The CanBas, Co. Ltd. CBP501 + Pemetrexed + Cisplatin study, which is taking place in locations across the nation, including Arizona, California, Illinois, Michigan, Nevada, New Mexico, New York, Ohio, Pennsylvania, Texas and Utah, is currently recruiting patients with solid tumors and pleural mesothelioma.
The mesothelioma doctors leading the study intend to determine the MTD of CBP501 + pemetrexed + cisplatin in patients with advanced solid tumors in phase 1. The primary outcome of phase 2 is to evaluate the safety of CBP501 + pemetrexed + cisplatin in the patients.
The study’s secondary goals include determining the recommended CBP501 dose for phase 2 and to undertake a preliminary characterization of the safety of this pharmaceuticals combination. The study also aims to determine the pharmacokinetics of CBP501 when co-administered with cisplatin and pemetrexed, as well as to evaluate the pharmacodynamics of the triple combination.
The study, which was last updated on ClinicalTrials.gov on February 5, 2010, has an estimated enrollment of 72. The study began on June 16, 2008.
Malignant mesothelioma is a cancer of the lining of the chest and/or abdomen. Those with exposure to asbestos particles are more likely to develop the mesothelioma disease. Mesothelioma treatment typically includes surgery, radiation therapy, chemotherapy or a combination of the three.
Both men and women that are 18 years or older are eligible to participate in the study, as long as they provide informed consent. Patients with histologically confirmed solid malignancy and/or a cytologically confirmed diagnosis of pleural mesothelioma are eligible to participate. Patients must have measurable disease according to the mesothelioma guidelines in the modified RECIST. Recruits must also have an ECOG Performance Status of 0-2. Previous anticancer treatment must be discontinued at least three weeks prior to study. Patients must have a life expectancy of at least three months and adequate organ function.
Patients are excluded from the trial if they have had radiation therapy to more than 30% of the bone marrow prior to the study or if they have had mesothelioma originating outside the pleura. Patients without measurable lesions will not be included, and neither will patients with ongoing or active infections or uncontrolled medical disorders. History of another malignancy within 5 years of the study is another factor for exclusion, as well as any type of central nervous system or psychiatric disorder. Recruits with evidence of peripheral neuropathy greater than grade 1 will be excluded, as will patients who have treatment with any other investigational agents within 28 days prior to the study. Pregnant or breast feeding women are not allowed into the study and neither are individuals with known HIV, HBV or HCV infection or the presence of CNS metastases.
For additional information or for contact information for the doctor in charge of the study in your state, please visit: http://clinicaltrials.gov/ct2/show/NCT00700336?term=mesothelioma&rank=17
Please refer to this trial by its ClinicalTrials.gov identifier: NCT00700336
