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

Alternate Title

Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over NCI GOG-0204

Special Category: NIH Clinical Center trial

Objectives

1. Compare the survival and response of patients with stage IVB, recurrent, or persistent carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin.
2. Compare the toxic effects of these regimens in these patients.
3. Compare the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
  • Stage IVB, recurrent, or persistent disease



• Not amenable to curative surgery and/or radiotherapy



• At least 1 unidimensionally measurable lesion
  • At least 20 mm by palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan
  • Biopsy confirmation required if lesion is less than 30 mm
  • Target lesion must be outside of a previously irradiated field



• No craniospinal metastases

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent cytokines

Chemotherapy

• At least 6 weeks since prior chemoradiotherapy and recovered
• No prior chemotherapy (except when concurrently administered with radiotherapy)

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• See Chemotherapy
• At least 3 weeks since prior radiotherapy and recovered

Surgery

• Recovered from prior surgery

Patient Characteristics:

Age

• 18 and over

Performance status

• GOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 times normal
• Alkaline phosphatase no greater than 3 times normal
• AST no greater than 3 times normal

Renal

• Creatinine no greater than 1.2 mg/dL

  OR

• Creatinine greater than 1.2 mg/dL but less than 1.5 mg/dL AND creatinine clearance greater than 50 mL/min
• No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous drainage

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer
• No prior malignancy whose treatment contraindicates the current study therapy
• No concurrent clinically significant infection

Projected Accrual

A total of 600 patients (150 per treatment arm) will be accrued for this study within 4 years.

Outline

This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.

• Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.



• Arm II: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.



• Arm III: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.



• Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before courses 2 and 5, and at 9 months after study entry.

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

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

Bradley J. Monk, MD, Protocol chair		Ph: 714-456-6570 Email: bjmonk@uci.edu

U.S.A.
Alabama
	Birmingham
	University of Alabama at Birmingham Comprehensive Cancer Center
		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 Angeles
	Jonsson Comprehensive Cancer Center, UCLA
		Jonathan Berek, MD	Ph:  310-206-5161
	Los Gatos
	Women's Cancer Center at Community Hospital of Los Gatos
		Nick Spirtos, MD	Ph:  408-866-3843
			Email: nspirtos@wccenter.com
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
	Rush University Medical Center
		Howard Strassner, MD	Ph:  312-942-6723
	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
	South Bend
	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
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
		NCI Clinical Studies Support	Ph:  888-NCI-1937
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip Stella, MD	Ph:  877-590-5995
	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
	Keesler AFB
	Keesler Medical Center - Keesler Air Force Base
		John Bomalaski, MD	Ph:  228-377-6396
			Email: john.bomalaski@keesler.af.mil
Missouri
	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 York
	New York
	Memorial Sloan-Kettering Cancer Center
		Carol L. Brown, MD	Ph:  212-639-7659
	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
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
	Ireland Cancer 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
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania Medical Center
		Mark Morgan, MD	Ph:  215-662-6043
	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
	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
	Houston
	University of Texas - MD Anderson Cancer Center
		Charles Levenback, MD	Ph:  713-745-2563 800-392-1611
			Email: clevenba@mdanderson.org
	Temple
	CCOP - Scott and White Hospital
		Lucas Wong, MD	Ph:  254-724-1053
			Email: lwong@swmail.sw.org
Virginia
	Charlottesville
	Cancer Center at the University of Virginia
		Willie Albert Andersen, MD	Ph:  434-924-9333 800-223-9173
Washington
	Tacoma
	Multicare Medical Center
		Roger Lee, MD	Ph:  253-403-1029
			Email: rogerblee@aol.com
Wisconsin
	Madison
	University of Wisconsin Comprehensive Cancer Center
		Ellen Hartenbach, MD	Ph:  608-263-1209 800-622-8922
	Marshfield
	CCOP - Marshfield Clinic Research Foundation
		Anthony Evans, MD, PhD	Ph:  715-387-5161
			Email: evans.anthony@marshfieldclinic.org

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