NCT00447967

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

A Randomized Phase II Study of Irinotecan and Oxaliplatin Versus the Combination of 5-FU/LV and Oxaliplatin, as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

There is no regimen considered standard in advanced gastric cancer. The reported response rates of 5-FU-based combination chemotherapy are higher than single agents (10-50%) but more toxic. The combination of 5-FU/LV and LOHP has demonstrated an ORR of 43%, median TTP of approximately 6,5 months and OS of 8,6 months in phase II trials, with an acceptable toxicity. Irinotecan (CPT-11) is effective as salvage treatment in metastatic gastric cancer and has a synergistic activity with LOHP in preclinical trials

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan	Irinotecan 200 mg/m2 IV on Day 1 every 3 weeks for 6 cycles
DRUG	Oxaliplatin	Oxaliplatin 80 mg/m2 IV on Day 2 every 3 weeks for 6 cycles
DRUG	Fluorouracil	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
DRUG	Leucovorin	Leucovorin 200 mg/m2 infused over 1 hour IV on day 1 and day 2 (De Grammont regimen) every 2 weeks for 12 cycles
DRUG	Oxaliplatin	Oxaliplatin 85 mg/m2 as a 4 hour IV infusion, Day 1 every 4 weeks for 6 cycles

Timeline

• Start date: 2004-07-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-03-15
• Last updated: 2009-09-28

Locations

8 sites across 1 country: Greece