At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 795 enrolled
Drug / intervention
pemetrexed +2 moredrug
Likely dose
pemetrexed 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase 3 Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Monotherapy in Patients With Recurrent or Metastatic Head and Neck Cancer
In Brief
A Phase 3 clinical trial evaluating pemetrexed, cisplatin, and 1 other intervention for Head and Neck Neoplasms. Completed, enrolled 795 participants across 94 sites in 21 countries.
Detailed Summary
This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Neoplasms
CountriesArgentina, Belgium, Brazil, China, Denmark, France, Germany, Hungary, India, Italy, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedDec 2006
Primary CompletionMar 2010
TodayJul 2026
First PostedDec 22, 2006
Enrollment StartDec 1, 2006
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.5 years ago
Interventions
pemetrexeddrug
500 mg/m\^2, IV, every 21 days, six 21 day cycles
cisplatindrug
75 mg/m\^2, administered IV, every 21 days, six 21 day cycles
placebodrug
Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles