Irinotecan Plus Cisplatin vs Pemetrexed Plus Cisplatin as 2nd Line in NSCLC Stage IIIB/IV

Sponsor
Hellenic Oncology Research Group
Study ID
NCT00614965
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Irinotecan at the dose of 110 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
  • Cisplatin — DRUG
    Cisplatin at the dose of 80 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
  • Pemetrexed — DRUG
    Pemetrexed at the dose of 500mg/m2 IV every 3 weeks for 6 consecutive cycles

Study Details

This trial will compare the efficacy of irinotecan/cisplatin and pemetrexed/cisplatin in the second-line treatment of patients with stage IIIB/IV NSCLC

Key Dates

Start date
Nov 30, 2006
Status verified
May 2011
Primary completion
Mar 31, 2010
Completion
Mar 31, 2010

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    IC
  • Experimental: 2
    PC

Primary Outcome Measure

Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ]

Related Studies