Mesothelioma
Conditions
Keywords
mesothelioma, bevacizumab, chemotherapy
Brief summary
To estimate the time to progression of cancer in patients with previously untreated mesothelioma receiving cisplatin, pemetrexed and bevacizumab
Detailed description
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.
Interventions
DRUGbevacizumab
15 mg/kg IV every 3 weeks
DRUGcisplatin
75 mg/m2 IV every 3 weeks
DRUGpemetrexed
500 mg/m2 every 3 weeks
Sponsors
University of Chicago
Columbia University
Duke University
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival Rate at 6 Months | patients progression free at 6 months | This is the percentage of patients alive and progression-free at 6 months from initiation of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months | 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. |
| Overall Survival | 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 | overall survival was measured from time of initiation of treatment to death from any cause |
Countries
United States
Participant flow
Recruitment details
Patients recruited from investigators clinics
Participants by arm
| Arm | Count |
|---|---|
| Cisplatin, Pemetrexed and Bevacizumab cisplatin 75 mg/m2, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg IV every 3 weeks | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | Cisplatin, Pemetrexed and Bevacizumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 28 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 66 years |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 24 / 53 |
| serious Total, serious adverse events | 16 / 53 |
Outcome results
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.
Time frame: patients progression free at 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cisplatin, Pemetrexed, Bevacizumab | Progression Free Survival Rate at 6 Months | 56 percentage of participants |
Secondary
Overall Survival
overall survival was measured from time of initiation of treatment to death from any cause
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cisplatin, Pemetrexed, Bevacizumab | Overall Survival | 14.8 months |
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.
Time frame: from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cisplatin, Pemetrexed, Bevacizumab | Response Rate | 40 percentage of participants |