Paclitaxel in Treating Patients With Ovarian Stromal Cancer
Adult Type Ovarian Granulosa Cell Tumor, Ovarian Gynandroblastoma, Ovarian Sertoli-Leydig Cell Tumor
About this trial
This is an interventional treatment trial for Adult Type Ovarian Granulosa Cell Tumor
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with histologically confirmed ovarian stromal tumor (granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor [androblastoma], steroid [lipid] cell tumor, gynandroblastoma, unclassified sex cord stromal tumor, sex cord tumor with annular tubules) Patients must have recurrent stromal tumor having received no more than one prior chemotherapy regimen Patients must have measurable disease as defined by Gynecological Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria White blood count equal to or greater than 3000/mcl Granulocyte count equal to or greater than 1500/mcl Platelet count equal to or greater than 100,000/mcl Creatinine equal to or less than 2.0 mg% Bilirubin less than or equal to 1.5 times normal Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 times normal Patients with a GOG performance grade of 0, 1 or 2 Patients of child bearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control Patients who have met the pre-entry requirements as specified Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization Exclusion Criteria: Patients with GOG performance grade of 3 or 4 Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy Patients having received more than one prior chemotherapy regimen Patients amenable to cure by surgery Patients with prior radiation except for those whose recurrent disease is outside the radiation port
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Banner Thunderbird Medical Center
- Banner-University Medical Center Phoenix
- Western Regional CCOP
- Scottsdale Healthcare
- University of Arkansas for Medical Sciences
- Long Beach Memorial Medical Center-Todd Cancer Institute
- UCLA / Jonsson Comprehensive Cancer Center
- Community Hospital of Los Gatos
- Palo Alto Medical Foundation-Gynecologic Oncology
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- UCSF Medical Center-Mount Zion
- North Colorado Medical Center
- McKee Medical Center
- Hartford Hospital
- The Hospital of Central Connecticut
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- Memorial University Medical Center
- Rush - Copley Medical Center
- Rush University Medical Center
- Sudarshan K Sharma MD Limted-Gynecologic Oncology
- Joliet Oncology-Hematology Associates Limited
- Indiana University/Melvin and Bren Simon Cancer Center
- Saint Vincent Hospital and Health Care Center
- Franciscan Saint Anthony Health-Michigan City
- University of Iowa/Holden Comprehensive Cancer Center
- University of Kentucky/Markey Cancer Center
- Norton Hospital Pavilion and Medical Campus
- Mary Bird Perkins Cancer Center
- Medical Center of Baton Rouge
- Union Hospital of Cecil County
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- University of Mississippi Medical Center
- Keesler Medical Center
- Washington University School of Medicine
- Women's Cancer Center of Nevada
- Cooper Hospital University Medical Center
- Jersey Shore Medical Center
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center - Moses Campus
- State University of New York Downstate Medical Center
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Duke University Medical Center
- Brookview Research Incorporated
- Novant Health Forsyth Medical Center
- Novant Health Oncology Specialists
- Wake Forest University Health Sciences
- Aultman Health Foundation
- University of Cincinnati/Barrett Cancer Center
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Riverside Methodist Hospital
- Mount Carmel Health Center West
- Kettering Medical Center
- Hillcrest Hospital Cancer Center
- Lake University Ireland Cancer Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Abington Memorial Hospital
- Lehigh Valley Hospital-Cedar Crest
- Penn State Milton S Hershey Medical Center
- Temple University Hospital
- South Carolina Oncology Associates PA
- Southeast Gynecologic Oncology Associates
- University of Tennessee Health Science Center
- Brooke Army Medical Center
- Wilford Hall Medical Center
- University of Virginia Cancer Center
- MultiCare Auburn Medical Center
- Providence Regional Cancer System-Centralia
- Saint Francis Hospital
- Saint Clare Hospital
- Providence - Saint Peter Hospital
- Capital Medical Center
- MultiCare Good Samaritan Hospital
- MultiCare Allenmore Hospital
- Northwest NCI Community Oncology Research Program
- West Virginia University Healthcare
- Tohoku University School of Medicine
- Sapporo Medical College
- Hokkaido University Hospital
- Iwate Medical University School of Medicine
- Kagoshima City Hospital
- Kawasaki Medical School
- Keio University
- National Hospital Organization-Kobe Medical Center
- Shikoku Cancer Center
- National Kyushu Cancer Center
- Jikei University School of Medicine
- Kindai University
- Tottori University
Arms of the Study
Arm 1
Experimental
Treatment (paclitaxel)
Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.