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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02400 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000068839 | |||
| GOG-0170D | Other Identifier | Gynecologic Oncology Group | |
| GOG-0170D | 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 to see if bevacizumab works in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.
PRIMARY OBJECTIVES:
I. Determine the 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab.
II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the progression-free and overall survival of patients treated with this drug.
IV. Determine the frequency of clinical response in patients treated with this drug.
V. Determine the effect of this drug on initial performance status, age, and mucinous or clear cell histology in these patients.
VI. Correlate biological and imaging markers with 6-month progression-free survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (bevacizumab) | Experimental | Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival at 6 Months | 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. | Every other cycle for 6 months. |
| Tumor Response | 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. | Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months thereafter for up to 5 years. |
| Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC. | Assessed every cycle while on treatment, 30 days after the last cycle of treatment, up to 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The observed length of life from entry into the study to death or the date of last contact. | From study entry to death or last contact, up to 5 years. |
| Duration of Progression-free Survival |
Not provided
Inclusion Criteria:
Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
At least 1 unidimensionally measurable target lesion
Accessible to guided core needle biopsy
Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or another organoplatinum compound) for primary disease
No tumors involving major blood vessels
No evidence of CNS disease (primary brain tumor or brain metastases) within the past 5 years
Ineligible for higher priority Gynecologic Oncology Group (GOG) protocols (i.e., active phase III GOG protocols for the same patient population)
Performance status - GOG 0-2 (patients who have received 1 prior regimen)
Performance status - GOG 0-1 (patients who have received 2 prior regimens)
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
No known bleeding disorder or coagulopathy
No active bleeding
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
serum glutamate oxaloacetate transaminase (SGOT) ≤ 2.5 times ULN
Alkaline phosphatase ≤ 2.5 times ULN
PT (INR) ≤ 1.5 (INR 2-3 if on stable dose of therapeutic warfarin or low molecular weight heparin)
Partial thromboplastin time (PTT) < 1.2 times control
Creatinine ≤ 1.5 times ULN
Creatinine clearance > 60 mL/min
No proteinuria, as indicated by 1 of the following:
No clinically significant cardiovascular disease, including any of the following:
No stroke within the past 5 years
No pathologic condition that carries a high risk of bleeding
No significant traumatic injury within the past 28 days
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
No uncontrolled seizures within the past 5 years
No neuropathy (motor and sensory) ≥ grade 2
No serious non-healing wound, ulcer, or bone fracture
No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
No active infection requiring parenteral antibiotics
No known claustrophobia that would preclude MRI tolerance
No ferromagnetic implants or pacers
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 3 months after study treatment
At least 3 weeks since prior immunologic therapy directed at malignancy
No prior bevacizumab
No other concurrent immunotherapy directed at malignancy
One additional prior cytotoxic regimen for recurrent or persistent disease allowed
No prior non-cytotoxic chemotherapy for recurrent or persistent disease
No concurrent chemotherapy directed at malignancy
At least 1 week since prior hormonal therapy directed at malignancy
No concurrent hormonal therapy directed at malignancy
Concurrent hormone replacement therapy allowed
Recovered from prior radiotherapy
No concurrent radiotherapy directed at malignancy
At least 28 days since prior major surgery or open biopsy and recovered
At least 7 days since prior core biopsy or placement of vascular access device
No anticipated need for major surgical procedure during study participation
At least 3 weeks since other prior therapy directed at malignancy
No prior anticancer therapy that would preclude study entry
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| Name | Affiliation | Role |
|---|---|---|
| Robert Burger | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
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The study was activated on 4/29/2002 and closed to accrual on 8/25/2004 (suspended from 10/6/2003 to 12/1/2003).
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab | Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| laboratory biomarker analysis | Other | Correlative studies |
|
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.
| Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months therafter for up to 5 years. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Eligible and treated patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab | Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy |
| 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 |
| |||||||||||||||||||||||
| Histologic Type | 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 | Progression-free Survival at 6 Months | 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 treated patients. | Posted | Number | 90% Confidence Interval | percentage of participants | Every other cycle for 6 months. |
|
|
| |||||||||||||||||||||||||
| Primary | Tumor Response | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months thereafter for up to 5 years. |
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC. | Eligible and evaluable patients | Posted | Count of Participants | Participants | Assessed every cycle while on treatment, 30 days after the last cycle of treatment, up to 5 years. |
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival | The observed length of life from entry into the study to 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. |
|
| ||||||||||||||||||||||||||
| 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 treated patients | Posted | Median | Inter-Quartile Range | months | Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months therafter for up to 5 years. |
|
|
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) 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 | Bevacizumab | Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy | 26 | 62 | 62 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hematologic Other | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Edema | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Thrombosis Embolism | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ischemia/Cardiac Infarction | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Partial Thromboplastin Time | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Weight Gain(No Vod) | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Vomitting | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Gi Other | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Melena/Gi Bleeding | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Abdominal Pain | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pain Tumor | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Voice Changes/Stridor/Larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Rhinitis | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Allergic Reaction | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Inner Ear/Hearing | Ear and labyrinth disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Middle Ear/Hearing | Ear and labyrinth disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Transfusion Prbc's | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hematologic Other | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Conduction Abnorm Atrioventricular Block | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Arrhythmia Super Ventricular | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Phlebitis Superficial | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Sinus Bradycardia | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Edema | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Thrombosis Embolism | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ischemia/Cardiac Infarction | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Prothrombin Time | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Coagulation Other | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Partial Thromboplastin Time | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fever(No Neutropenia) | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Weight Loss | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rigors Chills | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Weight Gain(No Vod) | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Sweating | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rash Desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Skin Other | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Nail Changes | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pigmentation Changes | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Photosensitivity | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hand-Foot Skin Reaction | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Bruising | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hot Flashes/Flushes | Endocrine disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Diarrhea With Colostomy | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Mouth Dryness | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ascites Non-Malignant | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dyspepsia/Heartburn | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Taste Disturbance | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dysphagia Esophagitis Odynophagia | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Diarrhea Without Colostomy | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Stomatitis/Pharyngitis | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Vomitting | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Gi Other | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemorrhage Other | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rectal Bleeding/Hematochezia | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Epistaxis | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Melena/Gi Bleeding | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemorrhage Without Grade 3/4 Thrombocytopenia | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Vaginal Bleeding | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hematuria No Vaginal Bleeding | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ggt(Gamma-Glutamyltranspeptidase) | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hepatic Other | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Sgot(Alt) | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Sgot(Ast) | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Alkaline Phosphatase | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Bilirubin | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection Without Neutropenia | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Lymphatics Other | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Lymphatics | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypercholesterolemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Metabolic Other | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypertyiglyceridemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Bicarbonate | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypomagnesmia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Musculoskeletal Other | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Extrapyramidal | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Depressed Level Of Consciousness | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Vertigo | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Mood Alteration Anxeity/Agitation | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Memory Loss | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Insomnia | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Mood Alteration Depression | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Neuropathy Sensor | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pyramidal Tract Dysfunction | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ocular Other | Eye disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Tearing | Eye disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dry Eye | Eye disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Vision Blurres | Eye disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Abdominal Pain | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pain Other | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pain Tumor | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pleuritic Pain | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Neuropathic Pain | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Earache | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dyspareunia | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Headache | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pelvic Pain | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Chest Pain | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Bone Pain | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Arthralgia | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Myalgia | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pain Rectal/Perirectal | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Voice Changes/Stridor/Larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pulmonary Other | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ards | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pneumonitis/Pulmonary Infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Urinary Frequency/Urgency | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Creatinine | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Renal/Gu Other | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Vaginitis No Infection | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ureteral Obstruction | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemoglobinuria | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Bladder Spasms | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Vaginal Dryness | Reproductive system and breast disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Libido | Reproductive system and breast disorders | CTCAE (2.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela M. Kuras, Associate Director of Data Management | NRG Oncology Statistics and Data Management Center - Buffalo | 716-845-7733 | kurasa@nrgoncology.org |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| 30-39 years |
|
| 40-49 years |
|
| 50-59 years |
|
| 60-69 years |
|
| 70-79 years |
|
| Endometrioid Adenocarcinoma |
|
| Mixed Epithelial Carcinoma |
|
| Serous Adenocarcinoma |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|