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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-0127U | |||
| CDR0000372930 | Other Identifier | CDR |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well topotecan works in treating women with persistent or recurrent cervical cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patient are followed for every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 1-2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topotecan | Experimental | Topotecan weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topotecan hydrochloride | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate. | CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years. |
| Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | All participants assessed by CTCAE v3 (Common Terminology Criteria for Adverse Events version 3.0) including grade 0 (the number of participants not affected by the Adverse Event). | Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up |
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DISEASE CHARACTERISTICS:
Histologically confirmed carcinoma of the cervix
Measurable disease
Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent squamous cell or nonsquamous cell carcinoma of the cervix
Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following:
At least 3 weeks since prior biologic or immunologic agents for cervical cancer
No concurrent prophylactic growth factors, including filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim
No concurrent prophylactic thrombopoietic agents
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| James V. Fiorica, MD | Sarasota Memorial Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19726073 | Result | Fiorica JV, Blessing JA, Puneky LV, Secord AA, Hoffman JS, Yamada SD, Buekers TE, Bell J, Schilder JM; Gynecologic Oncology Group. A Phase II evaluation of weekly topotecan as a single agent second line therapy in persistent or recurrent carcinoma of the cervix: a Gynecologic Oncology Group study. Gynecol Oncol. 2009 Nov;115(2):285-9. doi: 10.1016/j.ygyno.2009.07.024. Epub 2009 Sep 2. |
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This trial was opened to patient entry on January 3, 2005 and was closed to accrual on October 29, 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Topotecan Hydrochloride | Topotecan hydrochloride 3.0 mg/m² IV over 30 minutes every 7 days for 21 days; 7 days off (cycle = 28 days) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Kaiser Permanente Medical Center - Los Angeles |
| Los Angeles |
| California |
| 90027 |
| United States |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States |
| Olive View - UCLA Medical Center Foundation | Sylmar | California | 91342 | United States |
| Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford | Connecticut | 06102-5037 | United States |
| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain | Connecticut | 06050 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06520-8028 | United States |
| Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland | Florida | 33805 | United States |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | 31403-3089 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | 48073 | United States |
| University of Mississippi Cancer Clinic | Jackson | Mississippi | 39216 | United States |
| Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi | 39581 | United States |
| Saint Louis University Cancer Center | St Louis | Missouri | 63110 | United States |
| Methodist Estabrook Cancer Center | Omaha | Nebraska | 68114 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210-1240 | United States |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214-3998 | United States |
| Mount Carmel Health - West Hospital | Columbus | Ohio | 43222 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Cancer Care Associates - Midtown Tulsa | Tulsa | Oklahoma | 74104 | United States |
| Women and Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| COMPLETED | Eligible and treated patients |
|
| NOT COMPLETED |
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Eligible and treated patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Topotecan Hydrochloride | Topotecan hydrochloride 3.0 mg/m² IV over 30 minutes every 7 days for 21 days; 7 days off (cycle = 28 days) |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
| ||||||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate. | Eligible and treated patients with sufficient follow-up assessments to evaluate response | Posted | Number | participants | CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years. |
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| Primary | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | All participants assessed by CTCAE v3 (Common Terminology Criteria for Adverse Events version 3.0) including grade 0 (the number of participants not affected by the Adverse Event). | Eligible and treated patients | Posted | Number | participants | Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up |
|
Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
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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 | Topotecan Hydrochloride | Topotecan hydrochloride 3.0 mg/m² IV over 30 minutes every 7 days for 21 days; 7 days off (cycle = 28 days) | 9 | 25 | 25 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Death No Ctcae Term - Death Nos (Not Otherwise Specified) | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Infection with Normal Or Grade 1 Or 2 Absolute Neutrophil Count: Lung (Pneumonia) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
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| Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
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| Central nervous system ischemia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Diplopia | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pain: Extremity-Limb | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pain: Back | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Stricture, Anastomotic, Genitourinary - Ureter | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis/Thrombus/Embolism | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Transfusions | Blood and lymphatic system disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Hemorrhage | Vascular disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Nausea/Vomiting | Gastrointestinal disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Other gastrointestinal | Gastrointestinal disorders | CTCAE V3.0 | Non-systematic Assessment |
| |
| Genito urinary | Renal and urinary disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Neurotoxicity | Nervous system disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Pain | General disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Pulmonary | Respiratory, thoracic and mediastinal disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Infection | Infections and infestations | CTCAE V3.0 | Non-systematic Assessment |
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| Constitutional | General disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Metabolic | Metabolism and nutrition disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Dermatologic | Skin and subcutaneous tissue disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Renal | Renal and urinary disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Alkaline phosphatase | Investigations | CTCAE V3.0 | Non-systematic Assessment |
| |
| Vascular | Vascular disorders | CTCAE V3.0 | Non-systematic Assessment |
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| Lymphatics | Blood and lymphatic system disorders | CTCAE V3.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE V3.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Kuras on behalf of James Kauderer | NRG Oncology | 716-845-5702 | kurasa@nrgoncology.org |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Title | Measurements |
|---|---|
|
| 60-69 years |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG004 | Grade 4 (CTCAE v 3.0) | Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE). |
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