NCT01742767

Cisplatinum/Pemetrexed Versus Split-dose Cisplatinum/Pemetrexed In NSCLC

Randomized Phase II Trial of Three-weekly Cisplatinum and Pemetrexed Versus Split-dose d1 and d8 Cisplatinum and Pemetrexed In Advanced and Inoperable Non-squamous Non-small-cell Lung Cancer (NSCLC)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Universität Duisburg-Essen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Cisplatinum and pemetrexed (ALIMTA®) has become an effective first-line regimen for advanced and inoperable non-squamous NSCLC without somatic activating mutations of epidermal growth factor receptor (EGFR). In the standard regimen the cisplatinum dose is 75 mg/m2 on day 1 of a 21-day cycle. Due to the high platinum-dose patients do need a strict hyperhydration and often have to be hospitalized for survey. Split-dose cisplatinum with two administrations on Day 1 and 8 of a 21-day-cycle has already been administered in other platin-containing chemotherapy regimens (cis/gem cis/nav cis/paclitaxel cis/docetaxel) with favourable toxicity profiles and generally with an excellent patient compliance.

Detailed description

There is a current need to develop a split-dose cisplatinum regimen in combination with pemetrexed with high efficacy, excellent treatment compliance, administration convenience and the possibility to open up easier outpatient administration of the chemotherapy protocol. Dosing of cisplatinum at 40 mg/m2 d 1 and day 8 seems to be very effective and useful for this strategy. The current trial will address this issue within a prospective randomized phase-II trial. Treatment will be given on day 1 and 8 in the split-dose arm. A comparator arm of the current three-weekly higher cisplatinum schedule will be added to this study. For evaluation of this strategy observation of the toxicity/efficacy ratio within this trial will be of major importance. Efficacy will be analyzed by objective response rate, symptom control and life-quality. Toxicity will be looked at with treatment toxicity, treatment compliance and adherence to protocol.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Cisplatinum
DRUG	Pemetrexed

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-05-01
• Completion: 2015-04-01
• First posted: 2012-12-05
• Last updated: 2012-12-05

Locations

1 site across 1 country: Germany