A Pemetrexed plus Gemcitabine or Carboplatin for Patients with Advanced Malignant Pleural Mesothelioma trial is currently being conducted and study is ongoing but no longer recruiting patients.
The trial is being held in 115 locations throughout the country, and its primary goal is to estimate response rates in patients who have advanced mesothelioma treated with pemetrexed disodium combined with either gemcitabine or carboplatin. The trial’s secondary goals include assessment of the toxicity of these regimens, estimation of the survival time in the patients treated, and the correlation of smoking status with treatment outcome.
The study was last updated on ClinicalTrials.gov on March 23, 2010 and currently has an enrollment of 32 patients. The study began in November, 2005 and is estimated completion is set for July, 2010.
Malignant mesothelioma is a rare type of cancer that occurs in the lining of the chest and/or abdomen. Mesothelioma cancer develops in individuals who have been exposed to airborne asbestos particles. Mesothelioma treatment typically involves surgery, radiation therapy, chemotherapy or a combination of the three and is, unfortunately, purely palliative, as there is no cure for mesothelioma.
Patients receive intravenous pemetrexed disodium over a period of 10 minutes and intravenous carboplatin over a period of 30 minutes through arm one on day one. Through arm two on days one and eight, patients receive intravenous pemetrexed disodium and gemcitabine over a period of 30 minutes. Treatment in both arms repeats every 21 days for up to six courses.
Both men and women 18 years of age or older were eligible to participate in the study, as long as they presented written informed consent. Patients had to have histologically confirmed advanced mesothelioma of the pleura and measurable disease as defined by RECIST criteria within four weeks of the study.
Recruits were allowed to have undergone pleurodesis. If this is the case, there had to be at least a two-week delay before the administration of pemetrexed medication. Patients had to have an ECOG performance status of 0 or 1 to participate and a normal organ and marrow function. They also had to be willing and able to take folic acid, Vitamin B12 and dexamethasone.
Patients were excluded from participation in the trial if they were candidates for curative surgery or if they have had prior radiation therapy to the target lesion. Recruits were not allowed to have prior systemic chemotherapy for mesothelioma or active infections, and patients with second primary malignancies, as well as those with known or suspected brain metastases, were unable to participate.
Women who were pregnant or breast feeding were also excluded from the trial, as were individuals who were visibly malnourished. Patients were not allowed to take aspirin or other anti-inflammatory drugs two days prior and subsequent to each pemetrexed administration.
Additional information may be found at http://www.cancer.gov/clinicaltrials/ECOG-E1B03
ClinicalTrials.gov identifier: NCT00101283.
The Mesothelioma and Asbestos Awareness Center promotes the efforts of clinical trials nationwide with the hope that a mesothelioma cure may be found. Patients who suffer from mesothelioma should speak with their oncologist to determine whether or not they are a good candidate for a particular trial. For more information about mesothelioma cancer and available treatments and to learn more about the nation’s leading thoracic oncologists, including Dr. David Sugarbaker, please visit the MAA Center website.
