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

Alternate Title

Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active Not specified NCI GOG-174 ECOG-G174

Special Category: NIH Clinical Center trial

Objectives

1. Compare the efficacy of methotrexate vs dactinomycin, as measured by complete response rate, in patients with low-risk gestational trophoblastic neoplasia.
2. Compare the toxicity of these regimens in these patients.
3. Determine whether the definition of persistent gestational trophoblastic neoplasia is accurate (as determined by the likelihood that the beta human chorionic gonadotropin [HCG] titer would decline on the day treatment is initiated).

Entry Criteria

Disease Characteristics:

• Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following:
  • Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers
  • Greater than 20% sustained rise in beta HCG titer over two consecutive weeks
  • Persistently elevated beta HCG titer more than 4 months after initial curettage (greater than 5 mIU/mL minimum)
  • Histologically proven nonmetastatic choriocarcinoma
  • Metastases to vagina, parametria, or lung (if no single pulmonary lesion is greater than 2 cm)



• WHO score 0-6 (not including blood group or CT lung)



• No histologically confirmed placental site pseudotumor



• Must have undergone at least 1 uterine curettage



• Previously untreated disease

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for gestational trophoblastic neoplasia

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics
• No concurrent curettage except as needed to control vaginal bleeding or to rule out placental site pseudotumor

Patient Characteristics:

Age:

• Not specified

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGPT and SGOT no greater than 3 times ULN
• Alkaline phosphatase no greater than 3 times ULN
• No significant prior abnormal hepatic function

Renal:

• Creatinine no greater than 2.0 mg/dL
• No significant prior abnormal renal function

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for one year after study entry
• No other prior or concurrent malignancies within the past 5 years except nonmelanomatous skin cancer

Projected Accrual

A total of 216 patients will be accrued for this study within 4 years.

Outline

This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity.



• Arm II: Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity.

All patients continue on treatment until 1 beta human chorionic gonadotropin (HCG) titer is below the institutional normal. Each patient then receives 1 additional consolidation treatment.

Patients are followed every 4 weeks for 1 year.

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

Gynecologic Oncology Group

Raymond Osborne, MD, Protocol chair		Ph: 416-480-4026 Email: ray.osborne@tsrcc.on.ca

U.S.A.
Alabama
	Birmingham
	University of Alabama at Birmingham Comprehensive Cancer Center
		Carla Falkson, MD	Ph:  205-975-2691
			Email: cfalkson@uab.edu
		Mack Barnes, MD	Ph:  205-934-5077
Arizona
	Phoenix
	CCOP - Western Regional, Arizona
		David King, MD, FACP	Ph:  602-239-2413
			Email: david.king@baannerhealth.com
California
	Los Gatos
	Women's Cancer Center at Community Hospital of Los Gatos
		Nick Spirtos, MD	Ph:  408-866-3843
			Email: nspirtos@wccenter.com
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
		Robert Burger, MD	Ph:  714-456-7971
			Email: raburger@uci.edu
Colorado
	Denver
	University of Colorado Cancer Center at University of Colorado Health Sciences Center
		Francis Major, MD	Ph:  303-388-4876 800-473-2288
			Email: francis.major@usoncology.com
Delaware
	Newark
	CCOP - Christiana Care Health Services
		Stephen Grubbs, MD	Ph:  302-623-4100
Hawaii
	Honolulu
	MBCCOP - Hawaii
		Brian Issell, MD	Ph:  808-586-3015
			Email: brian@crch.hawaii.edu
Illinois
	Chicago
	MBCCOP - University of Illinois at Chicago
		Lawrence Feldman, MD	Ph:  312-335-3614
	University of Chicago Cancer Research Center
		S. Diane Yamada, MD	Ph:  773-702-6722 888-824-0200
			Email: sdyamada@babies.bsd.uchicago.edu
	Decatur
	CCOP - Central Illinois
		L. Massad, MD	Ph:  217-545-8882
	Evanston
	CCOP - Evanston
		Gershon Locker, MD, FACP	Ph:  847-570-2518
			Email: glocker@enh.org
	Urbana
	CCOP - Carle Cancer Center
		Kendrith Rowland, MD	Ph:  217-383-4083
			Email: kendrith.rowland@carle.com
Indiana
	Indianapolis
	Indiana University Cancer Center
		Katherine Look, MD	Ph:  317-274-8987 888-600-4822
			Email: klook@iupui.edu
		Patrick Loehrer, MD	Ph:  317-278-7418 888-600-4822
	South Bend
	CCOP - Northern Indiana CR Consortium
		Rafat Ansari, MD, FACP	Ph:  574-284-7977 800-284-7370
	Saint Joseph Regional Medical Center
		Michael Method, MD, MPH	Ph:  574-237-8010
			Email: mmethod@mhopc.com
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Joel Sorosky, MD	Ph:  319-356-2015
			Email: joel-sorosky@uiowa.edu
Kentucky
	Lexington
	Markey Cancer Center at University of Kentucky Chandler Medical Center
		Frederick Ueland, MD	Ph:  606-257-1613
			Email: fredueland@yahoo.com
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
		NCI Clinical Studies Support	Ph:  888-NCI-1937
Massachusetts
	Boston
	Tufts - New England Medical Center
		John Erban, MD	Ph:  617-636-5147
			Email: jerban@tufts-nemc.org
		Kenneth Noller, MD	Ph:  617-636-2382
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip Stella, MD	Ph:  877-590-5995
			Email: beekmanl@trinity-health.org
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Gunter Deppe, MD	Ph:  313-745-7286 800-527-6266
			Email: gdeppe@med.wayne.edu
	Grand Rapids
	CCOP - Grand Rapids
		Kathleen Yost, MD	Ph:  616-391-1230
			Email: kathleen.yost@grcop.org
	Kalamazoo
	CCOP - Kalamazoo
		Raymond Lord, MD	Ph:  269-373-7488
			Email: rlord@wmcc.org
Minnesota
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick Flynn, MD	Ph:  952-993-1517
			Email: patrick.flynn@usoncology.com
Mississippi
	Jackson
	University of Mississippi Medical Center
		James Thigpen, MD	Ph:  601-984-5590
			Email: jthigpen@medicine.umsmed.edu
Missouri
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Jeffrey Bloss, MD	Ph:  317-651-2677
	Kansas City
	CCOP - Kansas City
		Jorge Paradelo, MD	Ph:  816-823-0555
			Email: kccop@kccop.org
	Springfield
	CCOP - Cancer Research for the Ozarks
		John Goodwin, MD	Ph:  417-269-4520
			Email: jwg684@sprg.mercy.net
Nebraska
	Omaha
	CCOP - Missouri Valley Cancer Consortium
		James Mailliard, MD	Ph:  402-280-4364
			Email: jamailliard@mrcc.cc
New Jersey
	Camden
	Cooper University Hospital
		David Warshal, MD	Ph:  856-342-2185 800-8-COOPER
			Email: warshal-david@cooperhealth.edu
	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 York
	Buffalo
	Roswell Park Cancer Institute
		Shashikant B. Lele, MD	Ph:  716-845-5776 800-767-9355
			Email: shashi.lele@roswellpark.org
	New York
	NYU School of Medicine's Kaplan Comprehensive Cancer Center
		Howard Hochster, MD	Ph:  212-731-5100
			Email: howard.hochster@med.nyu.edu
	Stony Brook
	Long Island Cancer Center at Stony Brook University Hospital
		Michael Pearl, MD	Ph:  631-444-2774 800-UMC-2215
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Wesley Fowler, MD	Ph:  919-966-1196
			Email: wfowler@med.unc.edu
	Durham
	Duke Comprehensive Cancer Center
		Daniel Clarke-Pearson, MD	Ph:  919-684-3765
	Winston-Salem
	Comprehensive Cancer Center at Wake Forest University
		Brigitte Miller, MD	Ph:  336-716-6673
			Email: bemiller@wfubmc.edu
Ohio
	Cincinnati
	Charles M. Barrett Cancer Center at University Hospital
		Nader Husseinzadeh, MD	Ph:  513-558-8450
			Email: nallerhusseinzadeh@uc.edu
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Peter Rose, MD	Ph:  216-444-1712
			Email: rosep@ccf.org
		Robert Dreicer, MD, FACP	Ph:  216-445-4623
	MetroHealth's Cancer Care Center at MetroHealth Medical Center
		Steven Waggoner, MD	Ph:  216-844-5011 800-641-2422
	Columbus
	Arthur G. James Cancer Hospital at Ohio State University
		Jeffrey Fowler, MD	Ph:  614-293-8737 800-293-5066
Oklahoma
	Oklahoma City
	University of Oklahoma College of Medicine
		Robert Mannel, MD	Ph:  405-271-8787
			Email: robert-mannel@ouhsc.edu
Oregon
	Portland
	CCOP - Columbia River Oncology Program
		Keith Lanier, MD	Ph:  503-216-6260
Pennsylvania
	Abington
	Abington Memorial Hospital
		Parviz Hanjani, MD	Ph:  215-885-0220
			Email: phanjani@amh.org
	Danville
	CCOP - Geisinger Clinic and Medical Center
		Nava Siegelmann-Danieli, MD	Ph:  570-271-6834
			Email: nsdanieli@geisinger.edu
	Hershey
	Penn State Cancer Institute at Milton S. Hershey Medical Center
		George Olt, MD	Ph:  717-531-8144
		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
		Mark Morgan, MD	Ph:  215-662-6043
	Fox Chase Cancer Center
		Lori Goldstein, MD	Ph:  215-728-2689 888-369-2571
			Email: lj_goldstein@fccc.edu
		Michael Bookman, MD	Ph:  215-728-2987 888-369-2571
			Email: ma_bookman@fccc.edu
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Norman Rosenblum, MD, PhD	Ph:  215-955-6200 800-533-3669
	Pittsburgh
	UPMC Cancer Center at Magee-Womens Hospital
		Joseph Kelley, MD	Ph:  412-641-5418
			Email: jkelley@mail.magee.edu
Tennessee
	Knoxville
	Southeast Gynecologic Oncology Associates
		Kenneth Cofer, MD	Ph:  865-673-9250
	Nashville
	Gynecologic Oncology Network
		Howard Homesley, MD	Ph:  615-804-2216
			Email: hdh7173@aol.com
	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
		Marta Crispens, MD	Ph:  615-322-2114 800-811-8480
			Email: marta.crispens@vanderbilt.edu
Texas
	Dallas
	Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
		David Miller, MD	Ph:  214-648-3026
			Email: david.miller@utsouthwestern.edu
	Galveston
	University of Texas Medical Branch
		Edward Hannigan, MD	Ph:  409-772-3368
			Email: edward.hanniga@utmb.edu
	Temple
	CCOP - Scott and White Hospital
		Lucas Wong, MD	Ph:  254-724-1053
			Email: lwong@swmail.sw.org
Washington
	Tacoma
	Multicare Medical Center
		Roger Lee, MD	Ph:  253-403-1029
			Email: rogerblee@aol.com
Wisconsin
	Madison
	University of Wisconsin Comprehensive Cancer Center
		James Stewart, MD	Ph:  608-265-8131 800-622-8922
			Email: stewart@biostat.wisc.edu
		Julian Schink, MD	Ph:  608-263-8600 800-622-8922
Canada
Alberta
	Calgary
	Tom Baker Cancer Center - Calgary
		Gavin Stuart, MD	Ph:  403-944-1721
			Email: gavinst@cancerboard.ab.ca
Ontario
	Toronto
	Toronto Sunnybrook Regional Cancer Centre
		Raymond Osborne, MD	Ph:  416-480-4026
			Email: ray.osborne@tsrcc.on.ca
Republic of South Africa
	Pretoria
	Pretoria Academic Hospital
		Coenraad Slabber, MD	Ph:  27-12-354-1054

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