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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01229 | Registry Identifier | Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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Purpose of this study is to determine the effectiveness of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma.
The purpose of this study is to test the effectiveness, safety, and tolerability of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma. This is a phase II,open label,single center study. Patients will receive carboplatin, paclitaxel, and bevacizumab in an outpatient center by intravenous administration. The primary objectives is to study the progression free survival at 24 months after initiation of treatment and to determine the toxicity profile of the drug combinations. The secondary objectives are to estimate the overall survival and tumor response for this group of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carboplatin/paclitaxel with bevacizumab | Experimental | A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Patients With Progression Free Survival (PFS) | Progressive Disease (PD) is defined at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions. | up to 57 months |
| Measure | Description | Time Frame |
|---|---|---|
| To Estimate Overall Survival | up to 24 months | |
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability. | Toxicities will be assessed by using the NCI Common Toxicity Criteria for Adverse Events 3.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David O'Malley, MD | The Ohio State University Division of Gyn Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University-Division of Gyn Oncology | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carboplatin/Paclitaxel With Bevacizumab | A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles. Carboplatin: AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles. Paclitaxel: 175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles. bevacizumab: 15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carboplatin/Paclitaxel With Bevacizumab | A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles. Carboplatin: AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles. Paclitaxel: 175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles. bevacizumab: 15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles. |
| 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 |
| 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 | Evaluate Patients With Progression Free Survival (PFS) | Progressive Disease (PD) is defined at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions. | Posted | Median | Full Range | months | up to 57 months |
|
2 years
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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 | Carboplatin/Paclitaxel With Bevacizumab | A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles. Carboplatin: AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles. Paclitaxel: 175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles. bevacizumab: 15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Evisceration- fascia dehiscence | Injury, poisoning and procedural complications | CTCAE v. 5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Creatinine | Investigations | CTCAE v. 5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David O'Malley | The Ohio State University Comprehensive Cancer Center | 614-293-3873 | David.O'Malley@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2010 | Jan 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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| Paclitaxel | Drug | 175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles. |
|
|
| bevacizumab | Drug | 15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles. |
|
|
| up to 24 months |
| Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria | Tumor response will be evaluated using modified RECIST criteria with the following definitions. Complete Response (CR) is disappearance of gross evidence of disease with confirmation at least 4 weeks later. Partial Response (PR) is a 30% or greater reduction in measurement of longest dimension of each lesion with confirmation at least 4 weeks later. Progressive Disease (PD) is at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions. Stable Disease (SD) is any condition not meeting the other criteria for CR, PR or PD. | Up to 24 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | To Estimate Overall Survival | Two participants did not complete all 24 months of follow-up and are were not analyzed for this outcome measure. | Posted | Number | percentage of participants | up to 24 months |
|
|
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| Secondary | Number of Patients With Adverse Events as a Measure of Safety and Tolerability. | Toxicities will be assessed by using the NCI Common Toxicity Criteria for Adverse Events 3.0 | Posted | Number | participants | up to 24 months |
|
|
|
| Secondary | Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria | Tumor response will be evaluated using modified RECIST criteria with the following definitions. Complete Response (CR) is disappearance of gross evidence of disease with confirmation at least 4 weeks later. Partial Response (PR) is a 30% or greater reduction in measurement of longest dimension of each lesion with confirmation at least 4 weeks later. Progressive Disease (PD) is at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions. Stable Disease (SD) is any condition not meeting the other criteria for CR, PR or PD. | Two patients did not complete all 24 months of follow up and were not analyzed for this outcome measure. | Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| 11 |
| 38 |
| 4 |
| 38 |
| 38 |
| 38 |
| Evisceration- vaginal dehiscence | Injury, poisoning and procedural complications | CTCAE v. 5.0 | Systematic Assessment |
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| Pulmonary embolism | Vascular disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Neutropenic sepsis | Infections and infestations | CTCAE v. 5.0 | Systematic Assessment |
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| Allergy/Immunology | Immune system disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Neutrophils/granulocytes | Investigations | CTCAE v. 5.0 | Systematic Assessment |
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| Auditory/Hearing- other | Ear and labyrinth disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Cardiovascular Disorders | Cardiac disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Coagulation | Investigations | CTCAE v. 5.0 | Systematic Assessment |
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| Constaipation | Gastrointestinal disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Dermatology disorders | Skin and subcutaneous tissue disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Increased Liver Enzymes | Investigations | CTCAE v. 5.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Hemoglobin | Blood and lymphatic system disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Hemorrhage | Gastrointestinal disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Infection clinically documented | Infections and infestations | CTCAE v. 5.0 | Systematic Assessment |
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| Lymphatics | Blood and lymphatic system disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Mucositis/stomatis | Gastrointestinal disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Ocular/visual | Eye disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Other constitutional toxicity | General disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Other GI toxicity | Gastrointestinal disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Other infection toxicity | Infections and infestations | CTCAE v. 5.0 | Systematic Assessment |
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| Other metabolic/lab toxicity | Investigations | CTCAE v. 5.0 | Systematic Assessment |
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| Other neurologic toxicity | Nervous system disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Other pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Mood alteration | Psychiatric disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Taste alteration | Nervous system disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Pain, not specified | General disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Sensory neuropathy | Nervous system disorders | CTCAE v. 5.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE v. 5.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE v. 5.0 | Systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE v. 5.0 | Systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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 |
| Progressive Disease |
|
| Unable to Determine |
|
| Zero Measurable Disease |
|