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| ID | Type | Description | Link |
|---|---|---|---|
| DOXILOVC2007 | Other Identifier | Johnson & Johnson Pharmaceutical Research and Development |
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| Name | Class |
|---|---|
| Centocor Ortho Biotech Services, L.L.C. | INDUSTRY |
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The purpose of this study is to evaluate the response rate (Complete Response (CR) and Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal cancers. All patients will received DOXIL, carboplatin and bevacizumab for a maximum of ten 28-day cycles. Patients will be followed for six months following treatment to assess progression-free survival.
DOXIL pegylated liposomal doxorubicin (PLD) is approved for use in patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. Data suggest that combination therapy of carboplatin plus DOXIL provides superior benefit to single agent therapy. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, is approved for use in combination with intravenous 5-fluorouracil-based chemotherapy for the treatment of metastatic colorectal cancer and in combination with carboplatin and paclitaxel (treatment of non-small cell lung cancer); and with paclitaxel (first line treatment of metastatic HER2-negative breast cancer). There are data showing bevacizumab has activity in the treatment of ovarian cancer, and it is currently being studied in platinum-sensitive relapsed ovarian cancer in combination with carboplatin/gemcitabine. No data exist on the efficacy and safety of bevacizumab administered with carboplatin and DOXIL. Based on the growing interest of incorporating bevacizumab in to ovarian cancer treatment and the activity seen to date, the evaluation of the combination of carboplatin and DOXIL with bevacizumab is warranted. This is a single arm (one dosing regimen), multicenter, open label (both the patient and the physician know what drug is being given) study in patients with platinum-sensitive recurrent ovarian, fallopian tube or primary peritoneal cancers. This study will be conducted in multiple sites across the United States. All patients will receive DOXIL, carboplatin and bevacizumab by intravenous (IV) infusion for a maximum of ten (10) 28-day cycles. A disease response assessment will occur after the completion of Cycles 2, 4, 6, 8 and at the end of treatment. Patients will be followed for six (6) months post-treatment for progression-free survival. Disease progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST). RECIST is an accepted classification for response to treatment with classifications of Complete Response (CR), Partial Response( (PR), Progressive Disease (PD) or Stable Disease (SD).The primary objective of this study is to evaluate the objective response rate (Complete Response (CR) and Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal cancers. The secondary objectives are to assess the safety profile of carboplatin and DOXIL in combination with bevacizumab as well as the following efficacy endpoints: Duration of response, Progression-free Survival, and Time to Progression. Safety will be evaluated using adverse events, clinical laboratory tests, and tests for cardiac function after the first 20 patients have been entered and received at least 2 cycles of therapy. Overall safety will be summarized at study completion. DOXIL (30 mg/m2), and carboplatin (area under the curve (AUC 5)) will be given on Day 1 of each 28-day cycle. Bevacizumab (10 mg/kg) will be given on days 1 and 15 of every 28-day cycle. All treatment will be given by intravenous (IV) infusion and repeated every 4 weeks for up to 10 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxorubicin HCL liposome; bevacizumab; carboplatin | Drug | 30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Efficacy End Point is the Number of Patients With an Objective Response. | Objective Response Rate to Treatment is defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR). A Complete Response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD | Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Efficacy Endpoints is Duration of Objective Response. | Objective Response Rate to Treatment Defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR) Where a Complete response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Duration of response: Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracey McGowan, MD | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horsham | Pennsylvania | 19044 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | DOXIL/CARBOPLATIN/BEVACIZUMAB | Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease. |
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| ID | Title | Description |
|---|---|---|
| BG000 | DOXIL/CARBOPLATIN/BEVACIZUMAB | Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | The Primary Efficacy End Point is the Number of Patients With an Objective Response. | Objective Response Rate to Treatment is defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR). A Complete Response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD | ITT | Posted | Oct 2011 | Number | Participants | Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days) |
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| Secondary | The Secondary Efficacy Endpoints is Duration of Objective Response. | Objective Response Rate to Treatment Defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR) Where a Complete response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Duration of response: Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease. | ITT | Posted | Oct 2011 | Median | Full Range | Days | Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease. |
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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 | DOXIL/CARBOPLATIN/BEVACIZUMAB | Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention. | 15 | 54 | 53 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Large Intestinal Obstruction | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Small Intestinal Perforation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Abdominal Abscess | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Staphylococcal Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Corneal Abrasion | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
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| Device Malfunction | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
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| Device Occlusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Ureteric Obstruction | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Mucosal Inflammation | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Feeling Hot | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Oedema | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Gingival Bleeding | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Neuropathy Peripheral | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Memory Impairment | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Sinus Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hot Flush | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Neutrophil Count Decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
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| Weight Decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director | Janssen Services, LLC | 1 215 325-5329 | tmcgowan@its.jnj.com |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D000008 | Abdominal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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