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| Name | Class |
|---|---|
| University of Chicago | OTHER |
| Columbia University | OTHER |
| Duke University | OTHER |
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To estimate the time to progression of cancer in patients with previously untreated mesothelioma receiving cisplatin, pemetrexed and bevacizumab
Secondary endpoints will include:
objective response rate
overall survival
In addition, the objective of the analysis of the correlative science data is to determine any association between tumor expression of VEGF/KDR complex and/or the presence of sv40 (as detected by PCR amplification) and objective response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | cisplatin, pemetrexed, and bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Drug | 15 mg/kg IV every 3 weeks |
| |
| cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival Rate at 6 Months | This is the percentage of patients alive and progression-free at 6 months from initiation of treatment. | patients progression free at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | response was assessed by the RECIST criteria (version 1.0). Per those criteria, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months |
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Inclusion criteria
5.2.1 Patients must have histologically proven malignant mesothelioma (epithelial, sarcomatoid, or mixed subtype) not amenable to curative surgery or radiotherapy. Eligible sites of origin include the pleura, peritoneum, and tunica vaginalis.
5.2.2 Patient's disease must not be amenable to curative treatment with surgery. Evidence of gross unresectability will include but not be limited to direct extension into the chest wall, mediastinal or hilar lymphadenopathy, pulmonary or cardiac function that is inadequate to tolerate resection, and sarcomatoid or mixed histology.
5.2.3 Patients must be > 18 years old 5.2.4 Patients must have measurable disease.
Adequate organ function and functional status
Exclusion Criteria:
a. General Medical Concerns 5.3.1 Patients must not be pregnant or breast feeding. 5.3.2 No "currently active" second malignancy other than non-melanoma skin cancer. Patients are not considered to have a "currently active" second malignancy if they have completed therapy and have a less than 30% risk of relapse.
5.3.3 No uncontrolled intercurrent illness including but not limited to: active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social situations that would limit compliance with study requirements.
5.3.4 No HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with study medications.
5.3.5 History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents used in the study.
5.3.6 Inability to interrupt aspirin or other non-steroidal medication for a 5 day period.
c. Bevacizumab-Specific Concerns
Subjects meeting any of the following criteria are ineligible for study entry:
5.3.7 Patients with brain metastases are excluded 5.3.8 History of myocardial infarction or CVA (stroke) within 6 months of study entry.
5.3.9 Evidence of bleeding diathesis or coagulopathy. Patients on therapeutic doses of coumadin are eligible as long as the INR is maintained in the range of 2-3 and there is no evidence of active bleeding.
5.3.10 Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study 5.3.11 Urine protein:creatinine ratio less than 1.0 at screening 5.3.12 Serious, non-healing wound, ulcer, or bone fracture
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan E Dowell, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-8852 | United States |
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Patients recruited from investigators clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Cisplatin, Pemetrexed and Bevacizumab | cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
one patient excluded due to ineligibility. That patient is included in the toxicity analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Cisplatin, Pemetrexed and Bevacizumab | cisplatin 75 mg/m2, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg IV every 3 weeks |
| 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 | Progression Free Survival Rate at 6 Months | This is the percentage of patients alive and progression-free at 6 months from initiation of treatment. | Posted | Number | percentage of participants | patients progression free at 6 months |
|
|
3 years 6 months
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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 | Experimental Arm | cisplatin, pemetrexed, and bevacizumab |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pulmonary embolus | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment | Grade 3/4 neutropenia only |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Dowell | UT Southwestern | 214-648-4180 | jonathan.dowell@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D002945 | Cisplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
75 mg/m2 IV every 3 weeks |
|
| pemetrexed | Drug | 500 mg/m2 every 3 weeks |
|
| Overall Survival | overall survival was measured from time of initiation of treatment to death from any cause | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up 100 months |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Response Rate | response was assessed by the RECIST criteria (version 1.0). Per those criteria, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Posted | Number | percentage of participants | from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months |
|
|
|
| Secondary | Overall Survival | overall survival was measured from time of initiation of treatment to death from any cause | Posted | Median | 95% Confidence Interval | months | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up 100 months |
|
|
|
| 16 |
| 53 |
| 24 |
| 53 |
| deep venous thrombosis | Vascular disorders | Non-systematic Assessment |
|
| RPLS | Nervous system disorders | Non-systematic Assessment |
|
| cerebrovascular accident | Nervous system disorders | Non-systematic Assessment |
|
| small bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dehydration | General disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| neutropenic fever | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| squamous cell carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment | Grade 3 and 4 only |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment | Grade 3 and 4 only |
|
| Fatigue | General disorders | Non-systematic Assessment | Grade 3 and 4 only |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | Grade 3 and 4 only |
|
| Dehydration | General disorders | Non-systematic Assessment | Grade 3 and 4 only |
|
| Neuropathy | Nervous system disorders | Non-systematic Assessment | Grade 3 and 4 only |
|
| Allergic reaction | Immune system disorders | Non-systematic Assessment | Grade 3 and 4 only |
|
| Anorexia | General disorders | Non-systematic Assessment | Grade 3 and 4 only |
|
| Creatinine | Renal and urinary disorders | Non-systematic Assessment | Grade 3 and 4 only |
|
| Mucositis | Gastrointestinal disorders | Non-systematic Assessment | Grade 3 and 4 only |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Grade 3 and 4 only |
|
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| D018301 |
| Neoplasms, Mesothelial |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |