NCT00447967 - Combination of CPT-11 and LoHP vs Combination of 5-FU, Leucovorin and LoHP as 1st Line Treatment in Gastric Patients | Biotech Hunter

Enrollment

110

Participants

Timeline

Start Date

July 31, 2004

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions

Gastric Cancer

Interventions

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

Trial Locations (8)

71110

University Hospital of Crete, Heraklion

Unknown

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupoli

"IASO General Hospital of Athens, 1st Dep of Medical Oncology", Athens

"Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine", Athens

401 Military Hospital of Athens, Athens

Air Forces Military Hospital of Athens, Athens

State General Hospital of Larissa, Larissa

"Metaxa's Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology", Piraeus