iowa |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Fairview-Southdale Hospital | Edina | Minnesota |
United States | Elkhart Clinic | Elkhart | Indiana |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Michiana Hematology Oncology PC-Elkhart | Elkhart | Indiana |
United States | Union Hospital of Cecil County | Elkton | Maryland |
United States | Rocky Mountain Gynecologic Oncology PC | Englewood | Colorado |
United States | Swedish Medical Center | Englewood | Colorado |
United States | Baylor All Saints Medical Center at Fort Worth | Fort Worth | Texas |
United States | Unity Hospital | Fridley | Minnesota |
United States | Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado |
United States | Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan |
United States | Mercy Health Saint Mary's | Grand Rapids | Michigan |
United States | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan |
United States | North Colorado Medical Center | Greeley | Colorado |
United States | Hartford Hospital | Hartford | Connecticut |
United States | Geisinger Medical Center-Cancer Center Hazleton | Hazleton | Pennsylvania |
United States | Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania |
United States | Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale | Illinois |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | Hutchinson Area Health Care | Hutchinson | Minnesota |
United States | Franciscan Saint Francis Health-Indianapolis | Indianapolis | Indiana |
United States | Gynecologic Oncology of Indiana | Indianapolis | Indiana |
United States | Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
United States | Saint Vincent Oncology Center | Indianapolis | Indiana |
United States | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | University of Kansas Cancer Center | Kansas City | Kansas |
United States | Kettering Medical Center | Kettering | Ohio |
United States | Community Howard Regional Health | Kokomo | Indiana |
United States | UC San Diego Moores Cancer Center | La Jolla | California |
United States | IU Health La Porte Hospital | La Porte | Indiana |
United States | Saint Anthony Hospital | Lakewood | Colorado |
United States | Memorial Medical Center - Las Cruces | Las Cruces | New Mexico |
United States | Women's Cancer Center of Nevada | Las Vegas | Nevada |
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Beebe Medical Center | Lewes | Delaware |
United States | Baptist Health Lexington | Lexington | Kentucky |
United States | Littleton Adventist Hospital | Littleton | Colorado |
United States | Sky Ridge Medical Center | Lone Tree | Colorado |
United States | Longmont United Hospital | Longmont | Colorado |
United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
United States | Los Angeles County-USC Medical Center | Los Angeles | California |
United States | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California |
United States | USC / Norris Comprehensive Cancer Center | Los Angeles | California |
United States | Norton Hospital Pavilion and Medical Campus | Louisville | Kentucky |
United States | The James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky |
United States | McKee Medical Center | Loveland | Colorado |
United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
United States | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota |
United States | Saint John's Hospital - Healtheast | Maplewood | Minnesota |
United States | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio |
United States | Lake University Ireland Cancer Center | Mentor | Ohio |
United States | Mercy Hospital | Miami | Florida |
United States | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida |
United States | Abbott-Northwestern Hospital | Minneapolis | Minnesota |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Michiana Hematology Oncology PC-Mishawaka | Mishawaka | Indiana |
United States | Saint Joseph Regional Medical Center-Mishawaka | Mishawaka | Indiana |
United States | Morristown Medical Center | Morristown | New Jersey |
United States | Virtua Memorial | Mount Holly | New Jersey |
United States | Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View | California |
United States | Mercy Health Mercy Campus | Muskegon | Michigan |
United States | The Hospital of Central Connecticut | New Britain | Connecticut |
United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | UMDNJ - Robert Wood Johnson University Hospital | New Brunswick | New Jersey |
United States | Cancer Center of Western Wisconsin | New Richmond | Wisconsin |
United States | New Ulm Medical Center | New Ulm | Minnesota |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Mount Sinai Medical Center | New York | New York |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | Michiana Hematology Oncology PC-Niles | Niles | Michigan |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Nebraska Methodist Hospital | Omaha | Nebraska |
United States | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California |
United States | Florida Hospital Orlando | Orlando | Florida |
United States | UF Cancer Center at Orlando Health | Orlando | Florida |
United States | Parker Adventist Hospital | Parker | Colorado |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Pennsylvania Hospital | Philadelphia | Pennsylvania |
United States | Saint Joseph's Hospital and Medical Center | Phoenix | Arizona |
United States | UPMC-Magee Womens Hospital | Pittsburgh | Pennsylvania |
United States | West Penn Hospital | Pittsburgh | Pennsylvania |
United States | Michiana Hematology Oncology PC-Plymouth | Plymouth | Indiana |
United States | Women and Infants Hospital | Providence | Rhode Island |
United States | Saint Mary Corwin Medical Center | Pueblo | Colorado |
United States | Spectrum Health Reed City Hospital | Reed City | Michigan |
United States | Center of Hope at Renown Medical Center | Reno | Nevada |
United States | North Memorial Medical Health Center | Robbinsdale | Minnesota |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Lakeland Hospital | Saint Joseph | Michigan |
United States | Marie Yeager Cancer Center | Saint Joseph | Michigan |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Metro-Minnesota NCI Community Oncology Research Program | Saint Louis Park | Minnesota |
United States | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota |
United States | Regions Hospital | Saint Paul | Minnesota |
United States | United Hospital | Saint Paul | Minnesota |
United States | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah |
United States | University of California San Diego | San Diego | California |
United States | UCSF Medical Center-Mount Zion | San Francisco | California |
United States | Memorial University Medical Center | Savannah | Georgia |
United States | Saint Francis Regional Medical Center | Shakopee | Minnesota |
United States | Avera Cancer Institute | Sioux Falls | South Dakota |
United States | Sanford Cancer Center-Oncology Clinic | Sioux Falls | South Dakota |
United States | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Michiana Hematology Oncology PC-South Bend | South Bend | Indiana |
United States | Northern Indiana Cancer Research Consortium CCOP | South Bend | Indiana |
United States | South Bend Clinic | South Bend | Indiana |
United States | Cancer Research for the Ozarks NCORP | Springfield | Missouri |
United States | CoxHealth South Hospital | Springfield | Missouri |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Mercy Hospital Springfield | Springfield | Missouri |
United States | Geisinger Medical Group | State College | Pennsylvania |
United States | Lakeview Hospital | Stillwater | Minnesota |
United States | Stony Brook University Medical Center | Stony Brook | New York |
United States | Overlook Hospital | Summit | New Jersey |
United States | Olive View-University of California Los Angeles Medical Center | Sylmar | California |
United States | North Suburban Medical Center | Thornton | Colorado |
United States | Munson Medical Center | Traverse City | Michigan |
United States | Tulsa Cancer Institute | Tulsa | Oklahoma |
United States | Virtua West Jersey Hospital Voorhees | Voorhees | New Jersey |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | John Muir Medical Center-Walnut Creek | Walnut Creek | California |
United States | Cadence Cancer Center in Warrenville | Warrenville | Illinois |
United States | Washington Hospital Center | Washington | District of Columbia |
United States | Mercy Medical Center-West Lakes | West Des Moines | Iowa |
United States | Methodist West Hospital | West Des Moines | Iowa |
United States | Reading Hospital | West Reading | Pennsylvania |
United States | Michiana Hematology Oncology PC-Westville | Westville | Indiana |
United States | SCL Health Lutheran Medical Center | Wheat Ridge | Colorado |
United States | Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania |
United States | Rice Memorial Hospital | Willmar | Minnesota |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
United States | Minnesota Oncology and Hematology PA-Woodbury | Woodbury | Minnesota |
United States | Metro Health Hospital | Wyoming | Michigan |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) | NRG Oncology |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Overall Survival | Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last followup were censored on the date of last CT Scan. The product-limit method will be used to estimate the cumulative distribution of overall survival times for the patients assigned to each treatment group. |
Up to 5 years | |
Secondary | Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0 | Count of participants with Adverse events (AEs) that are CTCAE Grade 3 or worse. Please refer to the adverse event reporting for more detail. |
Up to 5 years | |
Secondary | Objective Response Rate as Measured by RECIST 1.1 Criteria | "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Up to 5 years |
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