Ovarian Gynandroblastoma Clinical Trial
Official title:
Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy
Verified date | February 2020 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | July 16, 2016 |
Est. primary completion date | July 16, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Japan | Kagoshima City Hospital | Kagoshima City | Kagoshima |
Japan | National Hospital Organization-Kobe Medical Center | Kobe | |
Japan | Shikoku Cancer Center | Matsuyama | |
Japan | National Kyushu Cancer Center | Minami-ku | |
Japan | Jikei University School of Medicine | Minato-ku, Tokyo | |
Japan | Iwate Medical University School of Medicine | Morioka | Iwate |
Japan | Kawasaki Medical School | Okayama-Ken | Kurashiki |
Japan | Kindai University | Osaka, Osaka | |
Japan | Hokkaido University Hospital | Sapporo | Hokkaido |
Japan | Sapporo Medical College | Sapporo | Chuo-ku |
Japan | Tohoku University School of Medicine | Sendai | Aoba-ku |
Japan | Keio University | Shinjuku-ku | Tokyo |
Japan | Tottori University | Tottori | |
United States | Abington Memorial Hospital | Abington | Pennsylvania |
United States | Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania |
United States | MultiCare Auburn Medical Center | Auburn | Washington |
United States | Rush - Copley Medical Center | Aurora | Illinois |
United States | Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana |
United States | Medical Center of Baton Rouge | Baton Rouge | Louisiana |
United States | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama |
United States | Montefiore Medical Center - Moses Campus | Bronx | New York |
United States | Montefiore Medical Center-Einstein Campus | Bronx | New York |
United States | State University of New York Downstate Medical Center | Brooklyn | New York |
United States | Cooper Hospital University Medical Center | Camden | New Jersey |
United States | Aultman Health Foundation | Canton | Ohio |
United States | Providence Regional Cancer System-Centralia | Centralia | Washington |
United States | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina |
United States | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina |
United States | University of Virginia Cancer Center | Charlottesville | Virginia |
United States | Rush University Medical Center | Chicago | Illinois |
United States | University of Cincinnati/Barrett Cancer Center | Cincinnati | Ohio |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | MetroHealth Medical Center | Cleveland | Ohio |
United States | South Carolina Oncology Associates PA | Columbia | South Carolina |
United States | Mount Carmel Health Center West | Columbus | Ohio |
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Union Hospital of Cecil County | Elkton | Maryland |
United States | Saint Francis Hospital | Federal Way | Washington |
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
United States | Banner Thunderbird Medical Center | Glendale | Arizona |
United States | North Colorado Medical Center | Greeley | Colorado |
United States | Hartford Hospital | Hartford | Connecticut |
United States | Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania |
United States | Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale | Illinois |
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 | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Joliet Oncology-Hematology Associates Limited | Joliet | Illinois |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Keesler Medical Center | Keesler Air Force Base | Mississippi |
United States | Kettering Medical Center | Kettering | Ohio |
United States | Southeast Gynecologic Oncology Associates | Knoxville | Tennessee |
United States | Wilford Hall Medical Center | Lackland Air Force Base | Texas |
United States | Saint Clare Hospital | Lakewood | Washington |
United States | Women's Cancer Center of Nevada | Las Vegas | Nevada |
United States | Beebe Medical Center | Lewes | Delaware |
United States | University of Kentucky/Markey Cancer Center | Lexington | Kentucky |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Long Beach Memorial Medical Center-Todd Cancer Institute | Long Beach | California |
United States | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California |
United States | Community Hospital of Los Gatos | Los Gatos | California |
United States | Norton Hospital Pavilion and Medical Campus | Louisville | Kentucky |
United States | McKee Medical Center | Loveland | Colorado |
United States | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio |
United States | University of Tennessee Health Science Center | Memphis | Tennessee |
United States | Lake University Ireland Cancer Center | Mentor | Ohio |
United States | Franciscan Saint Anthony Health-Michigan City | Michigan City | Indiana |
United States | West Virginia University Healthcare | Morgantown | West Virginia |
United States | Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View | California |
United States | Jersey Shore Medical Center | Neptune | New Jersey |
United States | The Hospital of Central Connecticut | New Britain | Connecticut |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Capital Medical Center | Olympia | Washington |
United States | Providence - Saint Peter Hospital | Olympia | Washington |
United States | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California |
United States | Temple University Hospital | Philadelphia | Pennsylvania |
United States | Banner-University Medical Center Phoenix | Phoenix | Arizona |
United States | Western Regional CCOP | Phoenix | Arizona |
United States | MultiCare Good Samaritan Hospital | Puyallup | Washington |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | UCSF Medical Center-Mount Zion | San Francisco | California |
United States | Memorial University Medical Center | Savannah | Georgia |
United States | Scottsdale Healthcare | Scottsdale | Arizona |
United States | MultiCare Allenmore Hospital | Tacoma | Washington |
United States | Northwest NCI Community Oncology Research Program | Tacoma | Washington |
United States | Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa | Oklahoma |
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 |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States, Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Progression-free Survival | Duration of progression free survival (median) (months) | The period from study entry until disease progression, death or date of last contact | |
Secondary | Overall Survival | Duration of overall survival (median) (months) | The observed length of life from entry into the study to death or the date of last contact |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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