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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01012297
Other study ID # NCI-2010-01738
Secondary ID NCI-2010-01738CD
Status Terminated
Phase Phase 3
First received
Last updated
Start date November 2009
Est. completion date September 2015

Study information

Verified date August 2020
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

PRIMARY OBJECTIVES:

I. To determine whether the addition of bevacizumab to fixed-dose rate gemcitabine-docetaxel reduces the progression-free survival (PFS) event rate when compared to gemcitabine-docetaxel plus placebo in patients with advanced or recurrent uterine leiomyosarcoma (LMS).

SECONDARY OBJECTIVES:

I. To determine the objective response rate, as measured by RECIST, of patients treated with fixed-dose rate gemcitabine-docetaxel with bevacizumab, compared with the objective response rate of patients treated with fixed-dose rate gemcitabine-docetaxel with placebo.

II. To determine if the addition of bevacizumab to the combination of gemcitabine and docetaxel increases overall survival in patients with advanced or recurrent uterine LMS.

III. To determine the toxicity profile of fixed-dose rate gemcitabine-docetaxel with and without bevacizumab in this patient population.

IV. To bank formalin-fixed and paraffin-embedded (FFPE) tumor tissue for research.

OUTLINE: This is a multicenter study. Patients are stratified according to prior whole-pelvic radiotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients 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: Patients 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.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.


Recruitment information / eligibility

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

Study Design


Intervention

Biological:
Bevacizumab
Given IV
Drug:
Docetaxel
Given IV
Biological:
Filgrastim
Given SC
Drug:
Gemcitabine Hydrochloride
Given IV
Biological:
Pegfilgrastim
Given SC
Other:
Placebo
Given IV

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
National Cancer Institute (NCI) NRG Oncology

Country where clinical trial is conducted

United States, 

Outcome

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
See also
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Completed NCT01637961 - Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Phase 2