Study Of Induction Combination Chemotherapy Comprising Methotrexate, Vinorelbine Ditartrate, And Cisplatin With Or Without Surgery And Adjuvant Chemoradiotherapy In Malignant Pleural Mesothelioma Patients: Phase II
The heading can alternatively be described as combination chemotherapy with or without involving surgery and Chemo radiotherapy as a treatment for the malignant Pleural Mesothelioma patients. The Protocol IDs are CASE-CCF-IRB-5179, CASE-CCF-0755, and NCT00354393. The sponsor of this Phase II Clinical Trial is the NCI and it involves patients within 75 years of age. However, the trial is closed as of now.
The total enrollment consists of only 36 patients and the primary objective of the study is to assess the effect of induction combination chemotherapy consisting of vinorelbine ditartrate, cisplatin and Methotrexate on those malignant pleural Mesothelioma patients who have not undergone any treatment in the past.
Some of the secondary goals include assessment of the combination chemotherapy in lights of surgical success, its effect on quality of life, the degree of tolerance and toxicity, and lastly the determination of overall survival.
The first and foremost eligibility criteria is that patients must be capable of undergoing aggressive surgical procedures and that is disease must have been proved through histological tests. A vital condition that is required prior to this clinical trail is that the patients were not subjected to a radiotherapy, surgical resection, or chemotherapy before.
The WBC count of the patient must be atleast 3000 per cubic millimeter and a platelet count of 100,000 per cubic millimeter. Pregnant patients and those with other malignancies are excluded from this study. The enrollment criteria also require the use of contraception by fertile patients. The pulmonary function of the patients should be such that they can cope up with surgeries and radiotherapy.
In Induction Chemotherapy, patients receive cisplatin IV for 30-60 minutes on day 1 and vinorelbine ditartrate IV for 5-10 minutes and methotrexate IV for over 5-30 minutes on days 8, 15, and 22. The surgical procedures include pleurectomy and thoracotomy. Two additional courses of MVP Chemotherapy form the Adjuvant Chemotherapy.
After the completion of all these procedures, a patient is assessed on his quality of life for every three months.