Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BMS-CA225-075 | |||
| CDR0000405839 |
Not provided
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Bristol-Myers Squibb | INDUSTRY |
Not provided
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RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also help cisplatin work better by making tumor cells more sensitive to the drug. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with cisplatin may be a better way to block tumor growth.
PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin works in treating patients with advanced, persistent, or recurrent cervical cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and cisplatin IV on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within 9-20 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetuximab | Biological | |||
| cisplatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | Per GOG Response Evaluation Criteria In Solid Tumors(RECIST) Criteria: Complete Response(CR): disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response(PR): 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 nontarget lesions and no new lesions. Increasing Disease: 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 within 8 weeks of study entry. Stable Disease: any condition not meeting the above criteria. Indeterminate for response: as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease. | up to 6 months from study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment | up to 5 years from study entry |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed squamous or non-squamous cell carcinoma of the cervix
Not amenable to curative therapy
Measurable disease
At least 1 target lesion
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No significant history of cardiac disease within the past 6 months, including the following:
Neurologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Not provided
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Not provided
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| Name | Affiliation | Role |
|---|---|---|
| John H. Farley, MD | Uniformed Services University of the Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Saint Joseph Medical Center - Burbank | Burbank | California | 91505 | United States | ||
| USC/Norris Comprehensive Cancer Center and Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21329967 | Result | Farley J, Sill MW, Birrer M, Walker J, Schilder RJ, Thigpen JT, Coleman RL, Miller BE, Rose PG, Lankes HA. Phase II study of cisplatin plus cetuximab in advanced, recurrent, and previously treated cancers of the cervix and evaluation of epidermal growth factor receptor immunohistochemical expression: a Gynecologic Oncology Group study. Gynecol Oncol. 2011 May 1;121(2):303-8. doi: 10.1016/j.ygyno.2011.01.030. Epub 2011 Feb 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cetuximab | Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Los Angeles |
| California |
| 90089-9181 |
| United States |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | 31403-3089 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | United States |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Christus Schumpert Cancer Treatment Center | Shreveport | Louisiana | 71101 | United States |
| University of Mississippi Cancer Clinic | Jackson | Mississippi | 39216 | United States |
| Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees Township | New Jersey | 08043 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Cancer Care Associates - Midtown Tulsa | Tulsa | Oklahoma | 74104 | United States |
| Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | 19111-2497 | United States |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading | Pennsylvania | 19612-6052 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0361 | United States |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Eligible and evaluable participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cetuximab | Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) 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 |
| |||||||||||||||||||||||
| Cell 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 | Tumor Response | Per GOG Response Evaluation Criteria In Solid Tumors(RECIST) Criteria: Complete Response(CR): disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response(PR): 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 nontarget lesions and no new lesions. Increasing Disease: 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 within 8 weeks of study entry. Stable Disease: any condition not meeting the above criteria. Indeterminate for response: as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease. | Eligible and evaluable participants | Posted | Number | participants | up to 6 months from study entry |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment | Not Posted | up to 5 years from study entry |
from study entry 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) considered to be treatment related for up to 5 years after stopping study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cetuximab | Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy. | 33 | 69 | 66 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death No Ctcae Term - Disease Progression Nos | General disorders | CTCAE (3.0) |
| ||
| Fistula, Gi - Ileum | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Obstruction, Gi - Colon | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Obstruction, Gi - Small Bowel Nos | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Perforation, Gi - Small Bowel Nos | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Nausea | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Hemorrhage, Gu - Vagina | Vascular disorders | CTCAE (3.0) |
| ||
| Hemorrhage/Bleeding - Other | Vascular disorders | CTCAE (3.0) |
| ||
| Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | Infections and infestations | CTCAE (3.0) |
| ||
| Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia | Infections and infestations | CTCAE (3.0) |
| ||
| Inf W/Nml Or Gr 1 Or 2 Anc: Kidney | Infections and infestations | CTCAE (3.0) |
| ||
| Inf W/Nml Or Gr 1 Or 2 Anc: Bladder | Infections and infestations | CTCAE (3.0) |
| ||
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Ggt | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Pain - Other | General disorders | CTCAE (3.0) |
| ||
| Pain: Extremity-Limb | General disorders | CTCAE (3.0) |
| ||
| Pain: Muscle | General disorders | CTCAE (3.0) |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Obstruction, Gu - Urethra | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Obstruction, Gu - Ureter | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Fistula, Gu - Vagina | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Renal Failure | 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 |
|---|---|---|---|---|---|
| Allergic Reaction/Hypersensitivity | Immune system disorders | CTCAE (3.0) |
| ||
| Otitis Middle Ear | Ear and labyrinth disorders | CTCAE (3.0) |
| ||
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) |
| ||
| Hearing (Monitoring Program) | Ear and labyrinth disorders | CTCAE (3.0) |
| ||
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| Hemolysis | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| S/N Arrhythmia: Atrial Fibrillation | Cardiac disorders | CTCAE (3.0) |
| ||
| Palpitations | Cardiac disorders | CTCAE (3.0) |
| ||
| S/N Arrhythmia: Sinus Tachycardia | Cardiac disorders | CTCAE (3.0) |
| ||
| S/N Arrhythmia: Atrial Tachycardia | Cardiac disorders | CTCAE (3.0) |
| ||
| Hypertension | Cardiac disorders | CTCAE (3.0) |
| ||
| Hypotension | Cardiac disorders | CTCAE (3.0) |
| ||
| Cardipulmonary Arrest | Cardiac disorders | CTCAE (3.0) |
| ||
| Inr | Vascular disorders | CTCAE (3.0) |
| ||
| Fibrinogen | Vascular disorders | CTCAE (3.0) |
| ||
| Ptt | Vascular disorders | CTCAE (3.0) |
| ||
| Sweating | General disorders | CTCAE (3.0) |
| ||
| Fever | General disorders | CTCAE (3.0) |
| ||
| Weight Loss | General disorders | CTCAE (3.0) |
| ||
| Rigors/Chills | General disorders | CTCAE (3.0) |
| ||
| Fatigue | General disorders | CTCAE (3.0) |
| ||
| Insomnia | General disorders | CTCAE (3.0) |
| ||
| Nail Changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Hair Loss/Alopecia (Scalp Or Body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Wound Complication, Non-Infectious | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Acne | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Decubitus | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Burn | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Flushing | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Hand-Foot | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Hot Flashes | Endocrine disorders | CTCAE (3.0) |
| ||
| Masculinization Of Female | Endocrine disorders | CTCAE (3.0) |
| ||
| Fistula, Gi - Rectum | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Gastritis | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Heartburn | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Dental: Teeth | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Ileus | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Distention | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Taste Alteration | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Dry Mouth | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Mucositis (Functional/Sympt) - Oral Cavity | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Stricture, Gi - Colon | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Obstruction, Gi - Small Bowel Nos | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Mucositis (Clinical Exam) - Oral Cavity | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Constipation | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Nausea | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Gastrointestinal - Other | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Hemorrhage, Gu - Urinary Nos | Vascular disorders | CTCAE (3.0) |
| ||
| Hemorrhage, Gu - Vagina | Vascular disorders | CTCAE (3.0) |
| ||
| Hemorrhage, Gi - Rectum | Vascular disorders | CTCAE (3.0) |
| ||
| Hemorrhage, Gu - Ovary | Vascular disorders | CTCAE (3.0) |
| ||
| Hemorrhage/Pulmonary - Nose | Vascular disorders | CTCAE (3.0) |
| ||
| Hemorrhage, Gi - Oral Cavity | Vascular disorders | CTCAE (3.0) |
| ||
| Hemorrhage, Gu - Bladder | Vascular disorders | CTCAE (3.0) |
| ||
| Hemorrhage, Gi - Abdomen Nos | Vascular disorders | CTCAE (3.0) |
| ||
| Petechiae | Vascular disorders | CTCAE (3.0) |
| ||
| Inf W/Nml Or Gr 1 Or 2 Anc: Uterus | Infections and infestations | CTCAE (3.0) |
| ||
| Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) | Infections and infestations | CTCAE (3.0) |
| ||
| Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) | Infections and infestations | CTCAE (3.0) |
| ||
| Inf Unknown Anc: Lung (Pneumonia) | Infections and infestations | CTCAE (3.0) |
| ||
| Inf Unknown Anc: Nose | Infections and infestations | CTCAE (3.0) |
| ||
| Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | Infections and infestations | CTCAE (3.0) |
| ||
| Infection - Other | Infections and infestations | CTCAE (3.0) |
| ||
| Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus | Infections and infestations | CTCAE (3.0) |
| ||
| Inf W/Nml Or Gr 1 Or 2 Anc: Vagina | Infections and infestations | CTCAE (3.0) |
| ||
| Inf W/Nml Or Gr 1 Or 2 Anc: Sinus | Infections and infestations | CTCAE (3.0) |
| ||
| Inf Unknown Anc: Urinary Tract Nos | Infections and infestations | CTCAE (3.0) |
| ||
| Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia) | Infections and infestations | CTCAE (3.0) |
| ||
| Inf W/Nml Or Gr 1 Or 2 Anc: Bladder | Infections and infestations | CTCAE (3.0) |
| ||
| Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos | Infections and infestations | CTCAE (3.0) |
| ||
| Edema: Limb | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| Ast | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Metabolic/Laboratory - Other | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Cholesterol,serum High | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Proteinuria | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Ggt | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Alt | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Alkaline Phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Bilirubin | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Cpk | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Bicarbonate, Serum-Low | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Amylase | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) |
| ||
| Myositis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| Extremity-Upper (Function) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| Gait/Walking | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| Muscle Weakness - Whole Body/Generalized | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| Muscle Weakness - Left-Sided | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| Muscle Weakness - Extremity-Lower | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
| ||
| Pyramidal Tract Dysfunction | Nervous system disorders | CTCAE (3.0) |
| ||
| Mood Alteration - Depression | Nervous system disorders | CTCAE (3.0) |
| ||
| Mood Alteration - Anxiety | Nervous system disorders | CTCAE (3.0) |
| ||
| Tremor | Nervous system disorders | CTCAE (3.0) |
| ||
| Confusion | Nervous system disorders | CTCAE (3.0) |
| ||
| Dizziness | Nervous system disorders | CTCAE (3.0) |
| ||
| Neuropathy,cranial - Cn Xii Motor-Tongue | Nervous system disorders | CTCAE (3.0) |
| ||
| Neuropathy,cranial - Cn Ix Motor-Pharynx | Nervous system disorders | CTCAE (3.0) |
| ||
| Neuropathy-Sensory | Nervous system disorders | CTCAE (3.0) |
| ||
| Neuropathy-Motor | Nervous system disorders | CTCAE (3.0) |
| ||
| Dry Eye | Eye disorders | CTCAE (3.0) |
| ||
| Flashing Lights/Floaters | Eye disorders | CTCAE (3.0) |
| ||
| Blurred Vision | Eye disorders | CTCAE (3.0) |
| ||
| Pain - Other | General disorders | CTCAE (3.0) |
| ||
| Pain: Pelvis | General disorders | CTCAE (3.0) |
| ||
| Pain: Breast | General disorders | CTCAE (3.0) |
| ||
| Pain: Vagina | General disorders | CTCAE (3.0) |
| ||
| Pain: Chest /Thorax Nos | General disorders | CTCAE (3.0) |
| ||
| Pain: Chest Wall | General disorders | CTCAE (3.0) |
| ||
| Pain: Throat/Pharynx/Larynx | General disorders | CTCAE (3.0) |
| ||
| Pain: Head/Headache | General disorders | CTCAE (3.0) |
| ||
| Pain: Neck | General disorders | CTCAE (3.0) |
| ||
| Pain: Extremity-Limb | General disorders | CTCAE (3.0) |
| ||
| Pain: Buttock | General disorders | CTCAE (3.0) |
| ||
| Pain: Back | General disorders | CTCAE (3.0) |
| ||
| Pain: Joint | General disorders | CTCAE (3.0) |
| ||
| Pain: Bone | General disorders | CTCAE (3.0) |
| ||
| Pain: Kidney | General disorders | CTCAE (3.0) |
| ||
| Pain: Bladder | General disorders | CTCAE (3.0) |
| ||
| Pain: Stomach | General disorders | CTCAE (3.0) |
| ||
| Pain: Rectum | General disorders | CTCAE (3.0) |
| ||
| Pain: Oral Cavity | General disorders | CTCAE (3.0) |
| ||
| Pain: Esophagus | General disorders | CTCAE (3.0) |
| ||
| Pain: Dental/Teeth/Peridontal | General disorders | CTCAE (3.0) |
| ||
| Pain: Abdominal Pain Nos | General disorders | CTCAE (3.0) |
| ||
| Pain: Skin | General disorders | CTCAE (3.0) |
| ||
| Pain: Tumor | General disorders | CTCAE (3.0) |
| ||
| Pain: Muscle | General disorders | CTCAE (3.0) |
| ||
| Pain: Neuralgia | General disorders | CTCAE (3.0) |
| ||
| Pulmonary: Other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Airway Obstruction - Bronchus | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Nasal/Paranasal Reactions | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Voice Changes | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Renal/Genitourinary - Other | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Leak, Gu - Vagina | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Cystitis | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Urinary Retention | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Obstruction, Gu - Ureter | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Incontinence, Urinary | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Fistula, Gu - Vagina | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Fistula, Gu - Bladder | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Bladder Spasm | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Renal Failure | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Urinary Frequency | Renal and urinary disorders | CTCAE (3.0) |
| ||
| Vaginal Discharge | Reproductive system and breast disorders | CTCAE (3.0) |
| ||
| Flu-Like Syndrome | General disorders | CTCAE (3.0) |
| ||
| Thrombosis/Thrombus/Embolism | Vascular disorders | CTCAE (3.0) |
| ||
| Phlebitis | Vascular disorders | CTCAE (3.0) |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Leventhal | Gynecologic Oncology Group Statistical and Data Center | 716-341-3408 | mleventhal@gogstats.org |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D002945 | Cisplatin |
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| 40-49 years |
|
| 50-59 years |
|
| 60-69 years |
|
| 70-79 years |
|
| Mucinous Adenocarcinoma |
|
| Adenosquamous |
|
| Squamous Cell Carcinoma |
|
| Title | Measurements |
|---|---|
|
| Stable Disease |
|
| Indeterminate |
|