Combination of CPT-11 and LoHP vs Combination of 5-FU, Leucovorin and LoHP as 1st Line Treatment in Gastric Patients

Sponsor
Hellenic Oncology Research Group
Study ID
NCT00447967
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
    Irinotecan 200 mg/m2 IV on Day 1 every 3 weeks for 6 cycles
  • Oxaliplatin — DRUG
    Oxaliplatin 80 mg/m2 IV on Day 2 every 3 weeks for 6 cycles
  • Fluorouracil — DRUG
    Fluorouracil 400 mg/m2 infused over 10 min IV and Fluorouracil600 mg/m2 infused over 22 hours IV, Day 1 and 2 (De Grammont regimen)every 2 weeks for 12 cycles
  • Leucovorin — DRUG
    Leucovorin 200 mg/m2 infused over 1 hour IV on day 1 and day 2 (De Grammont regimen) every 2 weeks for 12 cycles
  • Oxaliplatin — DRUG
    Oxaliplatin 85 mg/m2 as a 4 hour IV infusion, Day 1 every 4 weeks for 6 cycles

Study Details

This phase II trial will compare the efficacy and toxicity of the combination of Irinotecan and Oxaliplatin versus 5-FU/LV and Oxaliplatin as first line treatment in patients with locally advanced or metastatic gastric cancer

Key Dates

Start date
Jul 31, 2004
Status verified
Sep 2009
Primary completion
Sep 30, 2008
Completion
Sep 30, 2008

Study Design

Enrollment
110 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    IOX
  • Experimental: 2
    FLOX

Primary Outcome Measure

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

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