A Phase II Randomized Trial Assessing the Combination of Gemcitabine and Pemetrexed in the First Line Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Patients with stage IIIB or IV non-small cell lung cancer will be randomly allocated to
receive: (a)PG regimen: paclitaxel 120 mg/sqm followed by gemcitabine 1,000 mg/sqm i.v. on
days 1 & 8 q 3 weeks; (b)GA regimen: gemcitabine 1,250 mg/sqm i.v. on day 1 (plus folinic
acid 350 μg daily orally and vitamin B12 1,000 μg i.m. q 9 weeks), pemetrexed (Alimta®) 500
mg/sqm i.v. on day 8 followed by gemcitabine 1,250 mg/sqm, q 3 weeks.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate of patients treated with the gemcitabine plus Alimta regimen
after 3 cycles
Yes
Pasquale Comella, MD
Principal Investigator
National Tumor Institute, Naples, Italy
Italy: Ministry of Health
SICOG trial 0506
NCT00434135
May 2006
October 2008
Name | Location |
---|