PARAMOUNT trial
other names | PARAMOUNT, NCT00789373 |
---|---|
sponsor | Eli Lilly and Company |
number of participants | 939 |
start | November 2008 |
end | September 2013 |
primary completion | June 2010 |
The PARAMOUNT trial is a
PARAMOUNT found that maintenance therapy with pemetrexed for patients with advanced non-squamous NSCLC was an effective and well-tolerated treatment option in those patients who had not had progress after initial therapy with pemetrexed plus cisplatin.
Study design
Name
The full name of the trial is "A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care versus Best Supportive Care Immediately Following Induction Treatment with Pemetrexed + Cisplatin for Advanced Non-Squamous Non-Small Cell Lung Cancer". Its common name is PARAMOUNT. Its ClinicalTrials.gov identifier is NCT00789373.
Purpose
The PARAMOUNT trial investigated whether treatment with a
For patients with advanced
Studies prior to PARAMOUNT had shown pemetrexed, an antifolate, had been an effective therapy for patients with NSCLC when used either as an initial chemotherapy with cisplatin or as a maintenance drug when not part of the initial therapy.[2][4] The PARAMOUNT study was designed to measure the extent of the efficacy when a patient received pemetrexed maintenance therapy after cisplatin/pemetrexed initial therapy.[2] The study would measure progression-free survival of patients and survival irrespective of whether the cancer had progressed.[2] An additional study goal would be to check the extent to which measurement of thymidylate synthase - the naturally produced enzyme on which pemetrexed acts - could predict the efficacy of pemetrexed in these cases.[2]
Outcome
PARAMOUNT found that maintenance therapy with pemetrexed for patients with advanced non-squamous NSCLC was an effective and well tolerated treatment option in those patients who had not had progress after initial therapy with pemetrexed plus cisplatin.[1] The average life of all participants receiving the experimental treatment increased more than 13 months as compared to the control group.[5] The results of this trial should not be generalized beyond the scope of the research and the trial design must be considered to interpret these results.[6]
The result of this trial did not change the fact that the concept of maintenance therapy remains controversial and complicated.[7]
Study participants
The study intended to enroll 939 people.[8] The study started in November 2008 and was estimated to be completed in September 2013.[8] The study was conducted at locations in Australia, Belgium, Finland, France, Germany, Greece, India, Italy, the Netherlands, Poland, Portugal, Romania, Spain, Turkey, and the United Kingdom.[8]
Among other
References
- ^ PMID 22341744.
- ^ PMID 20211022.
- S2CID 6657623.
- PMID 19852529.
- ^ Bankhead, Charles (8 June 2012). "ASCO: Alimta Extends Survival in NSCLC". MedPage Today. Retrieved 16 September 2013.
- PMID 20679540.
- S2CID 71344182.
- ^ clinicaltrials.gov. National Institutes of Health. Retrieved 14 September 2013.