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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02562 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NCI-5789 | |||
| CHNMC-PHII-45 | |||
| CDR0000340522 | |||
| CCC-PHII-45 | |||
| PHII-45 | Other Identifier | City of Hope Comprehensive Cancer Center | |
| 5789 | Other Identifier | CTEP | |
| N01CM17101 | U.S. NIH Grant/Contract | View source | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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This phase II trial is to see if combining bevacizumab with low-dose cyclophosphamide works in treating patients with ovarian epithelial or primary peritoneal cancer that has come back or spread to other parts of the body. 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. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with cyclophosphamide may kill more tumor cells.
OBJECTIVES: Primary I. Determine the time to progression in patients with recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab and low-dose cyclophosphamide.
Secondary I. Determine the response rate in patients treated with this regimen. II. Determine the toxicity of this regimen in these patients. III. Determine molecular correlates for response and outcomes in patients treated with this regimen.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study within 1-2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (bevacizumab, cyclophosphamide) | Experimental | Patients receive bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide on days 1-28. Courses repeat every 28 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 |
|---|---|---|
| Median Time to Progression | Time from treatment initiation to disease progresion calculated using the method of Kaplan-Meier. RECIST v1.0 was used to evaluate response. Progression was defined as a 20% or greater increase in the sums of the longest dimensions of target lesions, or the appearance of new lesions within 8 weeks of study entry. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate Based on the RECIST | Percentage of patients with a confirmed partial or complete response using RECIST v1.0 criteria. Complete response was defined as the disapperance of all target and nontarget lesions, no evidence of new lesions and normalization of CA-125; Partial response was defined as a 30% or greater reduction in the sum of the longest dimensions of all target lesions and no unequivocal progression of nontarget lesions, lasting at least 4 weeks. |
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Inclusion Criteria:
Histologically confirmed recurrent or metastatic ovarian epithelial or primary peritoneal cancer
Unidimensionally measurable disease
Received a platinum-containing regimen for primary disease
No more than 2 prior chemotherapy regimens for recurrent disease
No history or clinical evidence of CNS disease, including primary brain tumor
No brain metastases
Performance status - SWOG 0-2
At least 3 months
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
No bleeding diathesis
No coagulopathy
Bilirubin no greater than 1.5 times normal
ALT or AST no greater than 3 times upper limit of normal
INR less than 1.5 (for patients receiving warfarin)
Creatinine no greater than 1.5 times normal
No proteinuria (less than 1+)
Proteinuria less than 500 mg/24-hour urine collection
No prior deep vein thrombosis
No prior stroke
No clinically significant cardiovascular disease
None of the following within the past year:
None of the following within the past 6 months:
No clinically significant peripheral artery disease
No active infection requiring parenteral antibiotics
No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
Not pregnant or nursing
Fertile patients must use effective contraception
No serious, non-healing wound, ulcer, or bone fracture
No significant traumatic injury within the past 28 days
No seizures not controlled with standard medical therapy
No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No other concurrent medical, psychological, or social condition that would preclude study participation
No prior antiangiogenesis agents
See Disease Characteristics
Recovered from prior chemotherapy
See Disease Characteristics
Recovered from prior radiotherapy
More than 28 days since prior major surgical procedure or open biopsy and recovered
At least 3 weeks since prior therapy directed at the malignancy
No recent or concurrent full-dose anticoagulants or thrombolytic agents
No concurrent chronic daily aspirin (greater than 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function
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| Name | Affiliation | Role |
|---|---|---|
| Agustin Garcia | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Bevacizumab, Cyclophosphamide) | Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV cyclophosphamide: Given PO |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cyclophosphamide | Drug | Given PO |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Up to 3 years |
| Median Overall Survival | Calculated using the method of Kaplan-Meier. | Time from first day of treatment to time of death due to any cause, assessed up to 3 years |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Bevacizumab, Cyclophosphamide) | Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV cyclophosphamide: Given PO |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | 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 | Median Time to Progression | Time from treatment initiation to disease progresion calculated using the method of Kaplan-Meier. RECIST v1.0 was used to evaluate response. Progression was defined as a 20% or greater increase in the sums of the longest dimensions of target lesions, or the appearance of new lesions within 8 weeks of study entry. | Posted | Median | 95% Confidence Interval | months | Up to 3 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Response Rate Based on the RECIST | Percentage of patients with a confirmed partial or complete response using RECIST v1.0 criteria. Complete response was defined as the disapperance of all target and nontarget lesions, no evidence of new lesions and normalization of CA-125; Partial response was defined as a 30% or greater reduction in the sum of the longest dimensions of all target lesions and no unequivocal progression of nontarget lesions, lasting at least 4 weeks. | Posted | Number | percentage of responding patients | Up to 3 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Median Overall Survival | Calculated using the method of Kaplan-Meier. | Posted | Median | 95% Confidence Interval | months | Time from first day of treatment to time of death due to any cause, assessed up to 3 years |
|
|
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"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to 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 (Bevacizumab, Cyclophosphamide) | Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV cyclophosphamide: Given PO | 23 | 70 | 70 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Cecal obstruction | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Jejunal perforation | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Death | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | meddra9.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Cardiac troponin T increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Myelodysplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra10.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ischemia cerebrovascular | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | meddra9.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood disorder | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Lymphatic disorder | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | meddra9.0 | Non-systematic Assessment |
| |
| External ear inflammation | Ear and labyrinth disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hearing loss | Ear and labyrinth disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hearing test abnormal | Ear and labyrinth disorders | meddra9.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | meddra9.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Flashing vision | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Colonic perforation | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Lip pain | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Malabsorption | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Oral hemorrhage | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Rectal fistula | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Chills | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Edema limbs | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Fever | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Flu-like symptoms | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| General symptom | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Localized edema | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pain | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Bladder infection | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Conjunctivitis infective | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Infectious colitis | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Lip infection | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Opportunistic infection | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Phlebitis infective | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Rhinitis infective | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Vulvitis | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | meddra9.0 | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | meddra9.0 | Non-systematic Assessment |
| |
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | meddra9.0 | Non-systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | meddra9.0 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | meddra9.0 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Coagulopathy | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Creatine phosphokinase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Haptoglobin decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Hyperbilirubinemia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Hypercholesterolemia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| INR increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Laboratory test abnormal | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Leukopenia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Serum cholesterol increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Weight gain | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Weight loss | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Glucose intolerance | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum magnesium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum triglycerides increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Joint disorder | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Tumor flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra9.0 | Non-systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra9.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ischemia cerebrovascular | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Olfactory nerve disorder | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sinus pain | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Taste alteration | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemoglobinuria | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemorrhage urinary tract | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Kidney pain | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Protein urine positive | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Urethral hemorrhage | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vaginal dryness | Reproductive system and breast disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vaginal inflammation | Reproductive system and breast disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vaginal pain | Reproductive system and breast disorders | meddra9.0 | Non-systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Bronchial fistula | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemorrhage nasal | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Laryngeal mucositis | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pharyngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Respiratory tract hemorrhage | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Photosensitivity | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemorrhage | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vascular disorder | Vascular disorders | meddra9.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DCC Project Administrator | California Cancer Consortium | 626-256-4673 | 60094 | CCCP@coh.org |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D007074 | Immunoglobulin G |
| D004220 | Disulfides |
| D003520 | Cyclophosphamide |
| 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 |
| D007132 | Immunoglobulin Isotypes |
| D013440 | Sulfides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006862 | Hydrogen Sulfide |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided
|
|