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

Alternate Title

Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Gynecologic Malignancy

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Active 18 and over NCI GOG-0192

Special Category: NIH Clinical Center trial

Objectives

1. Determine, preliminarily, whether amifostine is superior to no treatment, in terms of improving the symptoms and/or objective findings of platinum-induced peripheral neuropathy, in patients with gynecologic malignancies.
2. Determine the toxicity of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Prior therapy with a platinum (cisplatin or carboplatin)-based chemotherapy regimen for a gynecologic malignancy
  • Treatment with other agents, including paclitaxel, allowed



• Grade 2 or greater peripheral neuropathy (numbness, tingling, pain in the distal extremities) attributed to prior platinum-based chemotherapy
  • Must have persisted and be stable for 3-36 months after completion of chemotherapy
  • Duration of neuropathy no more than 3 years



• No other possible causes for the neuropathy (e.g., alcoholism, diabetes, or peripheral vascular disease)

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• No concurrent chemotherapy
• No chemotherapy (including paclitaxel, cisplatin, and carboplatin) for at least 4 months after study entry

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 24 hours since prior antihypertensive medications
• No prior amifostine
• Prior treatment on a GOG treatment protocol allowed
• No concurrent monoamine oxidase inhibitors
• No concurrent neurotoxic agents during and for at least 6 months after study entry

Patient Characteristics:

Age

• 18 and over

Performance status

• GOG 0-3

Life expectancy

• At least 6 months

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 2.0 mg/dL

Renal

• Creatinine no greater than 2.0 mg/dL
• Calcium at least lower limit of normal

Cardiovascular

• No hypotension
• No history of cerebrovascular accident

Other

• No other significant comorbid medical conditions that would preclude study participation

Projected Accrual

A total of 50-100 patients (25-50 per treatment arm) will be accrued for this study.

Outline

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

• Arm I: Patients receive amifostine IV over 3 minutes on days 1, 3, and 5. Treatment continues for 12 weeks in the absence of unacceptable toxicity. Patients are observed for 12 weeks.



• Arm II: Patients are observed for 24 weeks. After 24 weeks patients may cross over to treatment as in arm I.

Quality of life is assessed at baseline and then at 6, 12, 18, and 24 weeks after study entry.

Patients are followed at 6 and 12 weeks after study treatment, 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

Steven C. Plaxe, MD, Protocol chair		Ph: 619-543-6905

U.S.A.
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
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
Connecticut
	New Haven
	Yale Comprehensive Cancer Center
		Peter E. Schwartz, MD	Ph:  203-785-4014
			Email: peter.schwartz@yale.edu
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
	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
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
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
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Sara Crowder, MD	Ph:  573-882-1057
			Email: crowders@health.missouri.edu
	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
	Buffalo
	Roswell Park Cancer Institute
		Shashikant B. Lele, MD	Ph:  716-845-5776 800-767-9355
			Email: shashi.lele@roswellpark.org
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
Ohio
	Cincinnati
	Charles M. Barrett Cancer Center at University Hospital
		Nader Husseinzadeh, MD	Ph:  513-558-8450
			Email: nallerhusseinzadeh@uc.edu
	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
	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
	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
Japan
	Kagoshima City
	Kagoshima City Hospital
		Masayuki Hatae, MD	Ph:  81-99-224-2101

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