This research is being done to find out if pemetrexed and cisplatin work better when given together with an experimental drug called MORAb-009 in patients with malignant pleural mesothelioma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
89
MORAb-009 (Amatuximab) by IV on Days 1 and 8 every 21 days for 6 cycles.
Pemetrexed 500 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
Cisplatin 75 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6
Number of participants with PFS responders and non-responders at Month 6 was reported. PFS was defined as the time from the date of the first dose of amatuximab to the date of disease progression or death due to any cause, as determined by independent radiologist based on the modified Response Evaluation Criteria in Solid Tumors (RECIST) utilizing the total tumor measurement (performed by computerized tomography (CT)/magnetic resonance imaging (MRI)) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement. A "response", in terms of PFS, was defined to be at least a 6-month stabilization of disease. Progressive disease (PD) as measured by Modified RECIST was defined as an increase of at least 20 percent (%) in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions.
Time frame: Month 6
Overall Response Rate (ORR)
ORR, defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR) as determined by independent radiologist based on the modified RECIST utilizing the total tumor measurement (performed by CT/ MRI) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement. Tumor assessments performed up to the initiation of further anticancer therapy were considered. CR was defined as the disappearance of all target lesions with no evidence of tumor elsewhere, and PR was defined as at least a 30% reduction in the total tumor measurement. A confirmed response required a repeat observation on two occasions 4 weeks apart. ORR = CR + PR.
Time frame: From the date of first dose until evidence of CR or PR, up to approximately 5 years
Duration of Response (DR)
DR was derived for those participants who achieved a PFS Response and had an objective evidence of CR or PR. DR was defined as the time (in months) from first documentation of objective response (CR or PR) to the first documentation of disease progression or death \[as determined by independent radiologist based on the modified RECIST utilizing the total tumor measurement (performed by CT/ MRI) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement\]. Tumor assessments performed up to the initiation of further anticancer therapy were considered. CR was defined as the disappearance of all target lesions with no evidence of tumor elsewhere, and PR was defined as at least a 30% reduction in the total tumor measurement. PD as measured by Modified RECIST was defined as an increase of at least 20% in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions.
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University of Alabama, Birmingham
Birmingham, Alabama, United States
University of California, San Diego
La Jolla, California, United States
UCLA Medical Hematology & Oncology
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Christiana Care Health System
Newark, Delaware, United States
Emory University School of Medicine
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Johns Hopkins University--Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
NIH/National Cancer Institute
Bethesda, Maryland, United States
...and 18 more locations
Time frame: From the first documentation of objective response (CR or PR) to the first documentation of disease progression, up to approximately 5 years
Time to Tumor Response (TTR)
TTR was derived for those participants with objective evidence of CR or PR. TTR was defined as the time from the date of the first dose of amatuximab to first documentation of objective tumor response. CR was defined as the disappearance of all target lesions with no evidence of tumor elsewhere, and PR was defined as at least a 30% reduction in the total tumor measurement.
Time frame: From the date of the first dose to first documentation of objective response, up to approximately 5 years
Overall Survival (OS)
OS was defined as the time from the date of the first dose of amatuximab to the date of death.
Time frame: From the date of first dose to the date of death, up to approximately 5 years
Overall Progression Free Survival
Overall PFS was defined as the time from the date of first dose of amatuximab to the date of disease progression or death due to any cause. In the absence of confirmation of death, the survival time was censored at the date of the last follow-up contact. Tumor assessments performed up to the initiation of further anticancer therapy were considered. PD as measured by Modified RECIST was defined as an increase of at least 20% in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions.
Time frame: From the date of first dose of amatuximab to the date of disease progression, up to approximately 5 years