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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-0076GG | |||
| CDR0000597154 | Other Identifier | CDR | |
| NCI-2009-00572 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 pemetrexed together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving pemetrexed together with cisplatin and to see how well it works in treating patients with advanced, persistent, or recurrent cervical cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prior cisplatin therapy as a radiosensitizer (yes vs no).
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1-4 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed and cisplatin | Experimental | Pemtrexed plus cisplatin on day 1 every 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | 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. | CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression or study withdrawal; and at any other time if clinically indicated, up to 5 years. |
| Frequency and Severity of Observed Adverse Effects | All eligible and evaluable patients | every 21 days during study treatment and up to 30 days after the last cycle of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Duration of progression-free survival in months. | From enrollment onto the study until the onset of disease progression or death, up to 5 years |
| Duration of Overall Survival |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed squamous or nonsquamous cell carcinoma of the cervix
Disease not amenable to curative therapy
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
Must have ≥ 1 target lesion to be used to assess response
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Recovered from effects of recent surgery, radiotherapy, or other therapy
At least 1 week since prior hormonal therapy directed at the malignant tumor
At least 4 weeks since prior radiotherapy
More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin and patient remains free of recurrent or metastatic disease
No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of cervical cancer
No prior radiotherapy to more than 25% of marrow-bearing areas
No prior cancer treatment that contraindicates study treatment
No prior cytotoxic drugs for advanced or recurrent carcinoma of the cervix
No nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates 2-5 days before, during, or for 2 days after receiving pemetrexed disodium
Concurrent hormone replacement therapy is permitted
Concurrent daily low-dose acetylsalicylic acid therapy (≤ 325 mg/day) allowed
Concurrent use of acetylsalicylic acid (up to 1.3 g/day) allowed
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| Name | Affiliation | Role |
|---|---|---|
| David S. Miller, MD | Simmons Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90089-9181 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed and Cisplatin | Pemtrexed plus cisplatin on day 1 every 21 days cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of pemetrexed disodium |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| pemetrexed disodium | Drug |
|
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
| Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually, up to 5 years. |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center |
| Orange |
| California |
| 92868 |
| United States |
| University of Mississippi Cancer Clinic | Jackson | Mississippi | 39216 | United States |
| Women's Cancer Center - La Canada | Las Vegas | Nevada | 89169 | United States |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Cancer Care Associates - Saint Francis Campus | Tulsa | Oklahoma | 74136-1929 | United States |
| Parkland Memorial Hospital | Dallas | Texas | 75235 | United States |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
| Lyndon B. Johnson General Hospital | Houston | Texas | 77026-1967 | United States |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| Carilion Gynecologic Oncology Associates | Roanoke | Virginia | 24016 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed and Cisplatin | Pemtrexed plus cisplatin on day 1 every 21 days cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of pemetrexed disodium |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Race (NIH/OMB) | 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 | Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | 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. | Individuals who initiated study treatment | Posted | Number | participants | CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression or study withdrawal; and at any other time if clinically indicated, up to 5 years. |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Frequency and Severity of Observed Adverse Effects | All eligible and evaluable patients | All eligible and evaluable patients. | Posted | Count of Participants | Participants | every 21 days during study treatment and up to 30 days after the last cycle of treatment. |
| |||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Duration of progression-free survival in months. | Individuals who initiated study treatment | Posted | Median | Inter-Quartile Range | months | From enrollment onto the study until the onset of disease progression or death, up to 5 years |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Overall Survival | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. | Eligible and treated patients | Posted | Median | Full Range | months | Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually, up to 5 years. |
|
|
All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
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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 | Pemetrexed and Cisplatin | Pemtrexed plus cisplatin on day 1 every 21 days cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of pemetrexed disodium | 23 | 54 | 54 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction/Hypersensitivity | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Death No Ctcae Term - Sudden Death | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fistula, Gi - Colon/Cecum/Appendix | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Perforation, Gi - Appendix | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Perforation, Gi - Colon | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gu - Vagina | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gi - Stomach | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Febrile Neutropenia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Skin (Cellulitis) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Kidney | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Chest Wall | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Head/Headache | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Back | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Abdominal Pain Nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Stricture, Anastomotic, Gu - Ureter | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergy/Immunology - Other | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Allergic Reaction/Hypersensitivity | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rhinitis | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Auditory/Ear - Other | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hearing (Without Monitoring Program) | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hearing (Monitoring Program) | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood/Bone Marrow - Other | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| S/N Arrhythmia: Atrial Fibrillation | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| S/N Arrhythmia: Sinus Tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| S/N Arrhythmia: Sinus Bradycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inr | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ptt | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constitutional Symptoms - Other | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sweating | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight Gain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight Loss | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Obesity | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rigors/Chills | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nail Changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Injection Site Reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hair Loss/Alopecia (Scalp Or Body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Erythema Multiforme | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bruising | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Decubitus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatology/Skin - Other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hot Flashes | Endocrine disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fistula, Gi - Small Bowel Nos | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dental: Teeth | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Taste Alteration | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis (Functional/Sympt) - Oral Cavity | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Obstruction, Gi - Small Bowel Nos | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Necrosis, Gi - Stoma | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis (Functional/Sympt) - Anus | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis (Clinical Exam) - Oral Cavity | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis (Clinical Exam) - Esophagus | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal - Other | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gu - Urinary Nos | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gu - Vagina | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gi - Rectum | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage/Pulmonary - Nose | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gi - Anus | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gu - Uterus | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gi - Oral Cavity | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gu - Kidney | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gi - Stomach | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gi - Abdomen Nos | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Salivary Gland | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection - Other | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Vagina | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Sinus | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc:peritoneal Cavity | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Urinary Tract Nos | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf Unknown Anc: Salivary Gland | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Kidney | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema: Trunk/Genital | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema: Limb | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema: Head And Neck | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ast | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Metabolic/Laboratory - Other | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proteinuria | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alt | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alkaline Phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bilirubin | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bicarbonate, Serum-Low | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Musculoskeletal/St: Other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscle Weakness - Whole Body/Generalized | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscle Weakness - Extremity-Upper | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neurology - Other | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mood Alteration - Depression | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mood Alteration - Anxiety | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mood Alteration - Agitation | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cognitive Disturbance | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neuropathy-Sensory | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neuropathy-Motor | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ocular/Visual - Other | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Watery Eye | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry Eye | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Flashing Lights/Floaters | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blurred Vision | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Other | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Urethra | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Pelvis | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Chest /Thorax Nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Chest Wall | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Throat/Pharynx/Larynx | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Head/Headache | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Neck | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Extremity-Limb | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Buttock | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Back | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Joint | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Bone | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Lymph Node | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Kidney | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Bladder | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Pain Nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Stomach | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Rectum | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Abdominal Pain Nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Oral - Gums | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Middle Ear | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: External Ear | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Cardiac/ Heart | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Muscle | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Anus | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dlco | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal/Genitourinary - Other | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Stricture, Anastomotic, Gu - Ureter | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Obstruction, Gu - Ureter | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Incontinence, Urinary | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fistula, Gu - Vagina | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bladder Spasm | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary Frequency | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vaginal Discharge | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Syndromes - Other | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cytokine Release Syndrome | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis/Embolism (Vascular Access-Related) | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis/Thrombus/Embolism | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Gedeon for Mark Brady, PhD | Gynecologic Oncology Group | 716-845-1169 | lgedeon@gogstats.org |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 50-59 years |
|
| >60 years |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0 |
| OG005 | Grade 5 (CTCAE v 3.0) | Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0 |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|