Mesothelioma Clinical Trial Alert: Pemetrexed (Alimta®) plus Cisplatin® trial seeking stage II participants

The University Health Network of Toronto, in collaboration with Eli Lilly and Company, is seeking patients with Malignant Pleural Mesothelioma to participate in a trial studying the effects of the combination of Pemetrexed with Cisplatin® on mesothelioma

Currently, complete removal of mesothelioma is only possible in 30% of patients who undergo surgical removal in conjunction with radiation therapy. To increase chances of complete cancer removal and decrease chances of cancer regrowth, the University Health Network of Toronto is studying the effects of the addition of Pemetrexed (Alimta®) plus Cisplatin® drugs prior to surgery and radiation.

This study, beginning in January 2009 and scheduled to end in January 2010, was last updated on ClinicalTrials.gov on March 8, 2010 and is seeking an enrollment of 45 patients.

Eligible patients must be diagnosed with mesothelioma, a rare cancer of the lining of the chest or abdomen that protects organs from day-to-day friction. Because this cancer is often detected at a late stage, patients on average only survive one to two years after detection. This cancer is primarily caused by exposure to asbestos. Once removed through surgery and radiation, the cancer frequently returns.

Patients interested in participating in the study may be male or female, but must be 18 years or older to participate. In addition, participants must agree to use contraceptives while participating and during the three months immediately following the trial. Female recruits must have a negative serum pregnancy test and may not breastfeed during the study.

Based on AJCC/UICC TNM staging criteria, participants must be M0; have T1, T2 or T3 disease (without cardiac involvement) or N0, N1 or N2 disease. On the ECOG performance status schedule, participants must score a status of zero to two. Recruits must also have an adequate bone marrow reserve, pass a pulmonary function test, and have the appropriate renal and hepatic function and a life expectancy of at least 12 weeks. The attending medical oncologist, thoracic surgeon and radiation oncologist must give patients permission to participate, and the participants must sign a consent form.

Patients may not have undergone mesothelioma chemotherapy, radiation or surgery and may not have taken intracavitary cytotoxic drugs or immunomodulators. If a patient has taken other unapproved drugs within 30 days prior or participated in this or a separate study of Pemetrexed in the past, he or she will be excluded. Participants must be willing to take folic acid, vitamin B12 supplementation or dexamethasone and be able to interrupt intake of aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period.

Participation will be denied to those who have serious concomitant systemic disorders and/or secondary malignancies, except in situ carcinoma of the cervix, treated non-melanomatous carcinoma of the skin, low grade localized adenocarcinoma of the prostate or any other malignancy treated over the previous two years without recurrence. 

If accepted, participants will receive 500 mg/m² of Pemetrexed and 75 mg/m² of Cisplatin every three weeks for three cycles.

Interested participants may contact Andrea Foster, 416-946-4501 ext 5010, Andrea.Foster@Uhn.on.ca.

Refer to the trial by its ClinicalTrials.gov identifier when inquiring: NCT00895648.

The Mesothelioma and Asbestos Awareness Center website provides up-to-date information about other mesothelioma clinical trials, and also offers additional content for those looking to learn more about their mesothelioma treatment options. It is important to speak with your oncologist before enrolling in a clinical trial or changing your cancer treatment regimen.