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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02659 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| GOG-0127W | |||
| CDR0000691281 | |||
| GOG-0127W | Other Identifier | NRG Oncology | |
| GOG-0127W | 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 |
|---|---|
| NRG Oncology | OTHER |
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This phase II clinical trial is studying the how well veliparib, topotecan hydrochloride, and filgrastim or pegfilgrastim work in treating patients with persistent or recurrent cervical cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by blocking them from dividing. Giving veliparib with chemotherapy may kill more tumor cells. Filgrastim or pegfilgrastim may cause the body to make more blood cells and help it recover from the side effects of chemotherapy.
PRIMARY OBJECTIVES:
I. To estimate the antitumor activity (objective response rate by RECIST 1.1) of ABT-888 (veliparib) 10 mg administered orally twice a day on days 1 to 5 with topotecan (topotecan hydrochloride) 0.6 mg/m^2 administered IV once daily on days 1 to 5 of each cycle in patients with persistent or recurrent carcinoma of the cervix.
II. To determine the nature and degree of toxicity of ABT-888 and topotecan in patients with persistent or recurrent carcinoma of the cervix.
SECONDARY OBJECTIVES:
I. To determine the duration of progression-free survival and overall survival.
TERTIARY OBJECTIVES:
I. To determine whether evidence of an interaction exists between study treatments and tumor expression of poly(ADP-ribos)ylation of E2 protein, E6/E7 proteins, and p53R2 in relation to progression-free and overall survival or metastasis. (Translational) II. To explore the association between methylation of FanCF and BRCA in pre-treatment tumor samples and pre- and post-treatment biopsy samples and response, progression-free and overall survival of patients, and/or metastasis. (Translational)
OUTLINE:
Patients receive veliparib orally (PO) twice daily and topotecan hydrochloride intravenously (IV) over 30 minutes once daily on days 1-5. Patients also receive, according to institutional standard, filgrastim subcutaneously (SC) beginning on day 6, 7, or 8 and continuing until hematopoietic recovery or pegfilgrastim SC on day 6, 7, or 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples may be collected periodically for translational studies.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (veliparib, topotecan hydrochloride, filgrastim) | Experimental | Patients receive veliparib PO twice daily and topotecan hydrochloride IV over 30 minutes once daily on days 1-5. Patients also receive, according to institutional standard, filgrastim SC beginning on day 6, 7, or 8 and continuing until hematopoietic recovery or pegfilgrastim SC on day 6, 7, or 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgrastim | Biological | Given SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | Complete and Partial Tumor Response as Assessed by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation. | Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicted based on symptoms or physical signs suggestive of progressive disease. The average time was 2.3 months |
| Number of Patients With Dose-limiting Toxicities (in Safety lead-in) | A dose-limiting toxicity (DLT) is assessed by NCI CTCAE v4, occurring during cycle 1 of therapy.: A dose-limiting toxicity (DLT) is defined as either hematologic or non-hematologic toxicity assessed by NCI CTCAE v4, occurring during cycle 1 of therapy, which cause any of the following: For hematologic toxicity - dose delay of greater than 2 weeks due to failure to recover counts, Treatment related febrile neutropenia, grade 4 neutropenia lasting >7 days, treatment related grade 4 thrombocytopenia or clinically significant bleeding with grade 3 thrombocytopenia. For non-hematologic toxicity; study treatment related grade 3 or 4 non-hematological toxicity (excluding anorexia, constipation, fatigue, hypersensitivity/allergic reaction to one of the study drugs, nausea & vomiting, and grade 3 dehydration), grade 4 nausea and vomiting for >48 hours despite maximum medical management, electrolyte imbalance of > or equal to grade 3 that can be replaced within 48 hours; any drug related death | Up to 21 days |
| Adverse Events (Grade 3 or Higher) During Treatment Period | Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0. | During treatment period and up to 30 days after stopping the study treatment.The average of study treatment time was 2.3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Kunos | NRG Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States | ||
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The study was activated on 2/7/2011 and closed to accrual on 1/17/2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT-888, Topotecan and Filgrastim or Pegfilgrastim | ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Pegfilgrastim | Biological | Given SC |
|
|
| Topotecan Hydrochloride | Drug | Given IV |
|
|
| Veliparib | Drug | Given PO |
|
|
| From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up. |
| Overall Survival | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. | From study entry to death or last contact, up to 5 years of follow-up. |
| Duration of Objective Response | Duration of objective response is defined as the duration from the time measurement criteria is met for partial or complete response by RECIST 1.1, whichever is first recorded, until the first date the recurrent or progressive disease is objectively documented. Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation. | Every other cycle for first 6 months; then every 3 months until disease progression confirmed; and at any other time if clinically indicated based on symptoms or signs suggestive of progressive disease.The average of study treatment time was 2.3 months. |
| University of Colorado Cancer Center - Anschutz Cancer Pavilion |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | 06105 | United States |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | United States |
| Florida Hospital Orlando | Orlando | Florida | 32803 | United States |
| Memorial University Medical Center | Savannah | Georgia | 31404 | United States |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale | Illinois | 60521 | United States |
| Memorial Medical Center | Springfield | Illinois | 62781 | United States |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106-0995 | United States |
| Michigan Cancer Research Consortium CCOP | Ann Arbor | Michigan | 48106 | United States |
| Oakwood Hospital and Medical Center | Dearborn | Michigan | 48124 | United States |
| Saint John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| Hurley Medical Center | Flint | Michigan | 48502 | United States |
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
| Allegiance Health | Jackson | Michigan | 49201 | 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 |
| Sparrow Hospital | Lansing | Michigan | 48912 | United States |
| Saint Mary Mercy Hospital | Livonia | Michigan | 48154 | United States |
| Saint Joseph Mercy Oakland | Pontiac | Michigan | 48341 | United States |
| Saint Joseph Mercy Port Huron | Port Huron | Michigan | 48060 | United States |
| Saint Mary's of Michigan | Saginaw | Michigan | 48601 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Cancer Research for the Ozarks NCORP | Springfield | Missouri | 65804 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | 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 |
| Southwest Gynecologic Oncology Associates Inc | Albuquerque | New Mexico | 87106 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | United States |
| State University of New York Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| North Shore-LIJ Health System/Center for Advanced Medicine | New Hyde Park | New York | 11040 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | 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 |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | United States |
| University Medical Center Brackenridge | Austin | Texas | 78701 | United States |
| Parkland Memorial Hospital | Dallas | Texas | 75235 | United States |
| Zale Lipshy University Hospital | Dallas | Texas | 75235 | United States |
| Clements University Hospital | Dallas | Texas | 75390 | United States |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | United States |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | United States |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | United States |
| PeaceHealth Medical Group PC | Bellingham | Washington | 98226 | United States |
| Harrison HealthPartners Hematology and Oncology-Bremerton | Bremerton | Washington | 98310 | United States |
| Harrison Medical Center | Bremerton | Washington | 98310 | United States |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | United States |
| Skagit Valley Hospital Regional Cancer Care Center | Mount Vernon | Washington | 98273 | United States |
| Harrison HealthPartners Hematology and Oncology-Poulsbo | Poulsbo | Washington | 98370 | United States |
| Pacific Gynecology Specialists | Seattle | Washington | 98104 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Group Health Cooperative-Seattle | Seattle | Washington | 98112 | United States |
| Swedish Medical Center-First Hill | Seattle | Washington | 98122-4307 | United States |
| Northwest Hospital | Seattle | Washington | 98133 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Olympic Medical Cancer Care Center | Sequim | Washington | 98384 | United States |
| Cancer Care Northwest - Spokane South | Spokane | Washington | 99202 | United States |
| Rockwood Cancer Treatment Center-DHEC-Downtown | Spokane | Washington | 99204 | United States |
| MultiCare Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| Saint Joseph Medical Center | Tacoma | Washington | 98405 | United States |
| Providence Saint Mary Regional Cancer Center | Walla Walla | Washington | 99362 | United States |
| Wenatchee Valley Hospital and Clinics | Wenatchee | Washington | 98801 | United States |
| D N Greenwald Center | Mukwonago | Wisconsin | 53149 | United States |
| Oconomowoc Memorial Hospital-ProHealth Care Inc | Oconomowoc | Wisconsin | 53066 | United States |
| Waukesha Memorial Hospital | Waukesha | Wisconsin | 53188 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Eligible and treated patients
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| ID | Title | Description |
|---|---|---|
| BG000 | ABT-888, Topotecan and Filgrastim or Pegfilgrastim | ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Tumor Response | Complete and Partial Tumor Response as Assessed by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation. | Eligible and Treated Patients | Posted | Number | 90% Confidence Interval | percentage of participants | Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicted based on symptoms or physical signs suggestive of progressive disease. The average time was 2.3 months |
|
|
| |||||||||||||||||||||||||
| Primary | Number of Patients With Dose-limiting Toxicities (in Safety lead-in) | A dose-limiting toxicity (DLT) is assessed by NCI CTCAE v4, occurring during cycle 1 of therapy.: A dose-limiting toxicity (DLT) is defined as either hematologic or non-hematologic toxicity assessed by NCI CTCAE v4, occurring during cycle 1 of therapy, which cause any of the following: For hematologic toxicity - dose delay of greater than 2 weeks due to failure to recover counts, Treatment related febrile neutropenia, grade 4 neutropenia lasting >7 days, treatment related grade 4 thrombocytopenia or clinically significant bleeding with grade 3 thrombocytopenia. For non-hematologic toxicity; study treatment related grade 3 or 4 non-hematological toxicity (excluding anorexia, constipation, fatigue, hypersensitivity/allergic reaction to one of the study drugs, nausea & vomiting, and grade 3 dehydration), grade 4 nausea and vomiting for >48 hours despite maximum medical management, electrolyte imbalance of > or equal to grade 3 that can be replaced within 48 hours; any drug related death | The first 6 eligible and treated patients who completed the 1st cycle of study treatment or had a DLT prior to completing the first cycle of study treatment | Posted | Number | participants | Up to 21 days |
| ||||||||||||||||||||||||||||
| Primary | Adverse Events (Grade 3 or Higher) During Treatment Period | Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0. | Eligible and treated patients - No statistical analysis provided for adverse events (grade 3 or higher) during treatment period. | Posted | Number | Participants | During treatment period and up to 30 days after stopping the study treatment.The average of study treatment time was 2.3 months. |
|
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression. | Eligible and Treated Patients | Posted | Median | 95% Confidence Interval | months | From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up. |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. | Eligible and Treated Patients | Posted | Median | 95% Confidence Interval | months | From study entry to death or last contact, up to 5 years of follow-up. |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Objective Response | Duration of objective response is defined as the duration from the time measurement criteria is met for partial or complete response by RECIST 1.1, whichever is first recorded, until the first date the recurrent or progressive disease is objectively documented. Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation. | Eligible and Treated Patients with objective response | Posted | Median | Full Range | Months | Every other cycle for first 6 months; then every 3 months until disease progression confirmed; and at any other time if clinically indicated based on symptoms or signs suggestive of progressive disease.The average of study treatment time was 2.3 months. |
|
During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
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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 | ABT-888, Topotecan and Filgrastim or Pegfilgrastim | ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1. | 16 | 27 | 27 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Failure | Cardiac disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Upper Gastrointestinal Hemorrhage | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Small Intestinal Perforation | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Death Nos | General disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Infections And Infestations - Other | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Neoplasms Benign, Malignant And Unspecified (Incl | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 4.0 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Respiratory, Thoracic And Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Surgical And Medical Procedures - Other | Surgical and medical procedures | CTCAE 4.0 | Non-systematic Assessment |
| |
| Thromboembolic Event | Vascular disorders | CTCAE 4.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Heart Failure | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ear And Labyrinth Disorders - Other | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Endocrine Disorders - Other | Endocrine disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Salivary Duct Inflammation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rectal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mucositis Oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lower Gastrointestinal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hemorrhoidal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| General Disorders And Administration Site Conditio | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Localized Edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema Limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Infections And Infestations - Other | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Upper Respiratory Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vaginal Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lip Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight Loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight Gain | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Inr Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ggt Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Creatinine Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| White Blood Cell Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alkaline Phosphatase Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Activated Partial Thromboplastin Time Prolonged | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Musculoskeletal Deformity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Musculoskeletal And Connective Tissue Disorder - | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral Motor Neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depressed Level Of Consciousness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cystitis Noninfective | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vaginal Hemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vaginal Discharge | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Postnasal Drip | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin And Subcutaneous Tissue Disorders - Other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Erythema Multiforme | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vascular Disorders - Other | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thromboembolic Event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hot Flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Gedeon, Clinical Data Coordinator | NRG Oncology | 716-845-1169 | lgedeon@gogstats.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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| C455861 | pegfilgrastim |
| D019772 | Topotecan |
| C521013 | veliparib |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|