Intensity-Modulated Radiation Therapy and Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Anaplastic Thyroid Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01236547
First received: November 5, 2010
Last updated: August 15, 2016
Last verified: April 2016
  Purpose
This randomized phase II trial studies the side effects and how well intensity-modulated radiation therapy (IMRT) and paclitaxel with or without pazopanib hydrochloride works in treating patients with anaplastic thyroid cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and paclitaxel are more effective when given with pazopanib hydrochloride in treating thyroid cancer.

Condition Intervention Phase
Thyroid Gland Undifferentiated (Anaplastic) Carcinoma
Radiation: Intensity-Modulated Radiation Therapy
Drug: Paclitaxel
Drug: Pazopanib Hydrochloride
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Concurrent Intensity Modulated Radiation Therapy (IMRT), Paclitaxel and Pazopanib (NSC 737754)/Placebo, for the Treatment of Anaplastic Thyroid Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Discontinuation of treatment due to toxicity, grade 4 (CTCAE v. 4.0) hemorrhage, grade 4 febrile neutropenia, or any grade 5 adverse event that is assessed to be definitely, probably, or possibly related to the induction or concurrent treatment [ Time Frame: Up to 8 years ] [ Designated as safety issue: Yes ]
  • Overall survival (Phase II) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method. The distributions of the overall survival times will be compared between treatment arms with a one sided log rank test.


Secondary Outcome Measures:
  • Grade 4 (CTCAE, v. 4.0) hemorrhage, grade 4 febrile neutropenia, discontinuation of treatment due to toxicity, or any grade 5 adverse event (Phase II) [ Time Frame: Up to 8 years ] [ Designated as safety issue: Yes ]
    Only adverse events (AEs) assessed to be definitely, probably, or possibly related to protocol treatment will be considered. The rates of adverse events, discontinuation of treatment, and response will be estimated using a binomial distribution along with their associated 95% confidence intervals and will be compared using Fisher's exact test.

  • Local-regional control (Phase II) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Estimated by the cumulative incidence method at 6 and 12 months.

  • Other adverse events (CTCAE, v. 4.0) assessed to be definitely, probably, or possibly related to adjuvant paclitaxel or pazopanib/placebo after concurrent treatment (Phase II) [ Time Frame: Up to 8 years ] [ Designated as safety issue: Yes ]
    Only AEs assessed to be definitely, probably, or possibly related to protocol treatment will be considered. The rates of adverse events, discontinuation of treatment, and response will be estimated using a binomial distribution along with their associated 95% confidence intervals and will be compared using Fisher's exact test.

  • Response of the primary site in patients with measurable disease following chemoradiation as per RECIST version 1.1 (Phase II) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Estimated using a binomial distribution along with their associated 95% confidence intervals and will be compared using Fisher's exact test.


Estimated Enrollment: 121
Study Start Date: October 2010
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (paclitaxel, pazopanib hydrochloride, IMRT)
Patients receive paclitaxel IV over 1 hour once weekly and pazopanib hydrochloride PO QD for 2-3 weeks. Patients then receive concurrent paclitaxel IV over 1 hour once weekly and pazopanib hydrochloride PO QD for 6-7 weeks (or until radiation treatment is completed) and IMRT 5 days per week for 6.5 weeks (total of 66 Gy in 33 fractions). Beginning 25-31 days after the completion of IMRT, patients receive paclitaxel IV over 1 hour once weekly and pazopanib hydrochloride PO QD. Treatment repeats every 3 weeks for 4 courses (for patients with no measurable disease) or continues in the absence of disease progression or unacceptable toxicity (for patients with measurable disease).
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat
Drug: Pazopanib Hydrochloride
Given PO
Other Names:
  • GW786034B
  • Votrient
Active Comparator: Arm II (paclitaxel, placebo, IMRT)
Patients receive paclitaxel IV over 1 hour once weekly and placebo PO QD for 2-3 weeks. Patients then receive concurrent paclitaxel IV over 1 hour once weekly and placebo PO QD for 6-7 weeks (or until radiation treatment is completed) and IMRT 5 days per week for 6.5 weeks (total of 66 Gy in 33 fractions). Beginning 25-31 days after the completion of IMRT, patients receive paclitaxel IV over 1 hour once weekly and placebo PO QD. Treatment repeats every 3 weeks for 4 courses (for patients with no measurable disease) or continues in the absence of disease progression or unacceptable toxicity (for patients with measurable disease).
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat
Other: Placebo
Given PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of anaplastic thyroid cancer (a diagnosis that is noted to be "consistent with anaplastic thyroid cancer" with the presence of a thyroid mass is acceptable)

    • Note: tissue collection for central review is mandatory, but central review is not required for eligibility; treatment will be started prior to central review
  • If there was a total or partial thyroidectomy completed within 3 months of enrollment, the surgical specimen must show the area of anaplastic thyroid cancer to be at least 1 cm in greatest dimension
  • The following minimum diagnostic workup is required:

    • History/physical examination within 2 weeks prior to registration
    • Imaging of neck and brain (computed tomography [CT] scan or magnetic resonance imaging [MRI]) and chest/abdominal imaging (chest x-ray or chest CT scan, or full body positron emission tomography [PET]/CT are acceptable) within 4 weeks prior to registration
    • Note: the CT scan of the neck must be done with contrast or if an MRI is done, with gadolinium; therefore, the CT portion of a full body PET/CT has to be a high resolution CT to be acceptable for eligibility
    • Abdominal imaging must cover the liver and adrenal glands; therefore, separate imaging is not required if these areas are covered by a chest CT scan
    • Electrocardiogram within 10 days prior to registration
  • Zubrod performance status 0-2
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin (Hgb) >= 9.0 g/dL (Note: the use of transfusion or other intervention to achieve Hgb >= 9.0 g/dL is acceptable)
  • Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (except for patients with Gilbert's syndrome and elevations of indirect bilirubin)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x institutional ULN ; note: patients who have both bilirubin > ULN and AST/ALT > ULN are not eligible (unless they have Gilbert's syndrome and elevations of indirect bilirubin)
  • Spot urine protein to creatinine ratio (UPCR) < 1 or a 24-hour urine protein collection < 1 gm within 10 days prior to registration
  • Creatinine < 1.5 mg/dL or within normal institutional limits within 10 days prior to registration; Note: if neither criteria is met, the creatinine clearance must be > 50 mL/min/1.73 m^2 per either the Cockcroft-Gault equation, Jeliffe method, or 12- or 24-hour urine collection
  • Serum electrolytes including sodium, potassium, blood urea nitrogen (BUN), creatinine, glucose, magnesium, phosphate, and calcium within 10 days prior to registration
  • Documentation of the patient's history of corrected QT interval (QTc) prolongation, family history of prolonged QTc, and relevant cardiac disease within 10 days prior to registration
  • Evaluation of the patient's medications within 10 days prior to registration with attempt to change any medication that affects cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
  • Blood pressure =< 140/90 within 10 days of registration (must be taken and recorded by a health care professional); Note: if the systolic blood pressure is > 140 and/or diastolic blood pressure is > 90 at the time of registration, the patient's blood pressure must be controlled; systolic blood pressure must be < 140 and diastolic blood pressure must be < 90 on at least 2 separate measurements prior to the start of treatment, and the treating physician must believe that this is feasible in order to enroll the patient
  • Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 x the upper limit of normal within 10 days prior to registration unless the patient is receiving coumadin and has a stable INR that is in range for the desired level of anticoagulation
  • Negative pregnancy test (serum or urine) within 10 days of registration in women of child-bearing potential
  • Women of childbearing potential and male participants who are sexually active must agree to practice adequate contraception during treatment and for 6 months post-treatment
  • The patient must provide study specific informed consent prior to study entry

Exclusion Criteria:

  • Known active invasive malignancy (except for non-melanomatous skin cancer or anaplastic thyroid cancer; the presence of prostate cancer confined to the prostate with a prostate-specific antigen [PSA] =< 1 ng/mL for more than 6 months also is allowed)
  • Prior systemic chemotherapy for anaplastic thyroid cancer

    • Patients who have had chemotherapy or radiotherapy within 4 weeks of registration (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 > 4 weeks previously
    • Patients receiving other investigational agents
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Patients with any of the following cardiovascular conditions within the past 6 months:

    • Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
    • Admission for unstable angina
    • Myocardial Infarction
    • Cardiac angioplasty or stenting
    • Coronary artery bypass graft surgery
    • Pulmonary embolism, untreated deep venous thrombosis (DVT), or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks
    • Arterial thrombosis
    • Symptomatic peripheral vascular disease
    • Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; Note: a patient who has a history of class III heart failure and is asymptomatic on treatment may be considered eligible for the study
  • Certain medications that are associated with a risk for QTc prolongation and/or torsades de pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible
  • Patients who require heparin (other than low-molecular weight heparin)
  • Patients with any condition that may impair the ability to absorb oral medications/investigational product including:

    • Prior surgical procedures affecting absorption including, but not limited to, major resection of stomach or small bowel
    • Active peptic ulcer disease
    • Malabsorption syndrome
  • Patients with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:

    • Active peptic ulcer disease
    • Known intraluminal metastatic lesions
    • Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation
    • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
  • History of hemoptysis within 30 days of registration; Note: patients who have minimal bleeding from the mouth, which is clearly not related to a source in the lungs, i.e., surgery such as a non-lung biopsy, are eligible only after good hemostasis has been documented
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Prior allergic reaction to the study drug(s) involved in this protocol
  • QTc prolongation defined as a QTc interval >= 480 msecs or other significant electrocardiogram (EKG) abnormalities are ineligible; Note: if unsure about EKG abnormality, the treating physician should discuss this with Drs. Sherman or Bible
  • Known brain metastasis
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy
  • Certain medications that act through the cytochrome P450 (CYP450) system are specifically prohibited in patients receiving pazopanib and others should be avoided or administered with extreme caution

    • Strong inhibitors of CYP3A4 such as ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole may increase pazopanib concentrations and are prohibited; although, in exceptional circumstances, they may be administered in conjunction with lowering the dose of pazopanib by 50% of what would otherwise be administered; grapefruit juice is also an inhibitor of CYP450 and should not be taken with pazopanib
    • Strong inducers of CYP3A4, such as rifampin, may decrease pazopanib concentrations, are strictly prohibited
    • Medications that have narrow therapeutic windows and are substrates of CYP3A4, cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6), or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) should be avoided and, if necessary, administered with caution
  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: NCT01236547

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Cancer Center Recruiting
Birmingham, Alabama, United States, 35233
Contact: Sharon A. Spencer    205-934-0309      
Principal Investigator: Sharon A. Spencer         
The Kirklin Clinic at Acton Road Recruiting
Birmingham, Alabama, United States, 35243
Contact: Sharon A. Spencer    205-934-0309      
Principal Investigator: Sharon A. Spencer         
United States, Arizona
University of Arizona Cancer Center at Saint Joseph's Suspended
Phoenix, Arizona, United States, 85004
Saint Joseph's Hospital and Medical Center Suspended
Phoenix, Arizona, United States, 85013
Arizona Oncology-Deer Valley Center Active, not recruiting
Phoenix, Arizona, United States, 85027
Arizona Oncology Services Foundation Suspended
Scottsdale, Arizona, United States, 85260
United States, California
Sutter Cancer Centers Radiation Oncology Services-Auburn Recruiting
Auburn, California, United States, 95603
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
Alta Bates Summit Medical Center-Herrick Campus Active, not recruiting
Berkeley, California, United States, 94704
Mills - Peninsula Hospitals Active, not recruiting
Burlingame, California, United States, 94010
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Recruiting
Cameron Park, California, United States, 95682
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
Eden Hospital Medical Center Active, not recruiting
Castro Valley, California, United States, 94546
Sutter Cancer Centers Radiation Oncology Services-Roseville Recruiting
Roseville, California, United States, 95661
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
Sutter General Hospital Recruiting
Sacramento, California, United States, 95816
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
California Pacific Medical Center-Pacific Campus Active, not recruiting
San Francisco, California, United States, 94115
UCSF Medical Center-Mount Zion Recruiting
San Francisco, California, United States, 94115
Contact: Adam Garsa    877-827-3222      
Principal Investigator: Adam Garsa         
UCSF Medical Center-Parnassus Active, not recruiting
San Francisco, California, United States, 94143
Sutter Cancer Centers Radiation Oncology Services-Vacaville Recruiting
Vacaville, California, United States, 95687
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
Sutter Solano Medical Center/Cancer Center Active, not recruiting
Vallejo, California, United States, 94589
United States, Delaware
Christiana Gynecologic Oncology LLC Active, not recruiting
Newark, Delaware, United States, 19713
Delaware Clinical and Laboratory Physicians PA Active, not recruiting
Newark, Delaware, United States, 19713
Helen F Graham Cancer Center Active, not recruiting
Newark, Delaware, United States, 19713
Medical Oncology Hematology Consultants PA Active, not recruiting
Newark, Delaware, United States, 19713
Regional Hematology and Oncology PA Active, not recruiting
Newark, Delaware, United States, 19713
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Adam Raben    302-733-6227      
Principal Investigator: Adam Raben         
Beebe Health Campus Active, not recruiting
Rehoboth Beach, Delaware, United States, 19971
Christiana Care Health System-Wilmington Hospital Active, not recruiting
Wilmington, Delaware, United States, 19801
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224-9980
Contact: Robert L. Foote    855-776-0015    foote.robert@mayo.edu   
Principal Investigator: Robert L. Foote         
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Jimmy J. Caudell    800-456-7121    canceranswers@moffitt.org   
Principal Investigator: Jimmy J. Caudell         
United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Contact: Kristin A. Higgins    404-778-1868      
Principal Investigator: Kristin A. Higgins         
Emory University/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kristin A. Higgins    404-778-1868      
Principal Investigator: Kristin A. Higgins         
United States, Indiana
Radiation Oncology Associates PC Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Brian K. Chang    260-373-8888    parkviewresearch@parkview.com   
Principal Investigator: Brian K. Chang         
Parkview Hospital Randallia Recruiting
Fort Wayne, Indiana, United States, 46805
Contact: Brian K. Chang    260-373-8888    parkviewresearch@parkview.com   
Principal Investigator: Brian K. Chang         
United States, Kansas
University of Kansas Cancer Center Active, not recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
The James Graham Brown Cancer Center at University of Louisville Suspended
Louisville, Kentucky, United States, 40202
United States, Louisiana
Mary Bird Perkins Cancer Center Active, not recruiting
Baton Rouge, Louisiana, United States, 70809
Touro Infirmary Active, not recruiting
New Orleans, Louisiana, United States, 70115
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Geoffrey A. Neuner    443-849-3706      
Principal Investigator: Geoffrey A. Neuner         
Sinai Hospital of Baltimore Withdrawn
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Minh T. Truong    617-638-8265    minh-tam.truong@bmc.org   
Principal Investigator: Minh T. Truong         
United States, Michigan
Henry Ford Macomb Hospital Active, not recruiting
Clinton Township, Michigan, United States, 48038
Henry Ford Medical Center-Fairlane Active, not recruiting
Dearborn, Michigan, United States, 48126
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Eleanor M. Walker    313-916-1784      
Principal Investigator: Eleanor M. Walker         
West Michigan Cancer Center Withdrawn
Kalamazoo, Michigan, United States, 49007
Henry Ford Medical Center-Columbus Active, not recruiting
Novi, Michigan, United States, 48377
Downriver Center for Oncology Active, not recruiting
Trenton, Michigan, United States, 48183
Henry Ford Medical Center - West Bloomfield Active, not recruiting
West Bloomfield, Michigan, United States, 48322
United States, Minnesota
Fairview Ridges Hospital Active, not recruiting
Burnsville, Minnesota, United States, 55337
Mercy Hospital Active, not recruiting
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital Active, not recruiting
Edina, Minnesota, United States, 55435
Unity Hospital Active, not recruiting
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology PA-Maplewood Active, not recruiting
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital Active, not recruiting
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center Active, not recruiting
Minneapolis, Minnesota, United States, 55415
North Memorial Medical Health Center Active, not recruiting
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Robert L. Foote    855-776-0015    foote.robert@mayo.edu   
Principal Investigator: Robert L. Foote         
Metro Minnesota Community Oncology Research Consortium Terminated
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park Active, not recruiting
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
United Hospital Active, not recruiting
Saint Paul, Minnesota, United States, 55102
Ridgeview Medical Center Active, not recruiting
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital Active, not recruiting
Willmar, Minnesota, United States, 56201
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Shankar P. Giri    601-815-6700      
Principal Investigator: Shankar P. Giri         
United States, Montana
Billings Clinic Cancer Center Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Eric J. Sherman    212-639-7202      
Principal Investigator: Eric J. Sherman         
United States, New York
The New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Krishnamurthi Sundaram    718-270-8216    sima.terebelo@downstate.edu   
Principal Investigator: Krishnamurthi Sundaram         
Memorial Sloan Kettering Cancer Center Commack Recruiting
Commack, New York, United States, 11725
Contact: Eric J. Sherman    212-639-7202      
Principal Investigator: Eric J. Sherman         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Eric J. Sherman    212-639-7202      
Principal Investigator: Eric J. Sherman         
Memorial Sloan-Kettering Cancer Center Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: Eric J. Sherman    212-639-7202      
Principal Investigator: Eric J. Sherman         
Memorial Sloan-Kettering Cancer Center Sleepy Hollow Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Eric J. Sherman    212-639-7202      
Principal Investigator: Eric J. Sherman         
Memorial Sloan-Kettering Cancer Center West Harrison Recruiting
West Harrison, New York, United States, 10604
Contact: Eric J. Sherman    212-639-7202      
Principal Investigator: Eric J. Sherman         
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Suspended
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center Withdrawn
Akron, Ohio, United States, 44304
Summa Barberton Hospital Withdrawn
Barberton, Ohio, United States, 44203
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Kevin P. Redmond    513-558-4553    uchealthnews@uc.edu   
Principal Investigator: Kevin P. Redmond         
Case Western Reserve University Withdrawn
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: David J. Adelstein    866-223-8100    adelstd@ccf.org   
Principal Investigator: David J. Adelstein         
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Manisha H. Shah    800-293-5066    Jamesline@osumc.edu   
Principal Investigator: Manisha H. Shah         
Mercy Cancer Center-Elyria Withdrawn
Elyria, Ohio, United States, 44035
Summa Health Center at Lake Medina Withdrawn
Medina, Ohio, United States, 44256
Lake University Ireland Cancer Center Withdrawn
Mentor, Ohio, United States, 44060
Southwest General Health Center Ireland Cancer Center Withdrawn
Middleburg Heights, Ohio, United States, 44130
University Hospitals Parma Medical Center Withdrawn
Parma, Ohio, United States, 44129
Ireland Cancer Center at Firelands Regional Medical Center Active, not recruiting
Sandusky, Ohio, United States, 44870
University Pointe Recruiting
West Chester, Ohio, United States, 45069
Contact: Kevin P. Redmond    513-558-4553    uchealthnews@uc.edu   
Principal Investigator: Kevin P. Redmond         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Terence S. Herman    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Terence S. Herman         
United States, Pennsylvania
UPMC-Heritage Valley Health System Beaver Active, not recruiting
Beaver, Pennsylvania, United States, 15009
UPMC Cancer Centers - Arnold Palmer Pavilion Recruiting
Greensburg, Pennsylvania, United States, 15601
Contact: James P. Ohr    412-647-8073      
Principal Investigator: James P. Ohr         
Penn State Milton S Hershey Medical Center Withdrawn
Hershey, Pennsylvania, United States, 17033-0850
UPMC-Johnstown/John P. Murtha Regional Cancer Center Active, not recruiting
Johnstown, Pennsylvania, United States, 15901
UPMC Cancer Center at UPMC McKeesport Active, not recruiting
McKeesport, Pennsylvania, United States, 15132
UPMC-Coraopolis/Heritage Valley Radiation Oncology Recruiting
Moon Township, Pennsylvania, United States, 15108
Contact: James P. Ohr    412-647-8073      
Principal Investigator: James P. Ohr         
UPMC Cancer Center-Natrona Heights Terminated
Natrona Heights, Pennsylvania, United States, 15065
Jameson Health System North Campus Terminated
New Castle, Pennsylvania, United States, 16105
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jennifer M. Johnson    215-955-6084      
Principal Investigator: Jennifer M. Johnson         
UPMC-Presbyterian Hospital Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213
UPMC-Saint Margaret Recruiting
Pittsburgh, Pennsylvania, United States, 15215
Contact: James P. Ohr    412-647-8073      
Principal Investigator: James P. Ohr         
UPMC-Shadyside Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: James P. Ohr    412-647-8073      
Principal Investigator: James P. Ohr         
UPMC Jefferson Regional Radiation Oncology Suspended
Pittsburgh, Pennsylvania, United States, 15236
UPMC-Passavant Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15237
Contact: James P. Ohr    412-647-8073      
Principal Investigator: James P. Ohr         
UPMC-Saint Clair Hospital Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15243
Contact: James P. Ohr    412-647-8073      
Principal Investigator: James P. Ohr         
UPMC Cancer Center at UPMC Northwest Active, not recruiting
Seneca, Pennsylvania, United States, 16346
UPMC Uniontown Hospital Radiation Oncology Active, not recruiting
Uniontown, Pennsylvania, United States, 15401
UPMC Washington Hospital Radiation Oncology Active, not recruiting
Washington, Pennsylvania, United States, 15301
United States, South Carolina
Greenville Health System Cancer Institute-Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: David L. Grisell    864-241-6251      
Principal Investigator: David L. Grisell         
Greenville Health System Cancer Institute-Eastside Recruiting
Greenville, South Carolina, United States, 29615
Contact: David L. Grisell    864-241-6251      
Principal Investigator: David L. Grisell         
Greenville Health System Cancer Institute-Greer Recruiting
Greer, South Carolina, United States, 29650
Contact: David L. Grisell    864-241-6251      
Principal Investigator: David L. Grisell         
Greenville Health System Cancer Institute-Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: David L. Grisell    864-241-6251      
Principal Investigator: David L. Grisell         
Greenville Health System Cancer Institute-Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: David L. Grisell    864-241-6251      
Principal Investigator: David L. Grisell         
United States, Texas
Parkland Memorial Hospital Active, not recruiting
Dallas, Texas, United States, 75235
UT Southwestern/Simmons Cancer Center-Dallas Active, not recruiting
Dallas, Texas, United States, 75390
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Gary B. Gunn    713-792-3245      
Principal Investigator: Gary B. Gunn         
United States, Utah
American Fork Hospital / Huntsman Intermountain Cancer Center Recruiting
American Fork, Utah, United States, 84003
Contact: Vilija N. Avizonis    801-507-3950      
Principal Investigator: Vilija N. Avizonis         
Sandra L Maxwell Cancer Center Active, not recruiting
Cedar City, Utah, United States, 84720
Logan Regional Hospital Recruiting
Logan, Utah, United States, 84321
Contact: Vilija N. Avizonis    801-507-3950      
Principal Investigator: Vilija N. Avizonis         
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Vilija N. Avizonis    801-507-3950      
Principal Investigator: Vilija N. Avizonis         
McKay-Dee Hospital Center Recruiting
Ogden, Utah, United States, 84403
Contact: Vilija N. Avizonis    801-507-3950      
Principal Investigator: Vilija N. Avizonis         
Utah Valley Regional Medical Center Recruiting
Provo, Utah, United States, 84604
Contact: Vilija N. Avizonis    801-507-3950      
Principal Investigator: Vilija N. Avizonis         
Dixie Medical Center Regional Cancer Center Recruiting
Saint George, Utah, United States, 84770
Contact: Vilija N. Avizonis    801-507-3950      
Principal Investigator: Vilija N. Avizonis         
Utah Cancer Specialists-Salt Lake City Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Vilija N. Avizonis    801-507-3950      
Principal Investigator: Vilija N. Avizonis         
LDS Hospital Active, not recruiting
Salt Lake City, Utah, United States, 84143
United States, Virginia
Sentara Cancer Institute at Sentara CarePlex Hospital Recruiting
Hampton, Virginia, United States, 23666
Contact: Scott S. Williams    757-388-2406      
Principal Investigator: Scott S. Williams         
Sentara Hospitals Recruiting
Norfolk, Virginia, United States, 23507
Contact: Scott S. Williams    757-388-2406      
Principal Investigator: Scott S. Williams         
Sentara Virginia Beach General Hospital Recruiting
Virginia Beach, Virginia, United States, 23454
Contact: Scott S. Williams    757-388-2406      
Principal Investigator: Scott S. Williams         
United States, Wisconsin
Green Bay Oncology at Saint Vincent Hospital Active, not recruiting
Green Bay, Wisconsin, United States, 54301-3526
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: James L. Leenstra    507-645-2655      
Principal Investigator: James L. Leenstra         
Green Bay Oncology Limited at Saint Mary's Hospital Active, not recruiting
Green Bay, Wisconsin, United States, 54303
Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: James L. Leenstra    507-645-2655      
Principal Investigator: James L. Leenstra         
University of Wisconsin Hospital and Clinics Suspended
Madison, Wisconsin, United States, 53792
Holy Family Memorial Hospital Active, not recruiting
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center Suspended
Marinette, Wisconsin, United States, 54143
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Christopher J. Schultz    414-805-4380      
Principal Investigator: Christopher J. Schultz         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Eric Sherman NRG Oncology
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01236547     History of Changes
Other Study ID Numbers: NCI-2011-02614  NCI-2011-02614  CDR0000688092  RTOG-0912  RTOG-0912  U10CA180868  U10CA021661 
Study First Received: November 5, 2010
Last Updated: August 15, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Thyroid Carcinoma, Anaplastic
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 23, 2016