ClinicalTrials.gov
ClinicalTrials.gov Menu

Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00699491
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : May 21, 2015
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase I/II trial is studying the side effects and best dose of cixutumumab when given together with temsirolimus and to see how well they work in treating patients with breast cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other places in the body. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways by targeting certain cells. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may be a better treatment for breast cancer.

Condition or disease Intervention/treatment Phase
Male Breast Carcinoma Recurrent Breast Carcinoma Stage IV Breast Cancer AJCC v6 and v7 Biological: Cixutumumab Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Temsirolimus Phase 1 Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To establish the recommended dose level for the phase II trial. (Phase I) II. To examine the safety profile of this combination in patients with metastatic breast cancer. (Phase I) III. To assess the anti-tumor activity (in terms of overall response rate) and toxicity profile of IMC-A12 (cixutumumab) in combination with temsirolimus in patients with metastatic breast cancer. (Phase II)

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) and overall survival distributions (as well as the 6-month PFS rate).

II. To evaluate the in vivo mechanisms of action of temsirolimus in combination with IMC-A12 and to examine potential biomarker predictors of treatment response.

OUTLINE: This is a phase I, dose-escalation study of cixutumumab followed by a phase II study.

Patients receive temsirolimus intravenously (IV) over 30 minutes and cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 (cixutumumab is given on days 8, 15, and 22 of course 1 only). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for up to 2 (phase I) or 5 (phase II) years.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of IMC-A12 in Combination With Temsirolimus in Patients With Metastatic Breast Cancer
Actual Study Start Date : October 31, 2008
Actual Primary Completion Date : September 9, 2013
Actual Study Completion Date : February 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Treatment (cixutumumab, temsirolimus)
Patients receive temsirolimus IV over 30 minutes and cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 (cixutumumab is given on days 8, 15, and 22 of course 1 only). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biological: Cixutumumab
Given IV
Other Names:
  • Anti-IGF-1R Recombinant Monoclonal Antibody IMC-A12
  • IMC-A12

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Pharmacological Study
Correlative studies

Drug: Temsirolimus
Given IV
Other Names:
  • CCI-779
  • CCI-779 Rapamycin Analog
  • Cell Cycle Inhibitor 779
  • Rapamycin Analog
  • Rapamycin Analog CCI-779
  • Torisel




Primary Outcome Measures :
  1. Recommended Dose Level for Phase II Testing (RPTD) (Phase I) [ Time Frame: During first course ]

    The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported.

    Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria:

    • Any grade 4 hematologic toxicity
    • Hyperglycemia that cannot be stably controlled with diabetic medication
    • Any grade 3 or 4 non-hematologic toxicity (except asymptomatic medically manageable laboratory abnormalities such as hyperlipidemia, hypophosphatemia, and hypokalemia)

  2. Tumor Response Rate (TRR) (Complete Response [CR] or Partial Response [PR]) by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II) [ Time Frame: Up to 5 years ]

    A response is defined as a disease burden that meets the RECIST criteria for Complete Response (CR) or Partial Response (PR) on 2 consecutive evaluations at least 6-8 weeks apart.

    Complete Response (CR): All of the following must be true:

    1. Disappearance of all target and non-target lesions.
    2. Each target lymph node must have reduction in short axis to <1.0 cm.

    Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline measures.

    The rate is calculated by dividing the number of patients with a CR or PR by the number of evaluable patients. A ninety percent confidence interval for the true tumor response rate will be calculated using the Duffy-Santer approach.



Secondary Outcome Measures :
  1. Adverse Events Graded Using the NCI CTCAE Version. 3 (Phase II) [ Time Frame: Up to 5 years ]
    Adverse events will be graded using the NCI-CTCAE v3.0 coding scheme. The maximum grade for each adverse event considered to be 'at least possibly related to treatment' will be recorded. Frequency tables will be constructed and the number of patients reporting an adverse event of grade 3 or higher at least possibly related to treatment will be reported.

  2. Duration of Response (Phase II) [ Time Frame: Up to 5 years ]
    Duration of response is defined for all evaluable patients with changes in disease burden that met the RECIST criteria for CR or PR on 2 consecutive evaluations at least 6-8 weeks apart as the date at which the CR or PR to the date progression is documented. The distribution of response durations will be estimated using the Kaplan-Meier method.

  3. Progression Free Survival (PFS) (Phase II) [ Time Frame: Time from registration to documentation of disease progression, up to 5 years ]
    Progression free survival is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on the last day of therapy was administered. The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.The distribution of PFS times will be estimated using the Kaplan-Meier method.

  4. Progression Free Survival Rate [ Time Frame: At 6 months ]
    Progression free survival (PFS) is defined as the time from registration to documentation of disease progression. A point and interval estimate of the 6 month PFS rate will be obtained using the Kaplan-Meier method.

  5. Survival Time (Phase II) [ Time Frame: Time from registration to death due to any cause ]
    Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of breast cancer with diagnosis of metastatic or locally recurrent disease (locally recurrent disease should be stage IV e.g. chest wall involvement)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 (Karnofsky >= 80%)
  • Life expectancy of > 12 weeks
  • Capable of understanding investigational nature, potential risks and benefits of the study and able to provide written informed consent
  • Negative serum pregnancy test =< 7 days of registration for women of childbearing potential:

    • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study therapy and for 3 months after the last dose of IMC-A12 and CCI-779 (temsirolimus)
    • Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
    • Nursing women must be willing to discontinue nursing; NOTE: breastfeeding should be discontinued if the mother is treated with CCI-779 and IMC-A12
  • Absolute neutrophil count >= 1,500/mcL
  • Hemoglobin >= 8.5 g/dL
  • Platelets >= 100,000/mcL
  • Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN (=< 5 X institutional ULN if liver function test [LFT] elevations due to liver metastases)
  • Creatinine =< 1.5 X institutional ULN OR creatinine clearance >= 60 mL/min/1.73^2 for patients with creatinine > institutional ULN
  • Fasting serum cholesterol =< 350 mg/dL (9.0 mmol/L)
  • Fasting triglycerides =< 400 mg/dL (4.56 mmol/L)
  • Albumin >= 3.4 mg/dL
  • Fasting or non fasting serum glucose < 120 mg/dL
  • Hemoglobin A1c (HbA1c) (for all patients with a history of diabetes mellitus) < 8%
  • Phase I only: Any number of prior therapy regimens is allowed
  • Phase II only: Measurable disease is required for the Phase II portion of the study; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques (computed tomography [CT], magnetic resonance imaging [MRI], x-ray) or as >= 10 mm with spiral CT scan
  • Phase II only: =< two and at least one prior chemotherapy regimens in the setting of metastatic or locally recurrent (stage IV chest wall involvement) disease are required

Exclusion Criteria:

  • Phase I patients only: Patients with base line diabetes requiring oral hypoglycemics or insulin
  • Phase II patients only: Poorly controlled diabetes mellitus; NOTE: patients with a history of diabetes mellitus on oral hypoglycemics or insulin are allowed to participate, provided that their fasting blood glucose is < 120 mg/dL and that they are on a stable dietary or therapeutic regimen for this condition
  • Any of the following:

    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception (hormonal agents are not allowed and oral contraceptives are not acceptable for contraception)
  • Receiving hormonal agents used for the treatment of breast cancer with the exception that premenopausal women who have been on a gonadotropin-releasing hormone (GnRH) agonist and subsequently progressed may, at the discretion of the treating physician, continue on the GnRH agonist
  • Any of the following prior therapies:

    • Systemic anti-cancer therapy =< 3 weeks prior to registration
    • Radiation therapy =< 2 weeks prior to registration
  • Prior invasive non-breast malignancy, except for adequately treated basal or squamous cell carcinoma of the skin or other cancer from which the patient has been disease free for >= 5 years
  • Known hypersensitivity reactions to macrolide antibiotics (such as erythromycin, clarithromycin, and azithromycin); allergic reactions attributed to compounds of similar chemical or biologic composition to IMC-A12, or temsirolimus
  • Prior treatment with agents targeting the insulin-like growth factor-I receptor (IGF-IR)/insulin-like growth factors (IGFs) or phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PI3K)/v-akt murine thymoma viral oncogene homolog 1 (Akt)/mechanistic target of rapamycin (mTOR) pathway
  • Receiving any other investigational agents or herbal preparations
  • Patients may not be taking oral corticosteroids except for replacement for adrenal insufficiency
  • Uncontrolled brain metastases; Note: brain metastases are not permitted on study unless the metastases have been treated by surgery or radiotherapy, and the patient has been neurologically stable and off of steroids for >= 12 weeks
  • Known human immunodeficiency virus (HIV)-positive patients who have cluster of differentiation (CD)4 counts below the normal range or who are on anti-retroviral therapy that may interfere with the metabolism of temsirolimus
  • Uncontrolled intercurrent illness including, but not limited to:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Uncontrolled symptomatic cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements
  • Receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital) or any other cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer such as rifampin or St. John's wort

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699491


  Hide Study Locations
Locations
United States, California
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States, 94301
Valley Medical Oncology Consultants
Pleasanton, California, United States, 94588
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
SCL Health Saint Joseph Hospital
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
Colorado Cancer Research Program NCORP
Denver, Colorado, United States, 80222
Swedish Medical Center
Englewood, Colorado, United States, 80113
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
Florida Hospital Orlando
Orlando, Florida, United States, 32803
United States, Georgia
John B Amos Cancer Center
Columbus, Georgia, United States, 31904
United States, Hawaii
Hawaii Oncology Inc-Pali Momi
'Aiea, Hawaii, United States, 96701
Pali Momi Medical Center
'Aiea, Hawaii, United States, 96701
Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii, United States, 96813
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
Hawaii Oncology Inc-Kuakini
Honolulu, Hawaii, United States, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Castle Medical Center
Kailua, Hawaii, United States, 96734
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Graham Hospital Association
Canton, Illinois, United States, 61520
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Memorial Hospital
Carthage, Illinois, United States, 62321
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Heartland Cancer Research NCORP
Decatur, Illinois, United States, 62526
Eureka Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Illinois CancerCare-Havana
Havana, Illinois, United States, 62644
Mason District Hospital
Havana, Illinois, United States, 62644
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Holy Family Medical Center
Monmouth, Illinois, United States, 61462
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States, 61462
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States, 61761
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States, 61362
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Franciscan Health Indianapolis
Indianapolis, Indiana, United States, 46237
Reid Health
Richmond, Indiana, United States, 47374
United States, Iowa
Siouxland Regional Cancer Center
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
United States, Kansas
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, United States, 66208
United States, Maryland
Union Hospital of Cecil County
Elkton, Maryland, United States, 21921
United States, Michigan
Bixby Medical Center
Adrian, Michigan, United States, 49221
Hickman Cancer Center
Adrian, Michigan, United States, 49221
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
Beaumont Hospital-Dearborn
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49829
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Memorial Hospital
Monroe, Michigan, United States, 48162
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, United States, 48162
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341
Lake Huron Medical Center
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Mayo Clinic
Rochester, Minnesota, United States, 55905
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
United States, Missouri
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States, 64507
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Montana
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
United States, Nebraska
Nebraska Cancer Research Center
Lincoln, Nebraska, United States, 68510
Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States, 68130
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, New York
Glens Falls Hospital
Glens Falls, New York, United States, 12801
United States, North Carolina
Randolph Hospital
Asheboro, North Carolina, United States, 27203
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Cone Health Cancer Center
Greensboro, North Carolina, United States, 27403
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States, 27320
United States, North Dakota
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
Saint Alexius Medical Center
Bismarck, North Dakota, United States, 58501
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States, 43402
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Columbus NCI Community Oncology Research Program
Columbus, Ohio, United States, 43215
Grant Medical Center
Columbus, Ohio, United States, 43215
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Doctors Hospital
Columbus, Ohio, United States, 43228
Grandview Hospital
Dayton, Ohio, United States, 45405
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Dayton NCI Community Oncology Research Program
Dayton, Ohio, United States, 45420
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Hematology Oncology Center Incorporated
Elyria, Ohio, United States, 44035
Mercy Cancer Center-Elyria
Elyria, Ohio, United States, 44035
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
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States, 43537
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States, 43537
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Saint Charles Hospital
Oregon, Ohio, United States, 43616
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States, 43616
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
University of Toledo
Toledo, Ohio, United States, 43614
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States, 43617
Mercy Saint Anne Hospital
Toledo, Ohio, United States, 43623
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States, 43623
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States, 43701
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
United States, Oregon
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Virginia
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States, 22401
United States, Washington
Legacy Salmon Creek Hospital
Vancouver, Washington, United States, 98686
United States, Wisconsin
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States, 54303
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Cynthia Ma Alliance for Clinical Trials in Oncology

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00699491     History of Changes
Other Study ID Numbers: NCI-2009-00284
NCI-2009-00284 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000598057
MC0736 ( Other Identifier: Alliance for Clinical Trials in Oncology )
8129 ( Other Identifier: CTEP )
N01CM00071 ( U.S. NIH Grant/Contract )
N01CM00099 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62205 ( U.S. NIH Grant/Contract )
N01CM62207 ( U.S. NIH Grant/Contract )
N01CM62209 ( U.S. NIH Grant/Contract )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA025224 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2008    Key Record Dates
Results First Posted: May 21, 2015
Last Update Posted: June 13, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Breast Neoplasms, Male
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents