Phase II Study Of Pemetrexed Disodium In Combination With Either Gemcitabine Or Carboplatin In Patients With Advanced Malignant PleuralMesothelioma
This is a phase II Clinical Trial, the objective of which is to determine the effectiveness of pemetrexed disodium combined with either carboplatin or gemcitabine on malignant pleural Mesothelioma patients. The other objectives of this study include the determination of toxicity of this regimen and the survival time of the patients who had undergone this treatment. This study also tries to set up a correlation between smoking status and the outcomes in patients who have been treated by this routine.
The disease should be in the advanced state. The disease should be measurable and in this context it should be mentioned that positive bone scans and pleural effusions are not considered measurable. The participant would be excluded if he is a candidate for curative surgery and if he is suspected to have brain metastases. It is also required that the patients have not undergone a prior biologic therapy or Chemotherapy. However, a patient can be allowed to participate even after radiotherapy if it is found that at least 4 weeks had passed from day of radiotherapy. Similarly, patients who had undergone pleurodesis can be admitted only if the surgery had taken place at least 2 weeks before the study.
The maximum number of enrollment allowed is 60 and the minimum required is 32. In this multicenter study, patients are randomly incorporated into two Arms. The Arm I consists of patients who are given pemetrexed disodium IV for 10 minutes and then with carboplatin IV for the next 30 minutes. This is the routine for the first day. Patents in the Arm II are given pemetrexed disodium and then gemcitabine IV for half an hour on the first and the eighth days.
In both these groups, the course of treatment is repeated for every 21 days. There might be six courses depending upon the degree of toxicity and tolerance among the patients. All patients are given oral folic acid 5- 10 days before and 3 weeks after the completion of chemotherapy.