Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer
Phase II Trial of Brostallicin and Cisplatin in Patients With Metastatic Triple Negative Breast Cancer
4 other identifiers
interventional
48
1 country
266
Brief Summary
This phase II trial studies how well brostallicin and cisplatin work in treating patients with breast cancer that has spread to other parts of the body (metastatic) and does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 (HER2) on its cells (triple-negative). Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from spreading.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2010
Typical duration for phase_2
266 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
First Submitted
Initial submission to the registry
March 18, 2010
CompletedFirst Posted
Study publicly available on registry
March 24, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
March 20, 2017
CompletedMay 8, 2018
April 1, 2018
2 years
March 18, 2010
December 7, 2016
April 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-month Progression-free Survival (3-mo PFS) Rate
A patient is considered to be a 3-month progression-free survivor if the patient is on study treatment 3 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients and 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If some patients are lost to follow-up not having been observed for at least 3 months, an estimate and confidence interval for the 3-month PFS rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
3 months
Secondary Outcomes (5)
Confirmed Response Rate
Up to 5 years
Duration of Response
Up to 5 years
6-month Progression-free Survival (6-mo PFS) Rate
At 6 months
Time to Disease Progression
up to 5 years
Survival Time
Up to 5 years
Study Arms (1)
Treatment (cisplatin and brostallicin)
EXPERIMENTALPatients receive cisplatin IV over 2 hours on day 1 and brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed adenocarcinoma of the breast with clinical evidence of metastatic disease
- Triple negative breast cancer defined as HER2-(according to current American Society of Clinical Oncology \[ASCO\] College of American Pathologists \[CAP\] guidelines), ER- (defined as =\< 1% by IHC) and PgR- (defined as =\< 1% by IHC)
- to 4 prior chemotherapy regimens in the metastatic setting
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
- Hemoglobin \>= 10.0 g/dL
- Absolute neutrophil count (ANC) \>= 1500/mm\^3
- Platelet count \>= 100,000/mL
- Total bilirubin =\< 1.5 x upper limit of normal (ULN)
- Serum creatinine =\< 1.5 mg/dL
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 3 x ULN or SGOT (AST) and SGPT (ALT) =\< 5 x ULN if elevations are due to liver metastases
- Alkaline phosphatase =\< 2.5 x ULN or alkaline phosphatase =\< 5 x ULN if elevations are due to liver metastases
- Electrocardiogram (EKG) completed =\< 15 days prior to registration
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
- Life expectancy \> 3 months
- +3 more criteria
You may not qualify if:
- HER2 positive (3+ by IHC or fluorescence in situ hybridization \[FISH\] amplified) breast cancer by ASCO/CAP guidelines
- Estrogen receptor (ER) and/or progesterone receptor (PR/PgR) positive breast cancer (defined as \> 1% of either receptor by IHC)
- Any of the following
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician) while on this study and for 30 days after end of treatment with the study drugs
- Stage III or IV invasive non-breast malignancy in =\< 5 years prior to registration
- Pre-existing peripheral neuropathy of grade \>= 2 (using the CTEP active version of the CTCAE)
- Major surgery =\< 4 weeks prior to registration
- Chemotherapy or immunologic therapy =\< 3 weeks prior to registration
- Radiotherapy =\< 2 weeks prior to registration, except if to a non-target lesion only
- \* NOTES:
- Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed
- If patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting 2 weeks
- Acute adverse events from radiation must have resolved to =\< grade 1 (according to the CTEP active version of the CTCAE)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (266)
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499, United States
Aurora Presbyterian Hospital
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301-9019, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, 80933, United States
St. Anthony Central Hospital
Denver, Colorado, 80204, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver, Colorado, 80218, United States
St. Joseph Hospital
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
CCOP - Colorado Cancer Research Program
Denver, Colorado, 80224-2522, United States
Swedish Medical Center
Englewood, Colorado, 80110, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Front Range Cancer Specialists
Fort Collins, Colorado, 80528, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, 81502, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, 80501, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813, United States
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, 96813, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, 96813, United States
Hawaii Medical Center - East
Honolulu, Hawaii, 96817, United States
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
Maui Memorial Medical Center
Wailuku, Hawaii, 96793, United States
Kapiolani Medical Center at Pali Momi
‘Aiea, Hawaii, 96701, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, 60504, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, 61701, United States
St. Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital
Canton, Illinois, 61520, United States
Illinois CancerCare - Canton
Canton, Illinois, 61520, United States
Illinois CancerCare - Carthage
Carthage, Illinois, 62321, United States
Eureka Community Hospital
Eureka, Illinois, 61530, United States
Illinois CancerCare - Eureka
Eureka, Illinois, 61530, United States
Galesburg Clinic, PC
Galesburg, Illinois, 61401, United States
Illinois CancerCare - Galesburg
Galesburg, Illinois, 61401, United States
Illinois CancerCare - Havana
Havana, Illinois, 62644, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, 61443, United States
Illinois CancerCare - Macomb
Macomb, Illinois, 61455, United States
McDonough District Hospital
Macomb, Illinois, 61455, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, 61265, United States
Unknown Facility
Moline, Illinois, 61265, United States
Illinois CancerCare - Monmouth
Monmouth, Illinois, 61462, United States
OSF Holy Family Medical Center
Monmouth, Illinois, 61462, United States
BroMenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Illinois CancerCare - Community Cancer Center
Normal, Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa, Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare - Peru
Peru, Illinois, 61354, United States
Illinois Valley Community Hospital
Peru, Illinois, 61354, United States
Illinois CancerCare - Princeton
Princeton, Illinois, 61356, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, 46107, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360, United States
Reid Hospital & Health Care Services
Richmond, Indiana, 47374, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
Unknown Facility
Bettendorf, Iowa, 52722, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, 52403, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, 52403, 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
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51102, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 49221, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, 49017, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123-2500, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, 49503, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, 49503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801, United States
Foote Memorial Hospital
Jackson, Michigan, 49201, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48912-1811, United States
St. Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Community Cancer Center of Monroe
Monroe, Michigan, 48162, United States
Mercy Memorial Hospital - Monroe
Monroe, Michigan, 48162, United States
Mercy General Health Partners
Muskegon, Michigan, 49443, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, 48601, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
St. John Macomb Hospital
Warren, Michigan, 48093, United States
Unknown Facility
Alexandria, Minnesota, 56308, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, 55805-1983, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
Miller - Dwan Medical Center
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, 55109, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, 56303, United States
Coborn Cancer Center
Saint Cloud, Minnesota, 56303, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, 55125, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
Goldschmidt Cancer Center
Jefferson City, Missouri, 65109, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802, United States
St. John's Regional Health Center
Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
Missouri Baptist Cancer Center
St Louis, Missouri, 63131, United States
Comprehensive Cancer Care, PC
St Louis, Missouri, 63141, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59102, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
St. James Healthcare Cancer Care
Butte, Montana, 59701, United States
Big Sky Oncology
Great Falls, Montana, 59405-5309, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, 59405, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
St. Peter's Hospital
Helena, Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Lakeside Hospital
Omaha, Nebraska, 68130, United States
Creighton University Medical Center
Omaha, Nebraska, 68131-2197, United States
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-5636, United States
Bismarck Cancer Center
Bismarck, North Dakota, 58501, United States
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, 58501, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, 58501, United States
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, 58502, United States
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, 58201, United States
Wood County Oncology Center
Bowling Green, Ohio, 43402, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998, United States
CCOP - Columbus
Columbus, Ohio, 43215, United States
Grant Medical Center Cancer Care
Columbus, Ohio, 43215, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, 43228, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital
Dayton, Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton, Ohio, 45415, United States
CCOP - Dayton
Dayton, Ohio, 45420, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Community Cancer Center
Elyria, Ohio, 44035, United States
Hematology Oncology Center
Elyria, Ohio, 44035, United States
Blanchard Valley Medical Associates
Findlay, Ohio, 45840, United States
Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Northwest Ohio Oncology Center
Maumee, Ohio, 43537-1839, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, 43055, United States
Fisher-Titus Medical Center
Norwalk, Ohio, 44857, United States
St. Charles Mercy Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic - Oregon
Oregon, Ohio, 43616, United States
Southern Ohio Medical Center Cancer Center
Portsmouth, Ohio, 45662, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, 45505, United States
Flower Hospital Cancer Center
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43617, United States
St. Anne Mercy Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, 43623, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373-1300, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, 43081, United States
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Air Force Base, Ohio, 45433-5529, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, 43701, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, 17822-0001, United States
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, 18201, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, 16801, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, 57117-5039, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, 22401, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298-0037, United States
Marshfield Clinic - Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
Eau Claire, Wisconsin, 54701, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, 54701, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, 54221-1450, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, 54548, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, 54501, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, 54868, United States
St. Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Marshfield Clinic at Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, 82801, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alvaro Moreno-Aspitia MD
- Organization
- Mayo Clinic
Study Officials
- STUDY CHAIR
Alvaro Moreno Aspitia, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2010
First Posted
March 24, 2010
Study Start
June 1, 2010
Primary Completion
June 1, 2012
Study Completion
November 1, 2014
Last Updated
May 8, 2018
Results First Posted
March 20, 2017
Record last verified: 2018-04