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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02054 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| GOG #0187 | |||
| CDR0000068149 | |||
| GOG-0187 | |||
| GOG-0187 | Other Identifier | NRG Oncology | |
| GOG-0187 | Other Identifier | CTEP | |
| U10CA180868 | U.S. NIH Grant/Contract | View source | |
| U10CA027469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (paclitaxel) | Experimental | Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Duration of progression free survival (median) (months) | The period from study entry until disease progression, death or date of last contact |
| Overall Survival | Duration of overall survival (median) (months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Van Le | NRG Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | United States | ||
| Banner Thunderbird Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Paclitaxel: Given IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| The observed length of life from entry into the study to death or the date of last contact |
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Paclitaxel: Given IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Eligible and evaluable | Posted | Number | 80% Confidence Interval | Percentage of Participants | Up to 5 years |
|
|
| |||||||||||||||||||||||||
| Secondary | Progression-free Survival | Duration of progression free survival (median) (months) | Posted | Median | 80% Confidence Interval | Months | The period from study entry until disease progression, death or date of last contact |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | Duration of overall survival (median) (months) | Posted | Median | 80% Confidence Interval | Months | The observed length of life from entry into the study to death or the date of last contact |
|
|
For the duration of treatment and follow-up
Adverse events were defined according to CTC v2.0 for the period of protocol activation through March 31, 2010. Beginning on April 1, 2010 adverse events were defined according to CTCAE v4.0.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Paclitaxel: Given IV | 16 | 31 | 1 | 31 | 31 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | CTC (2.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTC (2.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTC (2.0) | Systematic Assessment |
| |
| Thrombocytopenia | Investigations | CTC (2.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTC (2.0) | Systematic Assessment |
| |
| Cardiovascular | Cardiac disorders | CTC (2.0) | Systematic Assessment |
| |
| Constitutional | General disorders | CTC (2.0) | Systematic Assessment |
| |
| Dermatologic | Skin and subcutaneous tissue disorders | CTC (2.0) | Systematic Assessment |
| |
| Gastrointestinal | Gastrointestinal disorders | CTC (2.0) | Systematic Assessment |
| |
| Genitourinary | Renal and urinary disorders | CTC (2.0) | Systematic Assessment |
| |
| Hepatic | Hepatobiliary disorders | CTC (2.0) | Systematic Assessment |
| |
| Infection / fever | Infections and infestations | CTC (2.0) | Systematic Assessment |
| |
| Neurologic | Injury, poisoning and procedural complications | CTC (2.0) | Systematic Assessment |
| |
| Metabolic | Metabolism and nutrition disorders | CTC (2.0) | Systematic Assessment |
| |
| Musculoskeletal | Musculoskeletal and connective tissue disorders | CTC (2.0) | Systematic Assessment |
| |
| Ocular | Eye disorders | CTC (2.0) | Systematic Assessment |
| |
| Pain | General disorders | CTC (2.0) | Systematic Assessment |
| |
| Pulmonary | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Systematic Assessment |
|
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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Purdy on behalf of Mark Brady PhD | NRG Oncology | (716)845-1300 | 2296 | purdyc@nrgoncology.org |
| ID | Term |
|---|---|
| C538459 | Ovarian gynandroblastoma |
| D018310 | Sertoli-Leydig Cell Tumor |
| ID | Term |
|---|---|
| D018312 | Sex Cord-Gonadal Stromal Tumors |
| D018309 | Neoplasms, Gonadal Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D013736 | Testicular Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D013733 | Testicular Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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| Title | Measurements |
|---|
|
| >= 60 |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Denominators | Categories |
|---|
|
| Title | Denominators | Categories |
|---|
|