CanBas Co. Ltd. is conducting a new study, CBP501 + Pemetrexed + Cisplatin in Patients With Sold Tumors (Phase I) and Patients With Pleural Mesothelioma (Phase II). Currently, the study, which began in May of 2008, is planned for completion in December of 2010. Approximately 72 people will participate in the study.
The phase I part of the study is to determine the correct dosage of CBP501 combined with full-does cisplatin and pemetrexed. The ideal candidate is a patient with histologically confirmed solid malignancy that must be metastatic or unresctable (unable to be removed by surgery). The patient cannot have standard curative or palliative measures or those measures must have become ineffective. Typically in this situation, the first-line therapy would have been the prescription of cisplatin and pemetrexed. To determine the maximum tolerated does (MTD) of CBP501 researchers will look at the DLTs occurring during the first treatment cycle. Pharmacokinetics of the three drugs will be reviewed during the first phase.
Phase II will evaluate the full-dose of cisplatin and pemetrexed combined with the MTD of CBP501 determined in Phase I. This will be tested with malignant pleural mesothelioma patients that have not yet been treated for their illness and tumors are not able to be removed by surgery. The patients will be randomized into two different groups with a 2:1 ratio. The first group (Arm A) will receive pemetrexed, cisplatin and CBP501 while the second group (Arm B) will receive only pemetrexed and cisplatin. The randomization will be stratified by histology and performance status.
Cisplatin is an inorganic and water-soluble platinum complex. Once it undergoes hydrolysis it will react with DNA to produce intra and interstrand crosslinks. These crosslinks then impair replication and transcription of DNA. The toxins of cisplatin relate to the cellular arrest in the G2 phase of the cell cycle. Pemetrexed is a chemotherapy drug that has been commonly used to treat mesothelioma and non-small cell lung cancer.
Malignant pleural mesothelioma is a cancer of the pleura, a sac that contains the lungs and a thin membrane, the mesothelium. The membrane secretes a fluid that enables the lungs to expand and contract during breathing. Pleural mesothelioma is often developed after an exposure to asbestos where the airborne fibers are inhaled and become lodged in the soft lung tissue. Symptoms, such as chest pain, coughing or fluid around the lungs, can take between twenty and fifty years to appear, usually only in the late stages of the disease, making treatment difficult.
The study will be held in
For further information about mesothelioma cancer, please visit the Mesothelioma and Asbestos Awareness Center. The MAA Center is accredited by the Health On The Net Foundation and is recognized as a reliable source of information by DisabilityInfo.gov.
Sources:
National Cancer Institute
ClinicalTrials.gov
