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3-AP and Gemcitabine as Second-Line Therapy in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer

This study is currently recruiting patients.

Sponsored by: Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining 3-AP with gemcitabine may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining 3-AP with gemcitabine as second-line therapy in treating patients who have progressive or recurrent non-small cell lung cancer.

Condition Treatment or Intervention Phase
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer
 Drug: 3-AP
 Drug: gemcitabine
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lung Cancer;   Respiratory Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of 3-AP (Triapine®) and Gemcitabine as Second-Line Treatment in Patients With Progressive or Recurrent Non-Small Cell Lung Cancer

Further Study Details: 

OBJECTIVES: Primary

Secondary

OUTLINE: This is a multicenter study.

Patients receive 3-AP (Triapine^®) IV over 2 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for up to 1.5 years.

PROJECTED ACCRUAL: A total of 20-48 patients will be accrued for this study within 5 months.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

Performance status

Life expectancy

Hematopoietic

Hepatic

Renal

Cardiovascular

Pulmonary

Other

PRIOR CONCURRENT THERAPY: Biologic therapy

Chemotherapy

Endocrine therapy

Radiotherapy

Surgery

Other


Location and Contact Information


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

California
      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 

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

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

Colorado
      CCOP - Colorado Cancer Research Program, Incorporated, Denver,  Colorado,  80224,  United States; Recruiting
Eduardo R. Pajon, MD  303-777-2663 

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, 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  305-324-3143    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
      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 

Illinois
      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@aol.com 

      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,  61602,  United States; Recruiting
John W. Kugler, MD  309-636-3605 

      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 - 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 

      Des Moines General Hospital, Des Moines,  Iowa,  50309,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-247-3121 

      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  316-268-5784 

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

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

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

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 

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

Michigan
      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  877-590-5995 

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
Thomas M. Habermann, MD  507-284-2511 

      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  612-725-2000 ext. 3459    gapan001@maroon.tc.umn.edu 

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.vavwagenen@sncrf.com 

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 Robert Wood Johnson University Hospital, 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,  07019,  United States; Recruiting
Basil S. Kasimis, MD, DSc  973-676-1000 ext. 1544    Basil.Kasimis@med.va.gov 

New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States; Recruiting
Cynthia K. Cathcart, MD  505-272-5688 

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

      MBCCOP-Our Lady of Mercy Cancer Center, Bronx,  New York,  10466,  United States; Recruiting
Peter H. Wiernik, MD  718-920-1100    pwiernik@aol.com 

      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States; Recruiting
Howard S. Hochster, MD  212-731-5100    howard.hochster@med.nyu.edu 

      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 Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States; Recruiting
Preston D. Steen, MD  701-234-6161 

Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States; Recruiting
J. Philip Kuebler, MD, PhD  614-443-2267 

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

      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States; Recruiting
Robert Dreicer, MD, FACP  216-445-4623 

      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 

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

Pennsylvania
      Abramson Cancer Center of the University of Pennsylvania Medical Center, 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 Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States; Recruiting
Loren K. Tschetter, MD  605-328-8044    cincod@siouxvalley.org 

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

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

Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting
Tarit Kumar Banerjee, MD, FACP  715-387-5134 

      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54307-3453,  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 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

Anne Traynor, MD,  Study Chair,  University of Wisconsin Comprehensive Cancer Center   
Julie Brahmer, MD,  Sidney Kimmel Cancer Center   

More Information

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

Study ID Numbers:  CDR0000350200; ECOG-E1503
Record last reviewed:  August 2004
Record first received:  February 10, 2004
ClinicalTrials.gov Identifier:  NCT00077350
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-29
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