Paclitaxel in Treating Patients With Ovarian Stromal Cancer
- Conditions
- Adult Type Ovarian Granulosa Cell TumorOvarian GynandroblastomaOvarian Sex Cord Tumor With Annular TubulesOvarian Sertoli-Leydig Cell TumorOvarian Steroid Cell Tumor
- Interventions
- Registration Number
- NCT00006227
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
This phase II trial studies the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
- Detailed Description
PRIMARY OBJECTIVES:
I. To estimate the probability of clinical response and toxicity of paclitaxel as second-line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma.
II. To evaluate the value of inhibin for predicting response.
OUTLINE:
Patients receive paclitaxel intravenously (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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 31
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (paclitaxel) 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.
- Primary Outcome Measures
Name Time Method Probability of Complete Clinical Response Up to 5 years The probability of complete clinical response (i.e. proportion of participants) (assessed using GOG RECIST criteria) of paclitaxel as second line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma
- Secondary Outcome Measures
Name Time Method Progression-free Survival The period from study entry until disease progression, death or date of last contact Duration of progression free survival (median) (months)
Overall Survival The observed length of life from entry into the study to death or the date of last contact Duration of overall survival (median) (months)
Trial Locations
- Locations (98)
Palo Alto Medical Foundation-Gynecologic Oncology
🇺🇸Mountain View, California, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Mount Carmel Health Center West
🇺🇸Columbus, Ohio, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Iowa/Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Scottsdale Healthcare
🇺🇸Scottsdale, Arizona, United States
Community Hospital of Los Gatos
🇺🇸Los Gatos, California, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
University of Kentucky/Markey Cancer Center
🇺🇸Lexington, Kentucky, United States
UCLA / Jonsson Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Memorial University Medical Center
🇺🇸Savannah, Georgia, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Rush - Copley Medical Center
🇺🇸Aurora, Illinois, United States
Long Beach Memorial Medical Center-Todd Cancer Institute
🇺🇸Long Beach, California, United States
Christiana Care Health System-Christiana Hospital
🇺🇸Newark, Delaware, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Lehigh Valley Hospital-Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Franciscan Saint Anthony Health-Michigan City
🇺🇸Michigan City, Indiana, United States
Hillcrest Hospital Cancer Center
🇺🇸Mayfield Heights, Ohio, United States
Banner Thunderbird Medical Center
🇺🇸Glendale, Arizona, United States
Medical Center of Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Joliet Oncology-Hematology Associates Limited
🇺🇸Joliet, Illinois, United States
Cooper Hospital University Medical Center
🇺🇸Camden, New Jersey, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Aultman Health Foundation
🇺🇸Canton, Ohio, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Penn State Milton S Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Sapporo Medical College
🇯🇵Sapporo, Chuo-ku, Japan
Kindai University
🇯🇵Osaka, Osaka, Japan
South Carolina Oncology Associates PA
🇺🇸Columbia, South Carolina, United States
Indiana University/Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center
🇺🇸Indianapolis, Indiana, United States
Union Hospital of Cecil County
🇺🇸Elkton, Maryland, United States
University of Alabama at Birmingham Cancer Center
🇺🇸Birmingham, Alabama, United States
Western Regional CCOP
🇺🇸Phoenix, Arizona, United States
UCSF Medical Center-Mount Zion
🇺🇸San Francisco, California, United States
Banner-University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
Women's Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati/Barrett Cancer Center
🇺🇸Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Iwate Medical University School of Medicine
🇯🇵Morioka, Iwate, Japan
Jikei University School of Medicine
🇯🇵Minato-ku, Tokyo, Japan
McKee Medical Center
🇺🇸Loveland, Colorado, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
The Hospital of Central Connecticut
🇺🇸New Britain, Connecticut, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology
🇺🇸Hinsdale, Illinois, United States
Jersey Shore Medical Center
🇺🇸Neptune, New Jersey, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Keesler Medical Center
🇺🇸Keesler Air Force Base, Mississippi, United States
State University of New York Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Carolinas Medical Center/Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Cleveland Clinic Cancer Center/Fairview Hospital
🇺🇸Cleveland, Ohio, United States
Lake University Ireland Cancer Center
🇺🇸Mentor, Ohio, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
🇺🇸Tulsa, Oklahoma, United States
Southeast Gynecologic Oncology Associates
🇺🇸Knoxville, Tennessee, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
University of Tennessee Health Science Center
🇺🇸Memphis, Tennessee, United States
Wilford Hall Medical Center
🇺🇸Lackland Air Force Base, Texas, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
MultiCare Auburn Medical Center
🇺🇸Auburn, Washington, United States
Providence Regional Cancer System-Centralia
🇺🇸Centralia, Washington, United States
Saint Francis Hospital
🇺🇸Federal Way, Washington, United States
Saint Clare Hospital
🇺🇸Lakewood, Washington, United States
MultiCare Allenmore Hospital
🇺🇸Tacoma, Washington, United States
Providence - Saint Peter Hospital
🇺🇸Olympia, Washington, United States
MultiCare Good Samaritan Hospital
🇺🇸Puyallup, Washington, United States
Capital Medical Center
🇺🇸Olympia, Washington, United States
Northwest NCI Community Oncology Research Program
🇺🇸Tacoma, Washington, United States
West Virginia University Healthcare
🇺🇸Morgantown, West Virginia, United States
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Tohoku University School of Medicine
🇯🇵Sendai, Aoba-ku, Japan
Kagoshima City Hospital
🇯🇵Kagoshima City, Kagoshima, Japan
Kawasaki Medical School
🇯🇵Okayama-Ken, Kurashiki, Japan
National Kyushu Cancer Center
🇯🇵Minami-ku, Japan
Keio University
🇯🇵Shinjuku-ku, Tokyo, Japan
National Hospital Organization-Kobe Medical Center
🇯🇵Kobe, Japan
Shikoku Cancer Center
🇯🇵Matsuyama, Japan
Tottori University
🇯🇵Tottori, Japan
Norton Hospital Pavilion and Medical Campus
🇺🇸Louisville, Kentucky, United States
Montefiore Medical Center-Einstein Campus
🇺🇸Bronx, New York, United States
Montefiore Medical Center - Moses Campus
🇺🇸Bronx, New York, United States
UNC Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Brookview Research Incorporated
🇺🇸Winston-Salem, North Carolina, United States
Novant Health Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Novant Health Oncology Specialists
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States