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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02707 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000528257 | |||
| GOG-0170I | Other Identifier | Gynecologic Oncology Group | |
| GOG-0170I | Other Identifier | CTEP | |
| U10CA027469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Gynecologic Oncology Group | NETWORK |
This phase II trial is studying the side effects and how well temsirolimus works in treating patients with refractory or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
OBJECTIVES: Primary I. Determine the 6-month progression-free survival (PFS) or objective tumor response in patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with temsirolimus.
II. Determine the toxicity of this drug in these patients.
Secondary I. Determine the duration of PFS and overall survival of these patients.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (temsirolimus) | Experimental | Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temsirolimus | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 Month Progression-free Survival (PFS) | Number of participants who survived progression-free for more than 6 months. | 6 months |
| Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is 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. Increasing Disease is at least a 20% increase in the sum of LD of target lesions, taking as references the smallest sum LD or the appearance of new lesions. | Up to 5 years |
| Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Progression-free Survival | Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. |
| Measure | Description | Time Frame |
|---|---|---|
| Reason Off Study Therapy | from study entry until end of study treatment | |
| Patient Vital Status | Patients alive or dead after 24 months from time of study entry | Study entry up to 2 years |
Inclusion Criteria:
Histologically confirmed ovarian epithelial, fallopian tube or primary peritoneal cavity cancer
Prior treatment with ≥ 1 platinum-based chemotherapeutic regimen for management of primary disease (containing carboplatin, cisplatin, or another organoplatinum compound) required
Initial treatment may have included any of the following:
Patients must meet ≥ 1 of the following criteria:
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Must have ≥ 1 target lesion
Not eligible for a higher priority GOG protocol, if one exists
GOG performance status (PS) 0-2 for patients who have receive one prior regimen OR GOG PS 0-1 for patients who have received 2-3 prior regimens
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Creatinine ≤ 1.5 times upper limit normal (ULN)
Bilirubin ≤ 1.5 times ULN
AST ≤ 2.5 times ULN
Alkaline phosphatase ≤ 2.5 times ULN
No neuropathy (sensory and motor) > grade 2
Fasting cholesterol < 350 mg/dL
Fasting triglycerides < 400 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active infection requiring antibiotics (with the exception of uncomplicated UTI)
No other invasive malignancies within the past 5 years, except for non-melanoma skin cancer, breast cancer, or head and neck cancer
See Disease Characteristics
Recovered from prior surgery, radiotherapy, or chemotherapy
At least 1 week since prior hormonal therapy directed at the malignant tumor
At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin
At least 3 years since prior adjuvant chemotherapy for localized breast cancer
At least 3 weeks since other prior therapy directed at the malignant tumor, including immunologic agents
No prior temsirolimus
No prior cancer treatment that would preclude study therapy
No prior radiotherapy to > 25% of marrow-bearing areas
No prior radiotherapy to any portion of the abdominal cavity or pelvis, except for the treatment of ovarian cancer
No prior non-cytotoxic therapy for management of recurrent or persistent ovarian disease, except for therapy that was part of the primary treatment regimen
Two additional cytotoxic regimens (defined as any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa) for management of recurrent or persistent ovarian disease allowed
Concurrent low molecular weight heparin allowed provided PT/INR ≤ 1.5
Concurrent hormone replacement therapy allowed
No concurrent amifostine or other protective reagents
No concurrent prophylactic filgrastim (G-CSF)
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| Name | Affiliation | Role |
|---|---|---|
| Kian Behbakht | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21752435 | Derived | Behbakht K, Sill MW, Darcy KM, Rubin SC, Mannel RS, Waggoner S, Schilder RJ, Cai KQ, Godwin AK, Alpaugh RK. Phase II trial of the mTOR inhibitor, temsirolimus and evaluation of circulating tumor cells and tumor biomarkers in persistent and recurrent epithelial ovarian and primary peritoneal malignancies: a Gynecologic Oncology Group study. Gynecol Oncol. 2011 Oct;123(1):19-26. doi: 10.1016/j.ygyno.2011.06.022. Epub 2011 Jul 12. | |
| 19238149 | Derived |
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Patients were required to have had one regimen of a platinum agent for the treatment of ovarian cancer. Patients entering the study therefore were required to have either persistent or recurrent cancer that was measurable by RECIST.
Patients were accrued to the first stage of accrual from 2/5/07 to 9/4/07. Patients were accrued to the second stage of accrual between 5/7/08 to 8/25/08. They received 25 mg IV of CCI-779 weekly. One cycle was 28 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Temsirolimus) | Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months up to 5 years |
| Duration of Overall Survival | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. | Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years. |
| Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583. |
| COMPLETED |
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| NOT COMPLETED |
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Number of eligible and evaluable participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Temsirolimus) | Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| International Federation of Gynecology and Obstetrics (FIGO) Recurrent/Persistent Disease | Number | participants |
| |||||||||||||||||||||||
| Cell Type | Number | 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 | 6 Month Progression-free Survival (PFS) | Number of participants who survived progression-free for more than 6 months. | Posted | Number | participants | 6 months |
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| |||||||||||||||||||||||||||
| Primary | Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is 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. Increasing Disease is at least a 20% increase in the sum of LD of target lesions, taking as references the smallest sum LD or the appearance of new lesions. | Posted | Number | participants | Up to 5 years |
|
| ||||||||||||||||||||||||||||
| Primary | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Eligible and evaluable patients. | Posted | Count of Participants | Participants | Up to 5 years |
| |||||||||||||||||||||||||||||
| Secondary | Duration of Progression-free Survival | Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. | Eligible and evaluable patients | Posted | Median | Inter-Quartile Range | months | CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months up to 5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of 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 evaluable patients. | Posted | Median | Inter-Quartile Range | months | Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years. |
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| Other Pre-specified | Reason Off Study Therapy | Posted | Number | participants | from study entry until end of study treatment |
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| Other Pre-specified | Patient Vital Status | Patients alive or dead after 24 months from time of study entry | Posted | Number | participants | Study entry up to 2 years |
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All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
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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 (Temsirolimus) | Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | 5 | 54 | 44 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (3.0) |
| ||
| Insomnia | General disorders | CTCAE (3.0) |
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| Death No Ctcae Term - Disease Progression Nos | General disorders | CTCAE (3.0) |
| ||
| Ileus | Gastrointestinal disorders | CTCAE (3.0) |
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| Obstruction, Gi - Small Bowel Nos | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) |
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| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Memory Impairment | Nervous system disorders | CTCAE (3.0) |
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| Pain: Head/Headache | General disorders | CTCAE (3.0) |
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| Pain: Abdominal Pain Nos | General disorders | CTCAE (3.0) |
| ||
| Pulmonary: Other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
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| Obstruction, Gu - Bladder | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Thrombosis/Thrombus/Embolism | Vascular disorders | CTCAE (3.0) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) |
| ||
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) |
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| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) |
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| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) |
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| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| Fibrinogen | Vascular disorders | CTCAE (3.0) |
| ||
| Ptt | Vascular disorders | CTCAE (3.0) |
| ||
| Fever | General disorders | CTCAE (3.0) |
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| Weight Loss | General disorders | CTCAE (3.0) |
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| Rigors/Chills | General disorders | CTCAE (3.0) |
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| Fatigue | General disorders | CTCAE (3.0) |
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| Insomnia | General disorders | CTCAE (3.0) |
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| Hair Loss/Alopecia (Scalp Or Body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
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| Acne | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
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| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
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| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
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| Hot Flashes | Endocrine disorders | CTCAE (3.0) |
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| Heartburn | Gastrointestinal disorders | CTCAE (3.0) |
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| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) |
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| Taste Alteration | Gastrointestinal disorders | CTCAE (3.0) |
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| Mucositis (Functional/Sympt) - Oral Cavity | Gastrointestinal disorders | CTCAE (3.0) |
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| Mucositis (Clinical Exam) - Oral Cavity | Gastrointestinal disorders | CTCAE (3.0) |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) |
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| Anorexia | Gastrointestinal disorders | CTCAE (3.0) |
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| Dehydration | Gastrointestinal disorders | CTCAE (3.0) |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) |
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| Hemorrhage/Pulmonary - Nose | Vascular disorders | CTCAE (3.0) |
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| Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | Infections and infestations | CTCAE (3.0) |
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| Edema: Limb | Blood and lymphatic system disorders | CTCAE (3.0) |
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| Ast | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Cholesterol,serum High | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Alt | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Alkaline Phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Bilirubin | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Mood Alteration - Depression | Nervous system disorders | CTCAE (3.0) |
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| Mood Alteration - Anxiety | Nervous system disorders | CTCAE (3.0) |
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| Dizziness | Nervous system disorders | CTCAE (3.0) |
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| Neuropathy-Sensory | Nervous system disorders | CTCAE (3.0) |
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| Blurred Vision | Eye disorders | CTCAE (3.0) |
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| Pain - Other | General disorders | CTCAE (3.0) |
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| Pain: Chest /Thorax Nos | General disorders | CTCAE (3.0) |
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| Pain: Head/Headache | General disorders | CTCAE (3.0) |
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| Pain: Extremity-Limb | General disorders | CTCAE (3.0) |
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| Pain: Back | General disorders | CTCAE (3.0) |
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| Pain: Joint | General disorders | CTCAE (3.0) |
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| Pain: Abdominal Pain Nos | General disorders | CTCAE (3.0) |
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| Pain: Muscle | General disorders | CTCAE (3.0) |
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| Nasal/Paranasal Reactions | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
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| Urinary Frequency | Renal and urinary disorders | CTCAE (3.0) |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Leventhal | Gynecologic Oncology Group Statistical and Data Center | 716-845-4030 | mleventhal@gogstats.org |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C401859 | temsirolimus |
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| 50-59 years |
|
| 60-69 years |
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| 70-79 years |
|
| 80-89 years |
|
| Endometrioid Adenocarcinoma |
|
| Serous Adenocarcinoma |
|
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Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
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| Disease Progression |
|
| Refused Further Treatment |
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| Toxicity as permitted |
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| Other |
|
| Unspecified |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Alive without disease progression |
| |||||
| Alive with disease progression |
| |||||
| Dead from disease |
| |||||
| Dead from neither treatment nor disease |
|