Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000517318 | |||
| LILLY-H6Q-MC-S025 |
Not provided
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well enzastaurin works in treating patients with persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral enzastaurin hydrochloride 3 times on day 1 and then once daily on days 2-28 of course 1. For all subsequent courses, patients receive enzastaurin hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzastaurin hydrochloride | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of 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. | CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years. |
| Progression-free Survival > 6 Months Using RECIST 1.0 | Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. | CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years. |
| Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Number of participants with a maximum grade of 3 or higher during the treatment period. | Assessed every cycle while on treatment, 30 days after the last cycle of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Duration Overall Survival | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. | Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years. |
| Duration of Progression-free Survival (PFS) |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
Recurrent or persistent disease
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 assess response
Must have received 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
Initial treatment may have included high-dose therapy, consolidation therapy, or extended therapy administered after surgical or nonsurgical assessment
Must meet any 1 of the following criteria for platinum-based therapy:
Ineligible for a higher priority GOG clinical trial
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Lydia Usha, MD | Rush University Medical Center | Study Chair |
| Jean A. Hurteau, MD | Endeavor Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States | ||
| Rush University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21414654 | Result | Usha L, Sill MW, Darcy KM, Benbrook DM, Hurteau JA, Michelin DP, Mannel RS, Hanjani P, De Geest K, Godwin AK. A Gynecologic Oncology Group phase II trial of the protein kinase C-beta inhibitor, enzastaurin and evaluation of markers with potential predictive and prognostic value in persistent or recurrent epithelial ovarian and primary peritoneal malignancies. Gynecol Oncol. 2011 Jun 1;121(3):455-61. doi: 10.1016/j.ygyno.2011.02.013. Epub 2011 Mar 17. |
Not provided
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This trial was opened to patient entry on November 6, 2006 and was closed to accrual on May 7, 2007.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enzastaurin | Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. |
| CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years. |
| Prognostic Factor - Number of Patients With Platinum Sensitivity | Platinum sensitive = a platinum-free interval between 6 and 12 months. | Baseline |
| Prognostic Factor - Initial Performance Status | Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work | Baseline |
| Prognostic Factor - Age at Study Entry | Baseline |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois | 62526 | United States |
| Evanston Northwestern Healthcare - Evanston Hospital | Evanston | Illinois | 60201-1781 | United States |
| Hinsdale Hematology Oncology Associates | Hinsdale | Illinois | 60521 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| St. Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| Methodist Estabrook Cancer Center | Omaha | Nebraska | 68114 | United States |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | United States |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Abington | Pennsylvania | 19001 | 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 Cancer Center at University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| COMPLETED | Eligible and treated patients. |
|
| NOT COMPLETED |
|
|
Eligible and treated patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enzastaurin | Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Number of 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. | Eligible and treated patients | Posted | Count of Participants | Participants | No | CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years. |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Progression-free Survival > 6 Months Using RECIST 1.0 | Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. | Eligible and treated patients | Posted | Count of Participants | Participants | No | CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years. |
|
| |||||||||||||||||||||||||||||||||
| Primary | Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Number of participants with a maximum grade of 3 or higher during the treatment period. | Eligible and treated patients | Posted | Count of Participants | Participants | No | Assessed every cycle while on treatment, 30 days after the last cycle of treatment |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Duration 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 | 90% Confidence Interval | months | Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years. |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Progression-free Survival (PFS) | Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. | Eligible and treated patients | Posted | Median | 90% Confidence Interval | months | CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years. |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Prognostic Factor - Number of Patients With Platinum Sensitivity | Platinum sensitive = a platinum-free interval between 6 and 12 months. | Eligible and treated patients | Posted | Count of Participants | Participants | No | Baseline |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Prognostic Factor - Initial Performance Status | Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work | Eligible and treated patients | Posted | Count of Participants | Participants | No | Baseline |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Prognostic Factor - Age at Study Entry | Eligible and treated patients | Posted | Median | Inter-Quartile Range | years | Baseline |
|
|
Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Not provided
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 | Enzastaurin | Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days. | 12 | 27 | 27 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death No Ctcae Term - Disease Progression Nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Obstruction, Gi - Rectum | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Obstruction, Gi - Colon | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ascites | 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 |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Abdominal Pain Nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis/Thrombus/Embolism | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinitis | Immune system 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 |
| |
| 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 |
| |
| Palpitations | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension | Cardiac 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 |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hair Loss/Alopecia (Scalp Or Body) | 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 |
| |
| Ulceration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hot Flashes | Endocrine disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diabetes | Endocrine disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Obstruction, Gi - Colon | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Distention | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Taste Alteration | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Incontinence, Anal | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Obstruction, Gi - Small Bowel Nos | 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 - Vagina | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gi - Rectum | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gi - Upper Gi Nos | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage/Pulmonary - Nose | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Petechiae | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Pleura | 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: Wound | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) | 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: Colon | 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 W/Nml Or Gr 1 Or 2 Anc: Vagina | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Inf W/Gr 3 Or 4 Anc: Vulva | Infections and infestations | 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 |
| |
| Gfr | 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 |
| |
| 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 |
| |
| 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 |
| |
| Hypomagnesemia | Metabolism and nutrition 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 |
| |
| Tremor | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Somnolence | 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 |
| |
| Pain: Pelvis | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Breast | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Chest /Thorax Nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Head/Headache | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Extremity-Limb | 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: Rectum | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Abdominal Pain Nos | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Tumor | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain: Muscle | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pulmonary: Other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cough | 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 |
| |
| Urinary Color Change | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vaginal Dryness | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Flu-Like Syndrome | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Kuras on behalf of Mike Sill, PhD | NRG Oncology | 716-845-5702 | kurasa@nrgoncology.org |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| 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 |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| 70-79 years |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|