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Non-small Cell Lung Cancer Study US75 (Z-PACT) - Article


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Clinical Trial: Non-small Cell Lung Cancer Study US75 (Z-PACT)

This study is currently recruiting patients.

Sponsored by: Novartis Pharmaceuticals
Information provided by: Novartis Pharmaceuticals

Purpose

This study will evaluate the effects of an investigational drug in combination with chemotherapy in patients with stage IIIB/IV non-small cell lung cancer. This study will measure the effects of this combination on progression of lung cancer, cancer response to treatments, and development of cancer-related bone lesions.

Condition Treatment or Intervention Phase
Non Small Cell Lung Carcinoma
  Drug: zoledronic acid
 Drug: Taxotere
 Drug: Carboplatin
 Phase III

MedlinePlus related topics:  Cancer;   Lung Cancer

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 
Primary Outcomes: Proportion of patients without disease progression
Secondary Outcomes: Time to disease progression; Response rate; Time to progression in bone; Overall survival; Safety
Expected Total Enrollment:  250

Study start: April 2004;  Expected completion: June 2007
Data entry closure: July 2007

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Male or Female patients at least of 18 years old
  • Patients with diagnosed non-small cell lung cancer that cannot be treated by surgery
  • Women must not be pregnant or attempting to become pregnant
  • Able and willing to sign informed consent

Exclusion Criteria:

  • Patients with cancer that has spread to the bone
  • Patients with cancer that has spread to the brain who are receiving treatment
  • Patients with kidney disease
  • Patients treated with other investigational drugs

Location and Contact Information


Alabama
      Clinical Research Consultants, Hoover,  Alabama,  35216,  United States; Recruiting
Linda Hammitt  205-824-3635 
Luigi Bertoli, MD,  Principal Investigator

      Clinical Research Consultants, Hoover,  Alabama,  35216,  United States; Recruiting
Linda Hammitt  205-824-3635    lhammitt@bellsouth.net 
James Carinder, MD,  Principal Investigator

Arizona
      Arizona Oncology Assoc., Tucson,  Arizona,  85715,  United States; Recruiting
Sue Logsdon  520-290-2510 
Manual Modiano, MD,  Principal Investigator

Arkansas
      Highlands Oncology Group, Springdale,  Arkansas,  72764,  United States; Recruiting
Cynthia Merrill-Taylor, RN  479-936-9900  Ext. 25    onc23@hogonc.com 
Thaddeus Beck, MD,  Principal Investigator

      NEA Clinic, Jonesboro,  Arkansas,  72401,  United States; Recruiting
Dawn Smith, RN  870-934-5343 
Allen Nixon, MD,  Principal Investigator

California
      NorthBay Cancer Center, Fairfield,  California,  94533,  United States; Recruiting
Keni Horiuchi, RN, MSN  707-429-6976    khoriuchi@northbay.org 
James M. Long, MD,  Principal Investigator

      UCLA, Los Angeles,  California,  91401,  United States; Recruiting
Cheryl Elzinga  310-206-8106 
Robert Figlin, MD,  Principal Investigator

Colorado
      Northern Hematology-Oncology, Thornton,  Colorado,  80260,  United States; Recruiting
Jackie Torrey  303-650-4042    hematology-oncology@msn.com 
William Eng. Lee, MD,  Principal Investigator

      Cancer Center of Colorado Springs, Colorado Springs,  Colorado,  80907,  United States; Recruiting
Kaye Whitt  719-444-4807 
David Brantley, MD,  Principal Investigator

Florida
      Oceola Cancer Center, Kissimmee,  Florida,  34741,  United States; Recruiting
Donna Bradley  407-933-2775    research@osceolacancercenter.com. 
Arnold I. Miller, MD,  Principal Investigator

      Innovative Medical Research of South Florida, Inc., Miami Shores,  Florida,  33138,  United States; Recruiting
Nazle B Kuylen  305-759-1881    innmednazk@aol.com 
Marc A. Saltzman, MD,  Principal Investigator

      New Hope Cancer Centers, Hudson,  Florida,  34667,  United States; Recruiting
Roni Rich, RN  727-868-9208 
Jorge Ayub, MD,  Principal Investigator

      VA Medical Center, Miami,  Florida,  33125,  United States; Recruiting
Lucy Chua, MD  305-575-3143 
Lucy Chua, MD,  Principal Investigator

      Lynn Regional Cancer Center, Boca Raton,  Florida,  33428,  United States; Recruiting
Lori Kronish, RN  561-883-7503 
Elena Kruglyak, MD,  Principal Investigator

      Hematology-Oncology Associates, Pensacola,  Florida,  32501,  United States; Recruiting
Sharon Barrett, RN  850-444-4785    lrobinson@bhcpns.org 
Allen Patton, MD,  Principal Investigator

      Metcare Oncology, Ormond Beach,  Florida,  32174,  United States; Recruiting
Carol Coyne  386-615-1056    research@metcare.com 
Mitchell Weisberg, MD,  Principal Investigator

Georgia
      Peachtree Hematology & Oncology, Atlanta,  Georgia,  30309,  United States; Recruiting
Polly Searcy  404-350-9853    research@phoc.com 
Charles Henderson, MD,  Principal Investigator

      Emory University, Atlanta,  Georgia,  30322,  United States; Recruiting
Janelle Bowersox  404-778-5959 
Michael Fannuchi, MD,  Principal Investigator

Hawaii
      Straub Clinic & Hospital, Honolulu,  Hawaii,  96813,  United States; Recruiting
Mary Kessel  808-547-5921 
Galen Choy, MD,  Principal Investigator

      Kaiser Foundation Hospital, Honolulu,  Hawaii,  96819,  United States; Recruiting
Marc Takemoto, PharmD, BCOP  808-432-8589    Marc.H.Takemoto@kp.org 
Charles Miller, MD,  Principal Investigator

Illinois
      OSF Center for Cancer Care, Rockford,  Illinois,  61108,  United States; Recruiting
Karen Burton  815-227-2622 
Richard Nora, MD,  Principal Investigator

Indiana
      Northern Indiana Oncology Associates, South Bend,  Indiana,  46617,  United States; Recruiting
Cindy Kay Nagy, RN,OCN  574-472-6400    cnagy@nioallc.com 
Rudolph Modesto Navari, MD,  Principal Investigator

      Oncology Institute of Greater Lafayette, Lafayette,  Indiana,  47904,  United States; Recruiting
Linda Vaders  765-448-7536    vadersl@arnett.com 
Thomas Jones, MD,  Principal Investigator

      Community Hospital, Cancer Research Dept., Munster,  Indiana,  46321,  United States; Recruiting
Mary C. Shields  219-852-6454 
Erwin Robin, MD,  Principal Investigator

Iowa
      Cedar Valley Medical Specialists, Waterloo,  Iowa,  50702,  United States; Recruiting
Kimberly Maxfield  319-272-2700    kmaxfield@cvmspc.com 
Joginder Singh, MD,  Principal Investigator

Kansas
      Kansas City Cancer Ctr. South, Lenexa,  Kansas,  66214,  United States; Recruiting
Sherri Smith  913-541-4637    sherri.smith@usoncology.com 
Kelly Pendergrass, MD,  Principal Investigator

Louisiana
      Mary Bird Perkins Cancer Center, Baton Rouge,  Louisiana,  70809,  United States; Recruiting
Jackie Zito  225-215-1185 
David S Hanson, MD,  Principal Investigator

      Hematology/Oncology Clinic, Baton Rouge,  Louisiana,  70808,  United States; Recruiting
Missy Brown, RN  225-381-6451    melissa.brown@brgeneral.org 
Gerald P. Miletello, MD,  Principal Investigator

      LSU Health Sciences Center, Shreveport,  Louisiana,  71103,  United States; Recruiting
Alisha Weatherford  318-813-1406    aweath@lsuhsc.edu 
Glenn M Mills, MD,  Principal Investigator

Maine
      Maine Center for Cancer Medicine, Scarborough,  Maine,  04074,  United States; Recruiting
Barbara Wood, RN,OCN,CCRC  207-885-7634 
Tracey F. Weisberg, MD,  Principal Investigator

Maryland
      Oncology Care Associates, Bethesda,  Maryland,  20817,  United States; Recruiting
Melissa Hyman  301-896-3221 
Cheryl A. Aylesworth, MD,  Principal Investigator

Massachusetts
      Berkshire Hematology Oncology PC, Pittsfield,  Massachusetts,  01201,  United States; Recruiting
Gloria Gero, CCRA  413-496-8205 
Harvey Zimbler, MD,  Principal Investigator

Michigan
      Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States; Recruiting
Mary Ellen Hylton  313-993-2514 
Antoinette Wozniak, MD,  Principal Investigator

Missouri
      St. Louis Cancer Care, Chesterfield,  Missouri,  63017,  United States; Recruiting
Sally Grun, RN, OCN  314-579-0051 
Daniel Cuevas, MD,  Principal Investigator

Nebraska
      Odyssey Research, Scottsbluff,  Nebraska,  69361,  United States; Recruiting
Kim Magana  308-632-2899    kmagana@odysseyresearch.org 
Vince Bjorling, MD,  Principal Investigator

Nevada
      Nevada Cancer Center, Las Vegas,  Nevada,  89109,  United States; Recruiting
Sandy Lahr, RN, MSN  702-735-7154  Ext. 145 
Carlos William Araujo, MD,  Principal Investigator

      Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States; Recruiting
Jaya Kamath, MS,MT  702-384-0013    j.kamath@sncrf.com 
John A. Ellerton, MD,  Principal Investigator

New Jersey
      Hematology/Oncology Assoc. of South Jersey, Mt. Holly,  New Jersey,  08060,  United States; Recruiting
Teri Grand, CCRA  609-267-0700  Ext. 43188    tgrand@virtua.org 
Michael Entmacher, MD,  Principal Investigator

      Cancer Institute of New Jersey at Cooper University Hospital, Voorhees,  New Jersey,  08043,  United States; Recruiting
Pat McLaughlin, RN, MSN,AOCN  856-325-6750    mclaughlin-pat@cooperhealth.edu 
Alexandre Hageboutros, MD,  Principal Investigator

      East Orange VA Medical System, East Orange,  New Jersey,  07018,  United States; Recruiting
Ilda Boholi  973-395-7087 
Basil Kasimis, MD,  Principal Investigator

      Howell Office Plaza, Howell,  New Jersey,  07731,  United States; Recruiting
Ann Walsh, MD  732-367-1535    awalsh1218@aol.com 
Kenneth Nahum, MD,  Principal Investigator

New Mexico
      New Mexico Cancer Care Associates, Santa Fe,  New Mexico,  87505,  United States; Recruiting
Carmen Angel, RN, CCRC  505-955-7910    carmen.angel@nmcancercare.com 
Timothy M. Lopez, MD,  Principal Investigator

      New Mexico Oncology Hematology Consultants, Ltd., Albuquerque,  New Mexico,  87109,  United States; Recruiting
Wanda Laughry  505-243-4039 
Richard Guidice, MD,  Principal Investigator

New York
      Syracuse VA Medical Center, Syracuse,  New York,  13210,  United States; Recruiting
Kristine White  315-425-3459    kristine.white3@med.va.gov 
Ajeet Gajra, MD,  Principal Investigator

      James P. Wilmot Cancer Center, Rochester,  New York,  16642,  United States; Recruiting
Mary Lou Salemi  585-275-8213 
Kishan Pandya, MD,  Principal Investigator

North Carolina
      Southern Oncology Research, Grifton,  North Carolina,  28530,  United States; Recruiting
Rosemary Wallace, RN,CRC  252-413-6628 
J. Thomas Lee, MD,  Principal Investigator

      Presbyterian Hospital, Charlotte,  North Carolina,  28204,  United States; Recruiting
Phyllis Cooper  704-384-5925    prcooper@novanthealth.org 
Richard B. Reiling, MD,  Principal Investigator

Ohio
      Barberton Citizens Hospital-Cancer Center, Barberton,  Ohio,  44203,  United States; Recruiting
Ron Smetana  330-861-2046    rsmetana@barbhosp.com 
Sandra Hazra, MD,  Principal Investigator

      Dayton Clinical Oncology Program, Dayton,  Ohio,  45429,  United States; Not yet recruiting
Carrie Andrews  937-395-8678 
Nandagopal Vrindavanam, MD,  Principal Investigator

Oklahoma
      Cancer Specialists of Oklahoma, Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
Becky Lowrey, MD  405-942-9200 
Charles Hollen, MD,  Principal Investigator

Oregon
      Hematology Oncology Associates, Medford,  Oregon,  97504,  United States; Recruiting
Maya Hawkins-Carter  541-608-5003 
Gerald Ahmann, MD,  Principal Investigator

South Carolina
      Charleston Hematology Oncology, Charleston,  South Carolina,  29403,  United States; Recruiting
Deborah McNeal, RN, OCN  843-577-6957    deborah.mcneal@chashematology.com 
George F. Geils, Sr., MD,  Principal Investigator

      Santee Hematology/Oncology, Sumter,  South Carolina,  29150,  United States; Recruiting
Wei Chang  803-934-8833 
Bill Clowney, MD,  Principal Investigator

      Charleston Cancer Center, Charleston,  South Carolina,  29406,  United States; Recruiting
L. Michele DeCandio, RN,OCN,CCRP  843-576-1006    michele@charlestoncancer.com 
Charles S. Holladay, MD,  Principal Investigator

Tennessee
      The Jones Clinic, Germantown,  Tennessee,  38138,  United States; Recruiting
Raven Jewitt  901-685-5969    rjewitt@cancercareofmemphis.com 
C. Michael Jones, MD,  Principal Investigator

Texas
      Blood and Cancer Center of East Texas, Tyler,  Texas,  75701,  United States; Recruiting
Jeanetta Patterson, RN  903-531-8850    jpatterson@etmc.org 
Gary E. Gross, MD,  Principal Investigator

      Cancer Specialists of South Texas, Corpus Christi,  Texas,  78412,  United States; Recruiting
Katrina Powell, CCRC  361-993-3456 
Albert J. Wood, MD,  Principal Investigator

West Virginia
      West Virginia University, Morgantown,  West Virginia,  26506,  United States; Recruiting
Ryan Adamec, RN,BSN  304-293-7375 
John Rogers, MD,  Principal Investigator

More Information

Study ID Numbers:  CZOL446EUS75; US 75; ZPACT
Record last reviewed:  March 2005
Last Updated:  March 21, 2005
Record first received:  June 29, 2004
ClinicalTrials.gov Identifier:  NCT00086268
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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