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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Celgene Corporation | INDUSTRY |
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The purpose of this study is to evaluate the effectiveness and tolerability of the combination of bevacizumab and Abraxane in the treatment of women with epithelial ovarian cancer or peritoneal cancer. The study will also evaluate how the patient's quality of life is during their treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab will be given via IV infusion at 10mg/kg given on days 1 and 15 of a 28-day cycle. |
| |
| Abraxane | Drug | Abraxane will be given via IV infusion at 100mg/m²over 30 minutes on days 1, 8, and 15 of a 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-month Progression-Free Rate | Progression-free rate is defined as the percentage of participants with no progression event at 6 months after starting study treatment. An event for this endpoint was defined as a progression-free survival event occurring earlier than six months, or discontinuation of treatment earlier than six months for any other reason. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. | 6 months after initiation of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response | Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee S. Schwartzberg, MD, FACP | The West Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock Hematology Oncology | Little Rock | Arkansas | 72205 | United States | ||
| Wilshire Oncology Medical Group, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22960352 | Derived | Tillmanns TD, Lowe MP, Walker MS, Stepanski EJ, Schwartzberg LS. Phase II clinical trial of bevacizumab with albumin-bound paclitaxel in patients with recurrent, platinum-resistant primary epithelial ovarian or primary peritoneal carcinoma. Gynecol Oncol. 2013 Feb;128(2):221-8. doi: 10.1016/j.ygyno.2012.08.039. Epub 2012 Sep 5. |
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Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.
9 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in January 2007 and was completed in December 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab and Abraxane | All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months. |
| Overall Survival | Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months. |
| Progression-free Survival (PFS) | Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. | PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first, assessed up to 30 months. |
| Best Overall Response at Six Months | The outcome measure assessed the percentage of participants who had achieved either a Partial or Complete Response over 6 months of treatment. Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR. | Assessed over 6 months of study treatment |
| La Verne |
| California |
| 91750 |
| United States |
| Northeast Georgia Cancer Care, LLC | Athens | Georgia | 30607 | United States |
| Southeastern Gynecologic Oncology, LLC | Atlanta | Georgia | 30342 | United States |
| North Idaho Cancer Center | Coeur d'Alene | Idaho | 38314 | United States |
| Hematology-Oncology Centers of the Northern Rockies | Billings | Montana | 59101 | United States |
| Mid-Ohio Oncology/Hematology | Columbus | Ohio | 43219 | United States |
| Pennsylvania Oncology Hematology Assoc. | Philadelphia | Pennsylvania | 19106 | United States |
| Chattanooga's Program in Women's Oncology | Chattanooga | Tennessee | 37403 | United States |
| The West Clinic | Memphis | Tennessee | 38120 | United States |
| Cancer Specialists of Tidewater, Ltd | Chesapeake | Virginia | 23320 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab and Abraxane | All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | 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 | 6-month Progression-Free Rate | Progression-free rate is defined as the percentage of participants with no progression event at 6 months after starting study treatment. An event for this endpoint was defined as a progression-free survival event occurring earlier than six months, or discontinuation of treatment earlier than six months for any other reason. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. | Posted | Number | 95% Confidence Interval | percentage of patients | 6 months after initiation of study treatment |
|
|
| ||||||||||||||||||||||||||
| Secondary | Best Overall Response | Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR. | Posted | Number | Participants | Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months. |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival | Participants who had not experienced death during or after stopping treatment were censored in the analysis. | Posted | Median | 95% Confidence Interval | Months | Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months. |
|
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. | Participants who had not experienced either disease progression or death during or after stopping treatment were censored in the analysis. | Posted | Median | 95% Confidence Interval | Months | PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first, assessed up to 30 months. |
|
| ||||||||||||||||||||||||||
| Secondary | Best Overall Response at Six Months | The outcome measure assessed the percentage of participants who had achieved either a Partial or Complete Response over 6 months of treatment. Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR. | The 2 tailed, 95% confidence interval of the estimated response rate was calculated using the normal approximation to the binomial distribution. | Posted | Number | 95% Confidence Interval | percentage of patients | Assessed over 6 months of study treatment |
|
|
Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 32 months.
Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab and Abraxane | All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle. | 13 | 48 | 47 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hernia obstructive | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Overdoses | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| External ear pain | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blepharitis | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diplopia | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Erythema of eyelid | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Eye hemorrhage | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Photopsia | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Feces hard | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Paresthesia oral | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Peritoneal and retroperitoneal disorders | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Reflux gastritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sore mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Asthenia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Catheter site inflammation | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chest pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Inflammation | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Local swelling | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Localized edema | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nodule | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema peripheral | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Multiple allergies | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Localized infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Postpoperative wound infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Vaginitis bacterial | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Post procedural hemorrhage | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Procedural site reaction | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Body temperature increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| CD4 lymphocytes increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Forced expiratory volume | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hematocrit decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Monoctye count increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Parasite stool test positive | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss poor | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Foot fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pituitary tumor benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoesthesia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Disturbance in attention | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema genital | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sexual dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vulvovaginal pruritis | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea exertional | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus disorder, NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nail discoloration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin discoloration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Umbilical hemorrhage | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ileostomy | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
Proposed publication must be submitted to Funder at least 60 days prior to the submission for publication. If Funder requests in writing, the proposed publication may be held for an additional 90 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Scientific Affairs | Accelerated Community Oncology Research Network, Inc. | 901-435-5570 | mwalker@acorncro.com |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000068196 | Albumin-Bound Paclitaxel |
| 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 |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
Not provided
Not provided
|
|
|
|