Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Paclitaxel in Treating Patients With Ovarian Stromal Cancer

Basic Trial Information

Objectives

1. Determine the clinical response to paclitaxel in patients with ovarian stromal cancer.
2. Determine toxicity of this drug in these patients.
3. Determine the value of inhibin for predicting response in these patients when treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed ovarian stromal cancer not amenable to surgery
  • Granulosa cell tumor
  • Granulosa cell theca cell tumor
  • Sertoli-Leydig cell tumor (androblastoma)
  • Gynandroblastoma
  • Unclassified sex cord stromal tumor
  • Sex cord tumor with annular tubules
  • Steroid (lipid) cell tumor

• Recurrent disease after no more than 1 prior chemotherapy regimen

• Measurable disease
  • At least 1 cm in diameter

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to study lesion

Surgery:

• See Disease Characteristics

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 normal
• SGOT no greater than 3 times normal

Renal:

• Creatinine no greater than 2.0 mg/dL

Other:

• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other prior invasive malignancy in past 5 years except nonmelanoma skin cancer

Expected Enrollment

A total of 45 patients will be accrued for this study.

Outcomes

Frequency of complete clinical response

Duration of progression-free survival
Overall survival

Outline

This is a multicenter study. Patients are stratified according to prior treatment (yes vs no).

Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.

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

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Linda Van Le, MD, Protocol chair		Ph: 919-966-5996 Email: lvl@med.unc.edu

U.S.A.
California
	Long Beach
	Todd Cancer Institute at Long Beach Memorial Medical Center
		Robert Bristow	Ph:  562-933-0900
	Mountain View
	Palo Alto Medical Foundation
		Albert Pisani	Ph:  650-934-7000
Connecticut
	New Britain
	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
		Clinical Trials Office - George Bray Cancer Center	Ph:  860-224-5660
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-623-4450
Hawaii
	Honolulu
	MBCCOP - Hawaii
		Jeffrey Berenberg, MD	Ph:  808-433-4089
Illinois
	Hinsdale
	Gynecologic Oncology
		Sudarshan Sharma, MD	Ph:  630-856-6757
Indiana
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
		Clinical Trials Office - Indiana University Cancer Center	Ph:  317-274-2552
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
Kentucky
	Lexington
	Lucille P. Markey Cancer Center at University of Kentucky
		Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center	Ph:  859-257-3379
	Louisville
	Louisville Oncology at Norton Cancer Institute - Louisville
		Clinical Trials Office - Louisville Oncology	Ph:  502-629-2500
Maryland
	Elkton MD
	Union Hospital of Cecil County
		Mark Borowsky	Ph:  410-398-4000
Michigan
	Kalamazoo
	Borgess Medical Center
		Raymond Lord, MD	Ph:  269-373-7458
	Bronson Methodist Hospital
		Raymond Lord, MD	Ph:  269-373-7458
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		James Thigpen, MD	Ph:  601-984-5590
Nevada
	Las Vegas
	Women's Cancer Center - La Canada
		Nick Spirtos, MD	Ph:  408-866-3843
New York
	Brooklyn
	SUNY Downstate Medical Center
		Ovadia Abulafia, MD	Ph:  718-270-2152
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Center	Ph:  877-668-0683; 919-966-4432
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center	Ph:  704-355-2884
	Durham
	Duke Cancer Institute
		Clinical Trials Office - Duke Cancer Institute	Ph:  888-275-3853
Ohio
	Canton
	Aultman Cancer Center at Aultman Hospital
		Clinical Trials Office - Aultman Cancer Center at Aultman Hospital	Ph:  330-363-6891
	Cincinnati
	Charles M. Barrett Cancer Center at University Hospital
		William Richards	Ph:  806-796-1317
	Cleveland
	Cleveland Clinic Cancer Center at Fairview Hospital
		Clinical Trials Office - Cleveland Clinic Cancer Center at Fairview Hospital	Ph:  216-476-9362
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Peter Rose, MD	Ph:  216-444-1712
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph:  866-627-7616
			Email: osu@emergingmed.com
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
	Mayfield Heights
	Hillcrest Cancer Center at Hillcrest Hospital
		Peter Rose, MD	Ph:  216-444-1712
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Robert Mannel, MD	Ph:  405-271-8787
	Tulsa
	Cancer Care Associates - Saint Francis Campus
		Robert Mannel, MD	Ph:  405-271-8787
Pennsylvania
	Abington
	Rosenfeld Cancer Center at Abington Memorial Hospital
		Clinical Trials Office - Rosenfeld Cancer Center at Abington Memorial Hospital	Ph:  215-481-2402
	Allentown
	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
		Richard Boulay, MD	Ph:  610-402-3650
	Hershey
	Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
		Clinical Trials Office - Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center	Ph:  717-531-3779
			Email: CTO@hmc.psu.edu
	Philadelphia
	Fox Chase Cancer Center CCOP Research Base
		Clinical Trials Office - Fox Chase Cancer Center CCOP Research Base	Ph:  215-728-2983
South Carolina
	Columbia
	South Carolina Oncology Associates, PA
		James Williams, MD	Ph:  803-461-3000
Virginia
	Charlottesville
	University of Virginia Cancer Center
		Susan Modesitt	Ph:  434-924-9333 800-223-9173
Japan
	Kagoshima City, Kagoshima
	Kagoshima City Hospital
		Masayuki Hatae, MD	Ph:  81-99-224-2101
	Kure
	National Hospital Organization - Medical Center of Kure
		Kazuhiro Takehara	Ph:  81-82-322-3111
	Matsuyama
	Shikoku Cancer Center
		Masamichi Hiura, MD	Ph:  81-89-999-1111
	Osaka, Osaka
	Kinki University School of Medicine
		Yoh Watanabe	Ph:  81-723-66-0221
	Sapporo
	Hokkaido University Hospital
		Noriaki Sakuragi	Ph:  81-11-716-1161 ext. 6000
	Sendai
	Tohoku University Graduate School of Medicine
		Nobuo Yaegashi	Ph:  81-22-274-1111
	Shinjuku-ku
	Keio University School of Medicine
		Nobuyuki Susumu, MD	Ph:  81-3-3353-1211ext.62275
	Tottori
	Tottori University Hospital
		Junzo Kigawa, MD, PhD	Ph:  81-859-33-1111
Iwate
	Morioka
	Iwate Medical University Hospital
		Toru Sugiyama	Ph:  81-19-651-5111

Registry Information
Official Title		Phase II Study of Paclitaxel for Ovarian Stromal Tumors as First-Line or Second-Line Therapy
Trial Start Date		2000-11-20
Registered in ClinicalTrials.gov		NCT00006227
Date Submitted to PDQ		2000-07-10
Information Last Verified		2012-02-10
NCI Grant/Contract Number		CA27469

Back to Top