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Raltitrexed Alone May Be Helpful in Treating Pleural Mesothelioma, Study Shows
Pleural Mesothelioma Clinical Trial Using Raltitrexed:
February 14, 2003 — Researchers in the Netherlands investigated the use of raltitrexed (Tomudex®) as a treatment for patients with pleural mesothelioma (Eur J Cancer 2003 Feb; 39(3): 353–7). Raltitrexed works by interfering with the ability of tumor cells to multiply and make deoxyribonucleic acid or DNA.
The twenty–four pleural mesothelioma patients who took part in the study received raltitrexed intravenously every 3 weeks, continuing for eight cycles in those who experienced no serious toxic reactions. They had not previously been exposed to chemotherapy.
Five patients or 20.8% had a partial favorable response to raltitrexed. Toxicity was mild, with diarrhea, nausea, and vomiting as the major side–effects. The researchers concluded that raltitrexed used alone showed promise as a treatment for pleural mesothelioma. They recommended further clinical tests on raltitrexed’s effects.
The raltitrexed study is a “phase II” clinical trial, as defined by the European Organization for Research and Treatment of Cancer. A clinical trial is a study with human subjects to determine the safety and effectiveness of a new drug or treatment. A phase II trial determines the activity of a new treatment on a type of cancer; it involves a small to moderate number of patients. A phase II trial is more advanced than a phase I trial, which is concerned with the safety of a new treatment and how to administer it. A phase III trial compares the effects of a new treatment with a standard treatment, and requires the largest number of participants.
Recently, raltitrexed was used in combination with oxaliplatin in a phase II pleural mesothelioma clinical trial, with encouraging results (See Raltitrexed and Oxaliplatin Evaluated for Treating Mesothelioma). Raltitrexed has also been tested as a treatment for colorectal cancer in patients who had undergone chemotherapy (Anticancer Drugs 1999 Sep; 10(8): 741–8). The results were promising.
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