Chemotherapy Used in Pleural Mesothelioma Treatment

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Raltitrexed and Oxaliplatin Evaluated for Treating Pleural Mesothelioma

Pleural Mesothelioma Clinical Trial with Raltitrexed and Oxaliplatin:

January 24, 2003 — French researchers studied the effects of treating pleural mesothelioma patients with a combination of raltitrexed (Tomudex; AstraZeneca, Cergy, France) and oxaliplatin (J Clin Oncol 2003 Jan 15; 21(2): 349–54). Raltitrexed inhibits tumor cells from multiplying by interfering with their ability to make deoxyribonucleic acid or DNA. Oxaliplatin is an anticancer drug that belongs to the family of platinum compounds.

Seventy pleural mesothelioma patients took part in the study. Their median age was 60. Fifteen had been treated with chemotherapy (“pretreated patients”) and 55 had never been treated with chemotherapy. All patients received raltitrexed followed by oxaliplatin every three weeks.

Fourteen pleural mesothelioma patients (20%) had a partial response, and 32 patients (46%) had stable disease. Among those patients who had never been treated with chemotherapy, the median survival was 31 weeks from the time of raltitrexed/oxaliplatin treatment. In pretreated patients, the median survival was 44 weeks from the start of treatment. The one–year survival rate was 40% in pretreated patients and 26% in those who had not been pretreated.

A Phase II Clinical Trial to Test Drug Safety and Effectiveness

There were no treatment–related deaths, and blood toxicity reactions were mild. Some patients experienced weakness, nausea, and sensory disturbances. The researchers concluded that raltitrexed/oxaliplatin treatment showed some treatment potential.

The raltitrexed/oxaliplatin research was considered a phase II clinical trial. It followed a promising phase I clinical trial of 11 patients, 6 of whom showed some improvement with the combined treatment.

A phase I trial involves only a few patients, focuses on what drug dosage is safe, and helps determine how often and in what way a drug should be administered. A phase II trial continues to evaluate the safety and effectiveness of a drug. Typically, it includes more patients than does the phase I clinical trial.