Paclitaxel in Treating Patients With Ovarian Stromal Cancer
Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy
6 other identifiers
interventional
31
2 countries
98
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2000
Longer than P75 for phase_2
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2000
CompletedStudy Start
First participant enrolled
November 20, 2000
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2016
CompletedResults Posted
Study results publicly available
March 5, 2020
CompletedMarch 5, 2020
February 1, 2020
15.7 years
September 11, 2000
February 18, 2020
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Probability of Complete Clinical Response
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
Up to 5 years
Secondary Outcomes (2)
Progression-free Survival
The period from study entry until disease progression, death or date of last contact
Overall Survival
The observed length of life from entry into the study to death or the date of last contact
Study Arms (1)
Treatment (paclitaxel)
EXPERIMENTALPatients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (98)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Banner Thunderbird Medical Center
Glendale, Arizona, 85306, United States
Banner-University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
Western Regional CCOP
Phoenix, Arizona, 85006, United States
Scottsdale Healthcare
Scottsdale, Arizona, 85251, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Long Beach Memorial Medical Center-Todd Cancer Institute
Long Beach, California, 90806, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Community Hospital of Los Gatos
Los Gatos, California, 95032, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, 94040, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Memorial University Medical Center
Savannah, Georgia, 31404, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, 60521, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, 40202, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Medical Center of Baton Rouge
Baton Rouge, Louisiana, 70816, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Keesler Medical Center
Keesler Air Force Base, Mississippi, 39534, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07753, United States
State University of New York Downstate Medical Center
Brooklyn, New York, 11203, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467-2490, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Brookview Research Incorporated
Winston-Salem, North Carolina, 27103, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, 45219, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
Lake University Ireland Cancer Center
Mentor, Ohio, 44060, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
South Carolina Oncology Associates PA
Columbia, South Carolina, 29210, United States
Southeast Gynecologic Oncology Associates
Knoxville, Tennessee, 37917, United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
MultiCare Auburn Medical Center
Auburn, Washington, 98001, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531, United States
Saint Francis Hospital
Federal Way, Washington, 98003, United States
Saint Clare Hospital
Lakewood, Washington, 98499, United States
Providence - Saint Peter Hospital
Olympia, Washington, 98506-5166, United States
Capital Medical Center
Olympia, Washington, 98507, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, 98372, United States
MultiCare Allenmore Hospital
Tacoma, Washington, 98405, United States
Northwest NCI Community Oncology Research Program
Tacoma, Washington, 98405, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Tohoku University School of Medicine
Sendai, Aoba-ku, 980-8574, Japan
Sapporo Medical College
Sapporo, Chuo-ku, 060-8556, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Iwate Medical University School of Medicine
Morioka, Iwate, 020-8505, Japan
Kagoshima City Hospital
Kagoshima, Kagoshima-ken, 890-8760, Japan
Kawasaki Medical School
Okayama-Ken, Kurashiki, 701-0192, Japan
Keio University
Shinjuku-ku, Tokyo, 160-8582, Japan
National Hospital Organization-Kobe Medical Center
Kobe, 654-0155, Japan
Shikoku Cancer Center
Matsuyama, 791-0280, Japan
National Kyushu Cancer Center
Minamiku, 811 1395, Japan
Jikei University School of Medicine
Minato-ku, Tokyo, 105-8461, Japan
Kindai University
Osaka, Osaka, 589 8511, Japan
Tottori University
Tottori, 680-8550, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The protocol listed an overall study accrual range of 30 to 37, therefore the study achieved this accrual range (n=31). One patient had an indeterminate response for the primary outcome.
Results Point of Contact
- Title
- Christopher Purdy on behalf of Mark Brady PhD
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Linda Van Le
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2000
First Posted
January 27, 2003
Study Start
November 20, 2000
Primary Completion
July 16, 2016
Study Completion
July 16, 2016
Last Updated
March 5, 2020
Results First Posted
March 5, 2020
Record last verified: 2020-02