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Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia - Article


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Chemotherapy

Cancer Chemotherapy


Clinical Trial: Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia

This study is currently recruiting patients.

Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Southwest Oncology Group
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with combination chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy in treating patients who have newly diagnosed Waldenstrom's macroglobulinemia.

Condition Treatment or Intervention Phase
Waldenstrom's Macroglobulinemia
 Drug: cyclophosphamide
 Drug: doxorubicin
 Drug: prednisone
 Drug: rituximab
 Drug: vincristine
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: chemotherapy
 Procedure: monoclonal antibody therapy
Phase II

MedlinePlus related topics:  Blood and Blood Disorders;   Immune System and Disorders;   Lymphatic Diseases;   Vascular Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Pilot Study of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia

Further Study Details: 

OBJECTIVES:

  • Determine the response rate of patients with newly diagnosed Waldenstrom's macroglobulinemia treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.
  • Determine the associated toxic effects of this regimen, specifically the frequency of febrile neutropenia, in these patients.
  • Determine the progression-free survival of patients treated with this regimen.
  • Correlate baseline cytogenetic features and gene expression profiles with response in patients treated with this regimen.

OUTLINE: This is a pilot, multicenter study.

Patients receive rituximab IV over approximately 4 hours, cyclophosphamide IV over 5-30 minutes, doxorubicin IV over 5-15 minutes, and vincristine IV over 1 minute on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study within approximately 6 months.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of Waldenstrom's macroglobulinemia confirmed by the presence of bone marrow lymphoplasmacytosis with 1 of the following:
  • At least 10% lymphoplasmacytic cells
  • Aggregates or sheets of lymphocytes, plasma cells, or lymphoplasmacytic cells on the bone marrow biopsy
  • Measurable disease, defined as a quantitative IgM monoclonal protein of at least 1,000 mg/dL
  • The following indices are not considered measurable disease:
  • Bone marrow lymphoplasmacytosis
  • Beta-2 microglobulin in the serum
  • Impaired bone marrow function due to infiltration by lymphoplasmacytic lymphoma, defined by 1 of the following:
  • Hemoglobin no greater than 11 g/dL
  • Serum viscosity level relative to water of at least 4.0 centipoise
  • CD-positive bone marrow or lymph node cells obtained within the past 8 weeks
  • Must be symptomatic with 1 of the following:
  • Clinically significant anemia (hemoglobin no greater than 11 g/dL)
  • Bulky lymphadenopathy
  • Symptoms attributable to hyperviscosity (e.g., nose bleeding, gingival bleeding, or retinal hemorrhage)

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3

Hepatic

  • Bilirubin no greater than 3.0 mg/dL
  • AST no greater than 3 times upper limit of normal
  • Must have been tested for hepatitis B surface antigen within the past 2 weeks

Renal

  • Creatinine no greater than 3.0 mg/dL

Cardiovascular

  • History of heart disease allowed only if 1 of the following is demonstrated by echocardiography, MUGA, exercise MUGA, or coronary catheterization:
  • Ejection fraction of at least 45%
  • Normal fractional shortening of the left ventricle
  • No active heart disease
  • No myocardial infarction within the past 3 months
  • No congestive heart failure
  • No symptomatic ventricular arrhythmia

Other

PRIOR CONCURRENT THERAPY: Biologic therapy

  • No prior anti-CD20 therapy

Chemotherapy

  • No prior anthracyclines

Endocrine therapy

  • No concurrent steroids exceeding 10 mg prednisone (or equivalent) per day

Radiotherapy

  • At least 4 weeks since prior radiotherapy

Surgery

  • Not specified

Other

  • No prior treatment for Waldenstrom's macroglobulinemia
  • No concurrent dexrazoxane

Location and Contact Information


Alabama
      MBCCOP - Gulf Coast, Mobile,  Alabama,  36607,  United States; Recruiting
Paul O. Schwarzenberger, MD  251-544-1013 

      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
Carla I. Falkson, MD  205-975-2691    cfalkson@uab.edu 

Arizona
      Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson,  Arizona,  85724,  United States; Recruiting
Thomas P. Miller, MD  520-626-2667 

      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States; Recruiting
Tom Robert Fitch, MD  480-301-9875 

      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
David Kyle King, MD, FACP  602-239-2413    david.king@baannerhealth.com 

      Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix,  Arizona,  85012,  United States; Recruiting
Thomas Dale Kummet, MD  602-277-5551 

      Veterans Affairs Medical Center - Tucson, Tucson,  Arizona,  85723,  United States; Recruiting
Harinder S. Garewal, MD  520-629-4686 

Arkansas
      Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States; Recruiting
Laura Fulper Hutchins, MD  501-686-8511    LFHutchins@uams.edu 

      Veterans Affairs Medical Center - Little Rock, Little Rock,  Arkansas,  72205,  United States; Recruiting
Bart Barlogie, MD  501-526-2873 

California
      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States; Recruiting
Joseph Szumowski, MD  510-465-8570 

      CCOP - Santa Rosa Memorial Hospital, Santa Rosa,  California,  95403,  United States; Recruiting
Ian C. Anderson, MD  707-521-3830 

      Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange,  California,  92868,  United States; Recruiting
Randall F. Holcombe, MD  714-456-5153    rholcomb@uci.edu 

      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States; Recruiting
Clinical Trials Office - New Patient Services  800-826-4673    becomingapatient@coh.org 

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States; Recruiting
John L. Barstis, MD  310-825-5268 

      Stanford Cancer Center at Stanford University Medical Center, Stanford,  California,  94305-5216,  United States; Recruiting
Harlan A. Pinto, MD  650-725-9057 

      University of California Davis Cancer Center, Sacramento,  California,  95817,  United States; Recruiting
David R. Gandara, MD  916-734-3772    dgandara@cc.ucdmc.ucdavis.edu 

      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033,  United States; Recruiting
Heinz-Josef Lenz, MD  323-865-3955    lenz@usc.edu 

      Veterans Affairs Medical Center - Loma Linda (Pettis), Loma Linda,  California,  92357,  United States; Recruiting
Mark E. Reeves, MD, PhD  909-583-6064 

      Veterans Affairs Medical Center - Palo Alto, Palo Alto,  California,  94304-1290,  United States; Recruiting
Harlan A. Pinto, MD  650-493-5000 ext. 4948 

      Veterans Affairs Outpatient Clinic - Martinez, Martinez,  California,  94553,  United States; Recruiting
David R. Gandara, MD  925-372-2064 

Colorado
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora,  Colorado,  80010,  United States; Recruiting
Anthony D. Elias, MD  720-848-1622    Anthony.Elias@uchsc.edu 

      Veterans Affairs Medical Center - Denver, Denver,  Colorado,  80220,  United States; Recruiting
Madeleine A. Kane, MD, PhD  303-399-8020 ext. 3129    madeleine.kane@med.va.gov 

Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
Stephen Scott Grubbs, MD  302-623-4100 

District of Columbia
      MBCCOP - Howard University Cancer Center, Washington,  District of Columbia,  20060,  United States; Recruiting
Lucile L. Adams-Campbell, PhD  202-806-7697 

Florida
      H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa,  Florida,  33612-9497,  United States; Recruiting
Cancer Answers  800-456-7121    canceranswers@moffitt.usf.edu 

      Veterans Affairs Medical Center - Gainesville, Gainesville,  Florida,  32608-1197,  United States; Recruiting
Dean Latain McCarley, MD  352-374-6016 

      Veterans Affairs Medical Center - Miami, Miami,  Florida,  33125,  United States; Recruiting
Niramol Savaraj, MD  305-575-3143    nsavaraj@med.miami.edu 

      Veterans Affairs Medical Center - Tampa (Haley), Tampa,  Florida,  33612,  United States; Recruiting
Julie A. Kish, MD, FACP  813-972-2000 

Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States; Recruiting
Thomas E. Seay, MD, PhD  404-851-2340 

      Veterans Affairs Medical Center - Atlanta (Decatur), Decatur,  Georgia,  30033,  United States; Recruiting
Maria Jose Amarante Ribeiro, MD  404-728-7680    maria.ribeiro@med.va.gov 

      Winship Cancer Institute of Emory University, Atlanta,  Georgia,  30322,  United States; Recruiting
William Costin Wood, MD  404-778-5180 

Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Brian F. Issell, MD  808-586-3015    brian@crch.hawaii.edu 

Illinois
      Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood,  Illinois,  60153-5500,  United States; Recruiting
Patrick J. Stiff, MD  708-327-3148 

      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
Kendrith M. Rowland, MD  217-383-4083    kendrith.rowland@carle.com 

      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States; Recruiting
James L. Wade, MD  217-876-6617    jlwade3@sbcglobal.net 

      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
Gershon Y. Locker, MD, FACP  847-570-2518    glocker@enh.org 

      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61615-7828,  United States; Recruiting
John W. Kugler, MD  309-243-3605 

      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
Lawrence Eric Feldman, MD  312-335-3614 

      Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago,  Illinois,  60611,  United States; Recruiting
Al Bowen Benson, MD, FACP  312-695-1382 

      Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago,  Illinois,  60612,  United States; Recruiting
Lawrence Eric Feldman, MD  312-569-6129 

      Veterans Affairs Medical Center - Hines, Hines,  Illinois,  60141,  United States; Recruiting
Nirmala Bhoopalam, MD  708-202-2782 

      Veterans Affairs Medical Center - Lakeside Chicago, Chicago,  Illinois,  60611-4494,  United States; Recruiting
Timothy M. Kuzel, MD  312-469-3748 

Indiana
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States; Recruiting
Rafat H. Ansari, MD, FACP  574-284-7977 

      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States; Recruiting
Patrick J. Loehrer, MD  317-278-7418 

      Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis,  Indiana,  46202,  United States; Recruiting
Patrick J. Loehrer, MD  317-554-0000 

Iowa
      Burgess Health Center, Onawa,  Iowa,  51040,  United States; Recruiting
James A. Mailliard, MD  712-423-2311 

      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States; Recruiting
Martin Wiesenfeld, MD  319-363-8303 

      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-244-7586 

      John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines,  Iowa,  50316-2301,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-663-5612 

      John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines,  Iowa,  50309,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-241-4245 

      Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines,  Iowa,  50314,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-247-3121 

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
Shaker R. Dakhil, MD, FACP  316-268-5784 

      Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City,  Kansas,  66160-7353,  United States; Recruiting
Sarah A. Taylor, MD  913-588-6029    sataylor@kumc.edu 

      Veterans Affairs Medical Center - Wichita, Wichita,  Kansas,  67218,  United States; Recruiting
Shaker R. Dakhil, MD, FACP  316-685-2221 

Kentucky
      Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536-0084,  United States; Recruiting
Michael A. Doukas, MD  859-257-3379 

      Veterans Affairs Medical Center - Lexington, Lexington,  Kentucky,  40502-2236,  United States; Recruiting
Michael A. Doukas, MD  859-281-4956 

Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States; Recruiting
Carl G. Kardinal, MD  504-842-3910 

      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States; Recruiting
Glenn M. Mills, MD  318-675-5970    gmills@lsuhsc.edu 

      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Jill Gilbert, MD  504-568-5613    jgilbe@lsuhsc.edu 

      Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans,  Louisiana,  70112,  United States; Recruiting
Alan M. Miller, MD, PhD  504-587-7566    amiller@tulane.edu 

      Veterans Affairs Medical Center - New Orleans, New Orleans,  Louisiana,  70112,  United States; Recruiting
German S. Beltran, MD  504-588-5482 

      Veterans Affairs Medical Center - Shreveport, Shreveport,  Louisiana,  71101-4295,  United States; Recruiting
Glenn M. Mills, MD  318-221-8411 

Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231,  United States; Recruiting
Arlene A. Forastiere, MD  410-955-9818    af@jhmi.edu 

Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting
Michael Benjamin Atkins, MD  617-667-1930 

      Cancer Center at Tufts - New England Medical Center, Boston,  Massachusetts,  02111,  United States; Recruiting
John K. Erban, MD  617-636-5147    jerban@tufts-nemc.org 

      Cancer Research Center at Boston Medical Center, Boston,  Massachusetts,  02118,  United States; Recruiting
Douglas V. Faller, MD, PhD  617-638-4173 

Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States; Recruiting
Lawrence E. Flaherty, MD  313-745-9155    flaherty@karmanos.org 

      CCOP - Beaumont, Royal Oak,  Michigan,  48073-6769,  United States; Recruiting
Jeanne Archer, PhD, APN  248-551-8299    carcher@beaumon.edu 

      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
Kathleen Jo Yost, MD  616-391-1230 

      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
Raymond Sterling Lord, MD  269-373-7488    rlord@wmcc.org 

      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Philip J. Stella, MD  734-712-5237 

      Josephine Ford Cancer Center at Henry Ford Health System, Detroit,  Michigan,  48202,  United States; Recruiting
Robert Anthony Chapman, MD  313-916-1332    rchapma1@hfhs.org 

      Providence Cancer Institute at Providence Hospital - Southfield, Southfield,  Michigan,  48075,  United States; Recruiting
Anibal Drelichman, MD, MPH, FACP  313-552-0620    adrelichman@yahoo.com 

      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0948,  United States; Recruiting
Laurence H. Baker, DO, FACOI  734-936-3983    bakerl@umich.edu 

      Veterans Affairs Medical Center - Detroit, Detroit,  Michigan,  48201-1932,  United States; Recruiting
Lawrence E. Flaherty, MD  313-576-1000 

Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States; Recruiting
Robert J. Dalton, MD  218-786-8364    rdalton@smdc.org 

      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Patrick J. Flynn, MD  952-993-1517    patrick.flynn@usoncology.com 

      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Morie Abraham Gertz, MD  507-284-4102 

      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
George L. Adams, MD  612-625-2410    adams002@umn.edu 

      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417-2399,  United States; Recruiting
Markus Gapany, MD, FACS  612-725-2000 ext. 3459    gapan001@maroon.tc.umn.edu 

Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States; Recruiting
James Tate Thigpen, MD  601-984-5590    jthigpen@medicine.umsmed.edu 

      Veterans Affairs Medical Center - Biloxi, Biloxi,  Mississippi,  39531-2410,  United States; Recruiting
Robert Woody Veith, MD  504-568-5151 

      Veterans Affairs Medical Center - Jackson, Jackson,  Mississippi,  39216,  United States; Recruiting
James Tate Thigpen, MD  601-362-4471 

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
John Wendall Goodwin, MD  417-269-4520    jwg684@sprg.mercy.net 

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
William T. Stephenson, MD  816-823-0555 

      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States; Recruiting
Bethany G. Sleckman, MD  314-569-6573 

      Saint Louis University Cancer Center, Saint Louis,  Missouri,  63110,  United States; Recruiting
Paul J. Petruska, MD  314-268-5451    petruspj@slu.edu 

      Veterans Affairs Medical Center - Kansas City, Kansas City,  Missouri,  64128,  United States; Recruiting
Sarah A. Taylor, MD  816-861-4700 ext. 491 

Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States; Recruiting
Patrick W. Cobb, MD  406-259-2245 

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
James A. Mailliard, MD  402-280-4364    jamailliard@mrcc.cc 

      Midlands Cancer Center at Midlands Community Hospital, Papillion,  Nebraska,  68128-4157,  United States; Recruiting
James A. Mailliard, MD  402-593-3000 

      Veterans Affairs Medical Center - Omaha, Omaha,  Nebraska,  68105,  United States; Recruiting
James A. Mailliard, MD  402-280-5274 

Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States; Recruiting
John Allan Ellerton, MD, CM  702-384-0013    k.vanwagenen@sncrf.org 

New Hampshire
      Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon,  New Hampshire,  03756-0002,  United States; Recruiting
Camilo E. Fadul, MD  603-650-6312    Camilo.e.fadul@dartmouth.edu 

New Jersey
      Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick,  New Jersey,  08903,  United States; Recruiting
Joseph Aisner, MD  732-235-7401    aisnerjo@umdnj.edu 

      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States; Recruiting
Richard J. Rosenbluth, MD  201-996-5917 

      Veterans Affairs Medical Center - East Orange, East Orange,  New Jersey,  07018,  United States; Recruiting
Basil S. Kasimis, MD, DSc  973-676-1000 ext. 7095    Basil.Kasimis@med.va.gov 

New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States; Recruiting
Cheryl L. Willman, MD  505-272-5837 

      Veterans Affairs Medical Center - Albuquerque, Albuquerque,  New Mexico,  87108-5138,  United States; Recruiting
Cheryl L. Willman, MD  505-265-1711 

New York
      Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx,  New York,  10461,  United States; Recruiting
Joseph A. Sparano, MD  718-904-2555    jsparano@montefiore.org 

      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting
Daniel P. Petrylak, MD  212-305-1731    dpp5@columbia.edu 

      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
Richard I. Fisher, MD  585-275-0842    richard_fisher@urmc.rochester.edu 

      MBCCOP-Our Lady of Mercy Cancer Center, Bronx,  New York,  10466,  United States; Recruiting
Peter H. Wiernik, MD  718-920-9900    pwiernik@olmhs.org 

      NYU Cancer Institute at New York University Medical Center, New York,  New York,  10016,  United States; Recruiting
Amy D. Tiersten, MD  212-652-1916 

      Veterans Affairs Medical Center - Brooklyn, Brooklyn,  New York,  11209,  United States; Recruiting
Andrea Nadine Wiesel Leaf, MD  718-630-3691 

      Veterans Affairs Medical Center - New York, New York,  New York,  10010,  United States; Recruiting
Howard S. Hochster, MD  212-652-1912    howard.hochster@med.nyu.edu 

North Carolina
      CCOP - Southeast Cancer Control Consortium, Goldsboro,  North Carolina,  27534-9479,  United States; Recruiting
James N. Atkins, MD  336-777-3088 

North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States; Recruiting
Preston D. Steen, MD  701-234-6298    prestonsteen@meritcare.com 

Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States; Recruiting
J. Philip Kuebler, MD, PhD  614-488-2118 

      CCOP - Dayton, Dayton,  Ohio,  45429,  United States; Recruiting
Howard M. Gross, MD  937-832-1093 

      CCOP - Toledo Community Hospital, Toledo,  Ohio,  43623-3456,  United States; Recruiting
Paul L. Schaefer, MD  419-843-6147 

      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0501,  United States; Recruiting
Abdul-Rahman Jazieh, MD, MPH  513-584-3830 

      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195-9001,  United States; Recruiting
George Thomas Budd, MD  216-444-6480 

      MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland,  Ohio,  44109,  United States; Recruiting
Edward G. Mansour, MD  216-778-4394    emansour@metrohealth.org 

      Veterans Affairs Medical Center - Cincinnati, Cincinnati,  Ohio,  45220-2288,  United States; Recruiting
Albert F. Muhleman, MD  513-475-6537    albert.muhleman@med.va.gov 

      Veterans Affairs Medical Center - Dayton, Dayton,  Ohio,  45428-1002,  United States; Recruiting
Howard M. Gross, MD  937-268-6511 

Oklahoma
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States; Recruiting
James B. Lockhart, MD  918-491-5878 

      Oklahoma University Medical Center, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Daniel J. Culkin, MD, FACS  405-271-6900    daniel-culkin@ouhsc.edu 

Oregon
      Cancer Institute at Oregon Health and Science University, Portland,  Oregon,  97201-3098,  United States; Recruiting
Craig R. Nichols, MD  503-494-6346 

      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Keith S. Lanier, MD  503-216-6260 

      Veterans Affairs Medical Center - Portland, Portland,  Oregon,  97207,  United States; Recruiting
Christopher W. Ryan, MD  503-220-8262 

Pennsylvania
      Abramson Cancer Center at the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Daniel G. Haller, MD  215-662-6318 

      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
Albert M. Bernath, MD  570-271-6466 

      CCOP - MainLine Health, Wynnewood,  Pennsylvania,  19096,  United States; Recruiting
Paul B. Gilman, MD  610-645-2494 

      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111-2497,  United States; Recruiting
Lori J. Goldstein, MD  215-728-2689    lj_goldstein@fccc.edu 

      Hahnemann University Hospital, Philadelphia,  Pennsylvania,  19102-1192,  United States; Recruiting
Pamela Ann Crilley, DO  215-762-8547 

      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15236,  United States; Recruiting
John Munn Kirkwood, MD  412-692-4724 

      Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States; Recruiting
Witold Boleslaw Rybka, MD, FRCPC  717-531-1050    wrybka@med.hmc.psu.edu 

      Veterans Affairs Medical Center - Pittsburgh, Pittsburgh,  Pennsylvania,  15240,  United States; Recruiting
Timothy Carlos, MD  412-688-6248    timothy.carlos@med.va.gov 

South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States; Recruiting
Jeffrey Kent Giguere, MD  864-241-6251 

      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States; Recruiting
James Dewitt Bearden, MD  864-560-7050 

      Hollings Cancer Center at Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting
Carolyn E. Reed, MD  843-792-9321    reedce@musc.edu 

      Veterans Affairs Medical Center - Charleston, Charleston,  South Carolina,  29401-5799,  United States; Recruiting
Carolyn E. Reed, MD  843-789-7804 

South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States; Recruiting
Loren K. Tschetter, MD  605-328-8044    tidemanb@siouxvalley.org 

Tennessee
      University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis,  Tennessee,  38104,  United States; Recruiting
Mohammad Jahanzeb, MD  901-722-0532 

      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-6307,  United States; Recruiting
David Horton Johnson, MD  615-343-9454    david.h.johnson@vanderbilt.edu 

      Veterans Affairs Medical Center - Memphis, Memphis,  Tennessee,  38104,  United States; Recruiting
Harvey B. Niell, MD  901-523-8990 ext. 5533 

      Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville,  Tennessee,  37212-2637,  United States; Recruiting
Kenneth R. Hande, MD  615-327-4751 

Texas
      Brooke Army Medical Center, Fort Sam Houston,  Texas,  78234-6200,  United States; Recruiting
Mitchell A. Garrison, MD  210-916-3281    mitchell.garrison@cen.amedd.army.mil 

      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
Lucas Wong, MD  254-724-1053    lwong@swmail.sw.org 

      Harrington Cancer Center, Amarillo,  Texas,  79106,  United States; Recruiting
James E. Clarkson, MD  806-359-4673 ext. 228    jclarkson@harringtoncc.org 

      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4095,  United States; Recruiting
Scott Michael Lippman, MD, FACP  713-745-3672 

      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78229-3900,  United States; Recruiting
Geoffrey R. Weiss, MD  210-567-4777    weiss@uthscsa.edu 

      University of Texas Medical Branch, Galveston,  Texas,  77555-0565,  United States; Recruiting
Robert P. Whitehead, MD  409-772-1164    rpwhiteh@utmb.edu 

      Veterans Affairs Medical Center - Amarillo, Amarillo,  Texas,  79106,  United States; Recruiting
Stephen E. Wright, MD  806-359-4673 ext. 230 

      Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio,  Texas,  78229,  United States; Recruiting
Geoffrey R. Weiss, MD  210-617-5186 

      Veterans Affairs Medical Center - Temple, Temple,  Texas,  76504,  United States; Recruiting
Phalguni Mukhopadhyay, MD  254-778-4811 ext. 4809 

Utah
      Huntsman Cancer Institute at University of Utah, Salt Lake City,  Utah,  84112-5550,  United States; Recruiting
Wolfram Samlowski, MD  801-585-0255    wolfram.samlowski@hci.utah.edu 

      Veterans Affairs Medical Center - Salt Lake City, Salt Lake City,  Utah,  84148,  United States; Recruiting
Wolfram Samlowski, MD  801-582-1565 ext. 1272 

Virginia
      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States; Recruiting
John D. Roberts, MD  804-828-0450 

Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States; Recruiting
Lauren Kenneth Colman, MD  253-403-5259    lauren.colman@multicare.org 

      CCOP - Virginia Mason Research Center, Seattle,  Washington,  98101,  United States; Recruiting
Andrew David Jacobs, MD  206-341-0446 

      Puget Sound Oncology Consortium, Seattle,  Washington,  98109,  United States; Recruiting
Saul E. Rivkin, MD  206-386-2441 

      Veterans Affairs Medical Center - Seattle, Seattle,  Washington,  98108,  United States; Recruiting
William H. Schubach, MD  206-764-2265 

Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting
Tarit Kumar Banerjee, MD, FACP  715-387-5511 

      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States; Recruiting
Gerald K. Bayer, MD  920-433-8889 

      Medical College of Wisconsin Cancer Center, Milwaukee,  Wisconsin,  53226-3596,  United States; Recruiting
David H. Vesole, MD, PhD  414-805-4626    dvesole@bmt.mcw.edu 

      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-0001,  United States; Recruiting
James A. Stewart, MD  608-265-8131    stewart@biostat.wisc.edu 

      Veterans Affairs Medical Center - Madison, Madison,  Wisconsin,  53705,  United States; Recruiting
Mark R. Albertini, MD  608-262-7017 

      Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee,  Wisconsin,  53295,  United States; Recruiting
Mohammed A. Raheem, MD  414-384-2000 

Australia, New South Wales
      Westmead Breast Centre at NSW Breast Cancer Institute, Westmead,  New South Wales,  2145,  Australia; Recruiting
Michael B. Barton, MD  61-2-9845-5555    barton@radonc.ish.su.edu 

      Westmead Hospital, Westmead,  New South Wales,  2145,  Australia; Recruiting
Richard Kefford, MD, PhD  61-2-9845-6033 

Peru
      Instituto de Enfermedades Neoplasicas, Lima,  34,  Peru; Recruiting
Carlos Santiago Vallejos-Sologuren, MD  51-14-499-137    postmaster@inen.sld.pe 

Puerto Rico
      MBCCOP - San Juan, San Juan,  00921-3201,  Puerto Rico; Recruiting
Luis Baez-Diaz, MD  787-641-3693    sjccop@prtc.net 

      San Juan City Hospital, San Juan,  00936-7344,  Puerto Rico; Recruiting
Luis Baez-Diaz, MD  787-641-3693    sjccop@prtc.net 

      Veterans Affairs Medical Center - San Juan, San Juan,  00927-5800,  Puerto Rico; Recruiting
Luis Baez-Diaz, MD  787-641-7582    sjccop@prtc.net 

South Africa
      Pretoria Academic Hospital, Pretoria,  0001,  South Africa; Recruiting
Coenraad Frederick Slabber, MD  27-12-354-1054 

Study chairs or principal investigators

Rafat Abonour, MD,  Study Chair,  Indiana University Cancer Center   
Gordon Srkalovic, MD, PhD,  Study Chair,  Sparrow Regional Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000301634; ECOG-E1A02; SWOG-E1A02
Record last reviewed:  December 2004
Last Updated:  April 4, 2005
Record first received:  May 6, 2003
ClinicalTrials.gov Identifier:  NCT00060346
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


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


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