Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over NCI ECOG-E1503

Objectives

Primary

1. Determine the antitumor response rate in patients with progressive or recurrent non-small cell lung cancer receiving 3-AP (Triapine^®) and gemcitabine as second-line treatment.

Secondary

1. Determine the rate of stable disease in patients treated with this regimen.
2. Determine the time to treatment progression in patients treated with this regimen.
3. Determine the duration of response in patients treated with this regimen.
4. Determine the survival of patients treated with this regimen.
5. Assess the safety and tolerability of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed non-small cell lung cancer
  • Progressive or recurrent disease



• Failed 1, and only 1, prior cytotoxic chemotherapy regimen for advanced disease



• Measurable disease



• Prior brain metastases allowed provided the following are true:
  • More than 3 weeks since prior therapy for brain metastases
  • Neurologically stable

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• No prior gemcitabine
• At least 3 weeks since prior cytotoxic chemotherapy and recovered

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy

Surgery

• See Disease Characteristics

Other

• More than 1 month since prior investigational agents
• No concurrent combination antiretroviral therapy for HIV-positive patients

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• More than 3 months

Hematopoietic

• Absolute granulocyte count at least 1,500/mm³
• Hemoglobin at least 9 g/dL
• Platelet count at least 100,000/mm³
• WBC at least 3,000/mm³
• No G6PD deficiency (for patients of African, Asian, or Mediterranean origin or ancestry)

Hepatic

• AST less than 3 times upper limit of normal (ULN)
• Bilirubin less than 1.5 times ULN

Renal

• Creatinine no greater than 1.5 mg/dL

  OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No myocardial infarction within the past 6 months
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia requiring medical intervention
  • Patients with chronic, stable, asymptomatic atrial fibrillation allowed

Pulmonary

• No pulmonary disease requiring oxygen

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other concurrent uncontrolled illness
• No ongoing or active infection
• No prior allergic reactions to compounds of similar chemical or biological composition to 3-AP (Triapine^®) or other study agents
• No psychiatric illness or social situation that would preclude study compliance
• No dementia or active psychosis
• No active second malignancy

Projected Accrual

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

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.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

The study sites listed for this clinical trial are potential study sites; however, not all sites may be participating.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Anne Traynor, MD, Protocol chair		Ph: 608-263-5389; 800-622-8922
Julie Brahmer, MD, Protocol co-chair		Ph: 410-502-7159

U.S.A.
Alabama
	Birmingham
	University of Alabama at Birmingham Comprehensive Cancer Center
		Carla Falkson, MD	Ph:  205-975-2691
			Email: cfalkson@uab.edu
Arizona
	Scottsdale
	CCOP - Mayo Clinic Scottsdale Oncology Program
		Tom Fitch, MD	Ph:  480-301-9875
California
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - New Patient Services	Ph:  800-826-4673
			Email: becomingapatient@coh.org
	Palo Alto
	Veterans Affairs Medical Center - Palo Alto
		Harlan Pinto, MD	Ph:  650-493-5000 ext. 4948
	Stanford
	Stanford Cancer Center at Stanford University Medical Center
		Harlan Pinto, MD	Ph:  650-725-9057
Delaware
	Newark
	CCOP - Christiana Care Health Services
		Stephen Grubbs, MD	Ph:  302-623-4100
District of Columbia
	Washington
	MBCCOP - Howard University Cancer Center
		Lucile Adams-Campbell, PhD	Ph:  202-806-7697
Florida
	Gainesville
	Veterans Affairs Medical Center - Gainesville
		Dean McCarley, MD	Ph:  352-374-6016
	Miami
	Veterans Affairs Medical Center - Miami
		Niramol Savaraj, MD	Ph:  305-324-3143
			Email: nsavaraj@med.miami.edu
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute
		Cancer Answers	Ph:  800-456-7121
			Email: canceranswers@moffitt.usf.edu
	Veterans Affairs Medical Center - Tampa (Haley)
		Julie Kish, MD, FACP	Ph:  813-972-2000
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		William Wood, MD	Ph:  404-778-5180 888-946-7447
	Decatur
	Veterans Affairs Medical Center - Atlanta (Decatur)
		Maria Jose Amarante Ribeiro, MD	Ph:  404-728-7680
			Email: maria.ribeiro@med.va.gov
Illinois
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Al Benson, MD, FACP	Ph:  312-695-1382
	Veterans Affairs Medical Center - Lakeside Chicago
		Timothy Kuzel, MD	Ph:  312-469-3748
	Decatur
	CCOP - Central Illinois
		James Wade, MD	Ph:  217-876-6617
			Email: jlwade3@aol.com
	Evanston
	CCOP - Evanston
		Gershon Locker, MD, FACP	Ph:  847-570-2518
			Email: glocker@enh.org
	Peoria
	CCOP - Illinois Oncology Research Association
		John Kugler, MD	Ph:  309-243-3605 800-793-2262
	Urbana
	CCOP - Carle Cancer Center
		Kendrith Rowland, MD	Ph:  217-383-4083
			Email: kendrith.rowland@carle.com
Indiana
	Indianapolis
	Indiana University Cancer Center
		Patrick Loehrer, MD	Ph:  317-278-7418 888-600-4822
	Veterans Affairs Medical Center - Indianapolis (Roudebush)
		Patrick Loehrer, MD	Ph:  317-554-0000
	South Bend
	CCOP - Northern Indiana CR Consortium
		Rafat Ansari, MD, FACP	Ph:  574-284-7977 800-284-7370
Iowa
	Cedar Rapids
	CCOP - Cedar Rapids Oncology Project
		Martin Wiesenfeld, MD	Ph:  319-363-8303
	Des Moines
	CCOP - Iowa Oncology Research Association
		Roscoe Morton, MD, FACP	Ph:  515-244-7586 888-244-6061
	Des Moines General Hospital
		Roscoe Morton, MD, FACP	Ph:  515-247-3121
	John Stoddard Cancer Center at Iowa Lutheran Hospital
		Roscoe Morton, MD, FACP	Ph:  515-663-5612
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Roscoe Morton, MD, FACP	Ph:  515-241-4245
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Roscoe Morton, MD, FACP	Ph:  515-247-3121
	Onawa
	Burgess Health Center
		James Mailliard, MD	Ph:  712-423-2311
Kansas
	Wichita
	CCOP - Wichita
		Shaker Dakhil, MD	Ph:  316-268-5784
	Veterans Affairs Medical Center - Wichita
		Shaker Dakhil, MD	Ph:  316-685-2221
Louisiana
	New Orleans
	CCOP - Ochsner
		Carl G. Kardinal, MD	Ph:  504-842-3910
	MBCCOP - LSU Health Sciences Center
		Jill Gilbert, MD	Ph:  504-568-5613
			Email: jgilbe@lsuhsc.edu
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Arlene Forastiere, MD	Ph:  410-955-9818
			Email: af@jhmi.edu
Massachusetts
	Boston
	Beth Israel Deaconess Medical Center
		Michael Benjamin Atkins, MD	Ph:  617-667-1930
	Tufts - New England Medical Center
		John Erban, MD	Ph:  617-636-5147
			Email: jerban@tufts-nemc.org
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip Stella, MD	Ph:  877-590-5995
	Kalamazoo
	CCOP - Kalamazoo
		Raymond Lord, MD	Ph:  269-373-7488
			Email: rlord@wmcc.org
Minnesota
	Duluth
	CCOP - Duluth
		Robert Dalton, MD	Ph:  218-786-8364
			Email: rdalton@smdc.org
	Minneapolis
	University of Minnesota Cancer Center
		George Adams, MD	Ph:  612-625-2410 888-226-2376
			Email: adams002@umn.edu
	Veterans Affairs Medical Center - Minneapolis
		Markus Gapany, MD	Ph:  612-725-2000 ext. 3459
			Email: gapan001@maroon.tc.umn.edu
	Rochester
	Mayo Clinic Cancer Center
		Thomas Habermann, MD	Ph:  507-284-2511
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick Flynn, MD	Ph:  952-993-1517
			Email: patrick.flynn@usoncology.com
Nebraska
	Omaha
	CCOP - Missouri Valley Cancer Consortium
		James Mailliard, MD	Ph:  402-280-4364
			Email: jamailliard@mrcc.cc
	Veterans Affairs Medical Center - Omaha
		James Mailliard, MD	Ph:  402-280-5274
	Papillion
	Midlands Cancer Center at Midlands Community Hospital
		James Mailliard, MD	Ph:  402-593-3000
Nevada
	Las Vegas
	CCOP - Southern Nevada Cancer Research Foundation
		John Ellerton, MD, CM	Ph:  702-384-0013
			Email: k.vanwagenen@sncrf.org
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Camilo Fadul, MD	Ph:  603-650-6312 800-639-6918
			Email: Camilo.e.fadul@dartmouth.edu
New Jersey
	East Orange
	Veterans Affairs Medical Center - East Orange
		Basil Kasimis, MD, DSc	Ph:  973-676-1000 ext. 1544
			Email: Basil.Kasimis@med.va.gov
	Hackensack
	CCOP - Northern New Jersey
		Richard Rosenbluth, MD	Ph:  201-996-5917
	New Brunswick
	Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
		Joseph Aisner, MD	Ph:  732-235-7401
			Email: aisnerjo@umdnj.edu
New Mexico
	Albuquerque
	MBCCOP - University of New Mexico HSC
		Cynthia Cathcart, MD	Ph:  505-272-5688
New York
	Bronx
	Albert Einstein Clinical Cancer Center
		Joseph Sparano, MD	Ph:  718-904-2555
			Email: jsparano@montefiore.org
	MBCCOP-Our Lady of Mercy Cancer Center
		Peter Wiernik, MD	Ph:  718-920-1100
			Email: pwiernik@aol.com
	Brooklyn
	Veterans Affairs Medical Center - Brooklyn
		Andrea Wiesel Leaf, MD	Ph:  718-630-3691
	New York
	NYU School of Medicine's Kaplan Comprehensive Cancer Center
		Howard Hochster, MD	Ph:  212-731-5100
			Email: howard.hochster@med.nyu.edu
	Veterans Affairs Medical Center - New York
		Howard Hochster, MD	Ph:  212-652-1912
			Email: howard.hochster@med.nyu.edu
North Dakota
	Fargo
	CCOP - Merit Care Hospital
		Preston Steen, MD	Ph:  701-234-6161
Ohio
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Robert Dreicer, MD, FACP	Ph:  216-445-4623
	MetroHealth's Cancer Care Center at MetroHealth Medical Center
		Edward Mansour, MD	Ph:  216-778-4394
			Email: emansour@metrohealth.org
	Columbus
	CCOP - Columbus
		J. Kuebler, MD, PhD	Ph:  614-443-2267
	Toledo
	CCOP - Toledo Community Hospital
		Paul Schaefer, MD	Ph:  419-843-6147
Oklahoma
	Tulsa
	CCOP - Oklahoma
		James Lockhart, MD	Ph:  918-491-5878
Pennsylvania
	Danville
	CCOP - Geisinger Clinic and Medical Center
		Albert Bernath, MD	Ph:  570-271-6466
	Hershey
	Penn State Cancer Institute at Milton S. Hershey Medical Center
		Witold Rybka, MD, FRCPC	Ph:  717-531-1050
			Email: wrybka@med.hmc.psu.edu
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania Medical Center
		Daniel Haller, MD	Ph:  215-662-6318
	Fox Chase Cancer Center
		Lori Goldstein, MD	Ph:  215-728-2689 888-369-2571
			Email: lj_goldstein@fccc.edu
	Hahnemann University Hospital
		Pamela Ann Crilley, DO	Ph:  215-762-8547
	Pittsburgh
	Hillman Cancer Center at University of Pittsburgh Cancer Institute
		John Munn Kirkwood, MD	Ph:  412-692-4724
	Veterans Affairs Medical Center - Pittsburgh
		Timothy Carlos, MD	Ph:  412-688-6248
			Email: timothy.carlos@med.va.gov
	Wynnewood
	CCOP - MainLine Health
		Paul Gilman, MD	Ph:  610-645-2494
South Dakota
	Sioux Falls
	CCOP - Sioux Community Cancer Consortium
		Loren Tschetter, MD	Ph:  605-328-8044
			Email: cincod@siouxvalley.org
Tennessee
	Nashville
	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
		David Johnson, MD	Ph:  615-343-9454 800-811-8480
			Email: david.h.johnson@vanderbilt.edu
	Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
		Kenneth Hande, MD	Ph:  615-327-4751
Texas
	Temple
	CCOP - Scott and White Hospital
		Lucas Wong, MD	Ph:  254-724-1053
			Email: lwong@swmail.sw.org
Wisconsin
	Green Bay
	CCOP - St. Vincent Hospital Cancer Center, Green Bay
		Gerald Bayer, MD	Ph:  920-433-8889
	Madison
	University of Wisconsin Comprehensive Cancer Center
		James Stewart, MD	Ph:  608-265-8131 800-622-8922
			Email: stewart@biostat.wisc.edu
	Veterans Affairs Medical Center - Madison
		Mark Albertini, MD	Ph:  608-262-7017
	Marshfield
	CCOP - Marshfield Clinic Research Foundation
		Tarit Kumar Banerjee, MD, FACP	Ph:  715-387-5134
	Milwaukee
	Medical College of Wisconsin Cancer Center
		David Vesole, MD, PhD	Ph:  414-805-4626
			Email: dvesole@bmt.mcw.edu
	Veterans Affairs Medical Center - Milwaukee (Zablocki)
		Mohammed A. Raheem, MD	Ph:  414-384-2000
Australia
New South Wales
	Westmead
	Westmead Hospital
		Richard Kefford, MD, PhD	Ph:  61-2-9845-6033
Peru
	Lima
	Instituto de Enfermedades Neoplasicas
		Carlos Santiago Vallejos-Sologuren, MD	Ph:  51-14-499-137
			Email: postmaster@inen.sld.pe
Puerto Rico
	San Juan
	MBCCOP - San Juan
		Luis Baez-Diaz, MD	Ph:  787-641-3693
			Email: sjccop@prtc.net
	San Juan City Hospital
		Luis Baez-Diaz, MD	Ph:  787-641-3693
			Email: sjccop@prtc.net
	Veterans Affairs Medical Center - San Juan
		Luis Baez-Diaz, MD	Ph:  787-641-7582
			Email: sjccop@prtc.net
Republic of South Africa
	Pretoria
	Pretoria Academic Hospital
		Coenraad Slabber, MD	Ph:  27-12-354-1054

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