The study to find the best dose of SU011248 when given with pemetrexed, Pemetrexed and Cisplatin or Pemetrexed and Carboplatin in patients with advanced solid tumors took place in Aurora, Colorado; Ottawa, Ontario; and Montreal, Quebec. The primary goal of the trial was to assess the maximum tolerated dose of SU011248, as well as its overall safety and antitumor activity when it was combined with Pemetrexed, Pemetrexed and Cisplatin, or Pemetrexed and Carboplatin in patients with advanced solid tumors.
In addition to obtaining additional mesothelioma information, the trial also sought to evaluate the plasma pharmacokinetics of SU011248 and its metabolite, as well as to assess its antitumor activity in patients with non-small cell lung cancer.
Malignant mesothelioma is a rare type of cancer in the lining of the chest or abdomen. Mesothelioma disease can be developed in those with exposure to airborne asbestos particles. Mesothelioma is typically treated in mesothelioma clinics with surgery, radiation therapy, chemotherapy, or a combination of the three. Mesothelioma prognosis is generally bleak, as there is no known cure for this aggressive type of cancer.
This study was last updated on ClinicalTrials.gov on May 15, 2010. The trial began in November, 2006 and was completed in April 2010 with a total enrollment of 96 participants.
Both men and women ages 18 and older were eligible to participate in the trial as long as they had a diagnosis of a solid cancer that was not responsive to standard therapy, or for which no standard therapy existed at the time of the study. The patient must also have had an ECOG performance of 0 or 1 in order to participate.
Patients were unable to participate in the clinical trial if they had received treatment with either Pemetrexedor SU011248 at any point prior to the study. Recruits with a history of coughing up large quantities of blood were unable to participate, although patients coughing up a small amount of blood were allowed to partake in the study. Patients with hypertension that could not be controlled by medication and those who were undergoing any other types of treatment were unable to participate in the clinical trial.
Patients were given daily doses of sunitinib via oral capsule in a continuous regimen for two weeks out of every three weeks during the entire length of the study. They were simultaneously given Alimta®, a particular brand of Pemetrexed medication, every three weeks. The same was done with Pemetrexed with Cisplatin or Pemetrexed with Carboplatin. The regimen continued until there was a progression of the disease or an unacceptable toxicity was found in the trial participants. For further information on the trial, visit: http://clinicaltrials.gov/ct2/show/NCT00528619?term=Alimta&rank=1. Please refer to this trial by its ClinicalTrials.gov identification number: NCT00528619
Mesothelioma.com recommends that patients with recently-diagnosed mesothelioma cancer speak with their oncologist about potential enrollment in a clinical trial. Many patients have experienced in an increase in their quality of life as a result of clinical trial participation. For additional information about mesothelioma cancer treatment and the availability of clinical trials, please visit Mesothelioma.com.
