At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating Pemetrexed Phase 1, Cisplatin Phase 1, and 3 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 49 participants across 4 sites.
Detailed Summary
Measure the 1 year survival of non small cell lung cancer (NSCLC) patients who are being treated with pemetrexed in combination with cisplatin and radiation.
Study Details
Timeline
Interventions
300 mg/m\^2 IV, Days 1 and 22; intermediate dose escalation level of 400 mg/m\^2 IV; then 500 mg/m\^2 IV, repeated every 21 days (q 21 days) x 2 cycles
Cohorts 1-3: 25 mg/m\^2 IV, Days 1-3 and 22-24 then 75 mg/m\^2 IV, q21 days x 2 cycles Cohort 4 carried into Phase 2: 20 mg/m\^2 IV, Days 1-5 and 22-26 then 75 mg/m\^2 IV, q21 days x 2 cycles.
Phases 1 and 2: 61-65 Gy in 33-35 fractions
Concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m\^2 IV on Days 1 and 22.
Phase 2 (Cohort 4 carried over from Phase 1): 20 mg/m\^2 IV, Days 1-5 and 22-26 then 75 mg/m\^2 IV, q21 days x 2 cycles.