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Home > "P" Clinical Trials Conditions > Paclitaxel in Treating Patients With Ovarian Stromal Cancer Paclitaxel in Treating Patients With Ovarian Stromal Cancer
Paclitaxel in Treating Patients With Ovarian Stromal Cancer
For Condition: ovarian stromal cancer
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have ovarianstromal cancer.
Details: OBJECTIVES: - Determine the clinical response to paclitaxel in patients with ovarian stromal cancer. - Determine toxicity of this drug in these patients. - Determine the value of inhibin for predicting response in these patients when treated with this regimen. 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. PROJECTED ACCRUAL: A total of 29-79 patients (15-37 with prior treatment and 14-42 without prior treatment) will be accrued for this study within 4.4-5.3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol 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 - Previously untreated disease diagnosed within past 8 weeks OR - Recurrent disease after no more than 1 prior chemotherapy regimen - Measurable disease - At least 1 cm in diameter PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - GOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardHomesley, Study Chair, Gynecologic Oncology Network
Rush-Presbyterian-St. Luke's Medical Center *Recruiting*
Chicago, Illinois, 60612-3824
United States
Recruiting Howard Strassner 312-942-6723
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Kathleen Yost 616-391-1230
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7295
United States
Recruiting Wesley Fowler 919-966-1196
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Mack Barnes 205-934-0930
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Anthony Evans 715-389-3101
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536-0084
United States
Recruiting Frederick Ueland 606-257-1613
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
Tacoma General Hospital *Recruiting*
Tacoma, Washington, 98405
United States
Recruiting Roger Lee 253-403-1029
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 1-888-NCI-1937
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Nava Siegelmann-Danieli 570-271-6834
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati, Ohio, 45267-0526
United States
Recruiting Nader Husseinzadeh 513-558-8450
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44124
United States
Recruiting Peter Rose 216-444-1712
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Gunnar Kristensen 47-22-934-000
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting James Thigpen 601-984-5590
Saint Joseph Regional Medical Center *Recruiting*
South Bend, Indiana, 46617
United States
Recruiting Michael Method 574-237-8010
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting David Mutch 314-362
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange, California, 92868
United States
Recruiting Robert Burger 714-456-7971
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62794-9640
United States
Recruiting L. Massad 217-545-8882
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1740
United States
Recruiting Jonathan Berek 310-206-5161
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Katherine Look 317-274-8987
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103-1489
United States
Recruiting David Warshal 856-342-2185
Abington Memorial Hospital *Recruiting*
Abington, Pennsylvania, 19001-3788
United States
Recruiting Parviz Hanjani 215-885-0220
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Mark Morgan 215-662-6043
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Gynecologic Oncology Network *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Howard Homesley 615-804-2216
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1002
United States
Recruiting Joel Sorosky 319-356-2015
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting George Olt 717-531-8144
Long Island Cancer Center at Stony Brook University Hospital *Recruiting*
Stony Brook, New York, 11790-7775
United States
Recruiting Michael Pearl 631-444-2774
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0587
United States
Recruiting Edward Hannigan 409-772-3368
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Sara Crowder 573-882-1057
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Steven Waggoner 216-844-5011
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107-5541
United States
Recruiting Stephanie King 215-762-2640
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Jeffrey Fowler 614-293-8737
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
University of Oklahoma College of Medicine *Recruiting*
Oklahoma City, Oklahoma, 73190
United States
Recruiting Robert Mannel 405-271-8787
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-2516
United States
Recruiting Marta Crispens 615-322-2114
Magee-Womens Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15213-3180
United States
Recruiting Joseph Kelley 412-641-5418
Women's Cancer Center at Community Hospital of Los Gatos *Recruiting*
Los Gatos, California, 95032
United States
Recruiting Nick Spirtos 408-866-3843
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
Southeast Gynecologic Oncology Associates *Recruiting*
Knoxville, Tennessee, 37917
United States
Recruiting Kenneth Cofer 865-673-9250
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1065
United States
Recruiting Brigitte Miller 336-716-6673
Additional Information:
Study ID Numbers: CDR0000068149; GOG-0187
Study Start Date:
Record last reviewed: March 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006227
Other Ovarian Stromal Cancer Studies:
1. Paclitaxel in Treating Patients With Ovarian Stromal Cancer
Related Studies:
Other ovarian stromal cancer Clinical Trials
Other Missouri Clinical Trials
Other Springfield Clinical Trials
Paclitaxel in Treating Patients With Ovarian Stromal Cancer
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