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Alisertib in Treating Patients With Advanced or Metastatic Sarcoma

This study has suspended participant recruitment.
(Temporarily stopped for assessment)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01653028
First received: July 26, 2012
Last updated: August 13, 2014
Last verified: March 2014
  Purpose

This phase II trial studies how well alisertib works in treating patients with advanced or metastatic sarcoma. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Condition Intervention Phase
Adult Alveolar Soft-part Sarcoma
Adult Angiosarcoma
Adult Epithelioid Sarcoma
Adult Extraskeletal Chondrosarcoma
Adult Fibrosarcoma
Adult Leiomyosarcoma
Adult Liposarcoma
Adult Neurofibrosarcoma
Chondrosarcoma
Endometrial Stromal Sarcoma
Mast Cell Sarcoma
Metastatic Adult Malignant Fibrous Histiocytoma of Bone
Ovarian Carcinosarcoma
Ovarian Sarcoma
Recurrent Adult Malignant Fibrous Histiocytoma of Bone
Recurrent Adult Soft Tissue Sarcoma
Small Intestine Leiomyosarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Drug: alisertib
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of MLN8237 in Advanced / Metastatic Sarcoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • The confirmed response rate (CR/PR) [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    The overall response rate (CR + PR) will be estimated and a 90% confidence interval provided.


Secondary Outcome Measures:
  • PFS [ Time Frame: The time between registration to disease progression or death, assessed up to 18 months ] [ Designated as safety issue: No ]
    The distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS at specific time points will be calculated (eg, median, 1 year PFS).

  • OS [ Time Frame: The time between registration and death, assessed up to 18 months ] [ Designated as safety issue: No ]
    The distribution will be estimated by the methods of Kaplan and Meier. The estimates of survival at specific time points will be calculated (eg, median, 6 month survival).

  • Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
    Adverse events will be summarized using summary statistics and frequency tables for each separate cohort. Analyses will be descriptive in nature.


Other Outcome Measures:
  • Biopsy protein levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    For tumor biopsies, pre- and post-treatment protein levels will be compared by Wilcoxon signed-rank test (for paired samples). The association of response or clinical benefit with the presence or absence of markers of pathway inhibition in patient tumors will be tested using Fisher's exact test.

  • Biopsy protein levels [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    For tumor biopsies, pre- and post-treatment protein levels will be compared by Wilcoxon signed-rank test (for paired samples). The association of response or clinical benefit with the presence or absence of markers of pathway inhibition in patient tumors will be tested using Fisher's exact test.

  • Changes in FLT-PET uptake [ Time Frame: Baseline to 1 week ] [ Designated as safety issue: No ]
    Changes in FLT-PET uptake at baseline versus after one week of treatment will be compared by Wilcoxon Rank Sum test between responders and non-responders defined by RECIST criteria. Fisher's exact test will be used to assess the association between dichotomous change in FLT-PET uptake change and RECIST response status.


Estimated Enrollment: 135
Study Start Date: August 2012
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (alisertib)
Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: alisertib
Given PO
Other Names:
  • Aurora A kinase inhibitor MLN8237
  • MLN8237
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the response rate (complete response [CR] + partial response [PR]) assessed for patients within each cohort: liposarcoma (cohort 1); leiomyosarcoma (non-uterine) (cohort 2); undifferentiated sarcoma (including pleomorphic undifferentiated sarcoma, formerly known as malignant fibrous histiocytoma, and myxofibrosarcoma) (cohort 3); malignant peripheral nerve sheath tumor (cohort 4); and other sarcomas (cohort 5).

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) and overall survival (OS) for patients treated with alisertib (MLN8237) in each cohort.

II. To assess the adverse events associated with patients treated with MLN8237 in each cohort.

TERTIARY OBJECTIVES:

I. To correlate potential clinical benefit with markers of aurora kinase inhibition in pre- and post-treatment tumor biopsies.

II. To correlate clinical outcome with change in fluorine F 18 fluorothymidine (FLT)-positron emission tomography (PET) uptake at baseline versus after one week of treatment (i.e., week 2 of cycle 1).

OUTLINE:

Patients receive alisertib orally (PO) twice daily (BID) on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed sarcoma that is metastatic and/or locally advanced or locally recurrent and unresectable; confirmation of pathologic diagnosis will be performed at the registering site; patients will been rolled on one of five cohorts of the study:

    • Cohort 1: liposarcoma
    • Cohort 2: leiomyosarcoma (non-uterine)
    • Cohort 3: undifferentiated sarcoma (including malignant fibrous histiocytoma and myxofibrosarcoma)
    • Cohort 4: malignant peripheral nerve sheath tumor
    • Cohort 5: other sarcomas
  • Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST) 1.1; note: defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
  • Any number of prior therapies is permitted; note: the last dose of systemic therapy (including tyrosine kinase inhibitors) must have been given >= 4 weeks prior to initiation of study therapy; patients receiving BCNU or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelet count >= 100,000/mcL
  • Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (alanine aminotransferase [AST]) < 3 times ULN if no liver metastases or < 5 times ULN if liver metastases present
  • Creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min/1.73m^2 for patients with creatinine levels above institutional normal
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of MLN8237 administration
  • Ability to understand and the willingness to sign a written informed consent document
  • According to current guidelines, patients must be able to take oral medication and to maintain a fast as required for approximately one hour before and two hours after MLN8237 administration

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have had radiation therapy to more than 25% of the bone marrow; whole pelvic radiation is considered to be over 25%
  • Patients who are receiving any other investigational agents
  • Patients with known brain metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237 including, but not limited to, established allergic reaction to benzodiazepines
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, New York Heart Association (NYHA) class II-IV heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women; women of child-bearing potential must have a negative serum or urine pregnancy test within 7 days prior to registration; breastfeeding should be discontinued if the mother is treated with MLN8237
  • Leiomyosarcoma of the uterus
  • Patients known to be human immunodeficiency virus (HIV)-positive on antiretroviral therapy
  • Prior allogeneic bone marrow or organ transplantation
  • Known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease, requirement for supplemental oxygen, or any conditions that could result in excessive toxicity associated with the benzodiazepine-like effects of MLN8237
  • Requirement for constant administration of proton pump inhibitor, histamine-2 (H2) antagonist, or pancreatic enzymes; note: intermittent uses of antacids or H2 antagonists are allowed
  • Inability to swallow oral medication or to maintain a required fast for approximately one hour before and two hours after MLN8237 administration or any condition that would modify small bowel absorption of oral medications, including malabsorption or resection of pancreas or upper bowel
  • Treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine, oxcarbazepine, primidone or phenobarbital, or rifampin, rifabutin, rifapentine, or St. John's wort within 14 days prior to the first dose of MLN8237 and during the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653028

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States, 80304
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States, 80218
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States, 80220
Rose Medical Center
Denver, Colorado, United States, 80220
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80907
Mercy Medical Center
Durango, Colorado, United States, 81301
Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado, United States, 80113
Swedish Medical Center
Englewood, Colorado, United States, 80113
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Mountain Blue Cancer Care Center
Golden, Colorado, United States, 80401
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Breast Cancer Care Consultants
Greenwood Village, Colorado, United States, 80111
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States, 80228
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States, 80124
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States, 80501
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Parker Adventist Hospital
Parker, Colorado, United States, 80138
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, United States, 80138
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, United States, 81008
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
United States, Georgia
John B Amos Cancer Center
Columbus, Georgia, United States, 31904
United States, Hawaii
Oncare Hawaii Inc-Pali Momi
Aiea, Hawaii, United States, 96701
Pali Momi Medical Center
Aiea, Hawaii, United States, 96701
University of Hawaii
Honolulu, Hawaii, United States, 96813
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, United States, 96817
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States, 96813
OnCare Hawaii-Liliha
Honolulu, Hawaii, United States, 96817-3169
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
Castle Medical Center
Kailua, Hawaii, United States, 96734
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
United States, Idaho
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, United States, 61265
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, United States, 61265
Spector, David MD (UIA Investigator)
Moline, Illinois, United States, 61265
Trinity Medical Center
Moline, Illinois, United States, 61265
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Franciscan Saint Francis Health-Indianapolis
Indianapolis, Indiana, United States, 46237
Reid Hospital and Health Care Services
Richmond, Indiana, United States, 47374
United States, Iowa
Mary Greeley Medical Center
Ames, Iowa, United States, 50010
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, United States, 52722
McFarland Clinic PC-Boone
Boone, Iowa, United States, 50036
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
McFarland Clinic PC-Jefferson
Jefferson, Iowa, United States, 50129
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa, United States, 50158
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States, 50266
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, United States, 66502
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Associates In Womens Health
Wichita, Kansas, United States, 67208
Wichita CCOP
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Oncology Hematology Care Incorporated
Crestview Hills, Kentucky, United States, 41017
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Bixby Medical Center
Adrian, Michigan, United States, 49221
Hickman Cancer Center
Adrian, Michigan, United States, 49221
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49431
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy Memorial Hospital
Monroe, Michigan, United States, 48162
United States, Minnesota
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Centerpoint Medical Center LLC
Independence, Missouri, United States, 64057
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Hospital
Liberty, Missouri, United States, 64068
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States, 64507
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Montana
Billings Clinic
Billings, Montana, United States, 59107-7000
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
United States, Nebraska
Saint Francis Medical Center
Grand Island, Nebraska, United States, 68803
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan Kettering Cancer Center Commack
Commack, New York, United States, 11725
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan-Kettering Cancer Center Rockville Centre
Rockville Centre, New York, United States, 11570
Memorial Sloan-Kettering Cancer Center at Sleepy Hallow
Sleepy Hollow, New York, United States, 10591
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
Southeast Cancer Control Consortium CCOP
Winston-Salem, North Carolina, United States, 27104
United States, North Dakota
Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Sanford Clinic North-Fargo
Fargo, North Dakota, United States, 58122
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States, 43402
Oncology Hematology Care Inc - Kenwood
Cincinnati, Ohio, United States, 45236
Oncology and Hematology Care Incorporated
Cincinnati, Ohio, United States, 45219
Oncology Hematology Care Inc - Anderson
Cincinnati, Ohio, United States, 45230
Oncology Hematology Care Inc - Western Hills
Cincinnati, Ohio, United States, 45248
Oncology and Hematology Care Inc - Blue Ash
Cincinnati, Ohio, United States, 45242
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Dayton CCOP
Dayton, Ohio, United States, 45420
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Grandview Hospital
Dayton, Ohio, United States, 45405
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Hematology Oncology Center Incorporated
Elyria, Ohio, United States, 44035
Mercy Cancer Center-Elyria
Elyria, Ohio, United States, 44035
Oncology Hematology Care Inc
Fairfield, Ohio, United States, 45014
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Kettering Medical Center
Kettering, Ohio, United States, 45429
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States, 43537
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States, 43537
Saint Charles Hospital
Oregon, Ohio, United States, 43616
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States, 43616
Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States, 43617
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States, 43623
Mercy Saint Anne Hospital
Toledo, Ohio, United States, 43623
University of Toledo
Toledo, Ohio, United States, 43614
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Wright-Patterson Medical Center
Wright-Patterson Afb, Ohio, United States, 45433-5529
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States, 74136
Oklahoma Oncology Inc
Tulsa, Oklahoma, United States, 74104
Warren Cancer Research Foundation
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
Geisinger Medical Oncology at Evangelical Community Hospital
Lewisburg, Pennsylvania, United States, 17837
Geisinger Medical Oncology-Pottsville
Pottsville, Pennsylvania, United States, 17901
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506
United States, South Dakota
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
United States, Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont, United States, 05602
University of Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States, 22401
United States, Wisconsin
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Saint Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Investigators
Principal Investigator: Mark Dickson Alliance for Clinical Trials in Oncology
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01653028     History of Changes
Other Study ID Numbers: NCI-2012-01991, NCI-2012-01991, CDR0000737403, CALGB-A091102, A091102, A091102, U10CA031946, U10CA180821
Study First Received: July 26, 2012
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinosarcoma
Chondrosarcoma
Fibrosarcoma
Hemangiosarcoma
Histiocytoma
Histiocytoma, Benign Fibrous
Histiocytoma, Malignant Fibrous
Leiomyosarcoma
Liposarcoma
Mast-Cell Sarcoma
Mixed Tumor, Mullerian
Neurofibrosarcoma
Ovarian Neoplasms
Sarcoma
Sarcoma, Alveolar Soft Part
Sarcoma, Endometrial Stromal
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Endometrial Neoplasms
Endometrial Stromal Tumors
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Mastocytosis
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Adipose Tissue
Neoplasms, Complex and Mixed

ClinicalTrials.gov processed this record on November 27, 2014