MedTrace Logo

Phase III Trial of DP Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer

NCT00313872 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-01-12

No results posted yet for this study

Summary

To assess the optimal sequence of the palliative chemotherapy regimen (DP --\> FOLFIRI vs FOLFIRI --\> DP) in metastatic gastric cancer patients.

Conditions

Interventions

DRUG

DP

D1 Taxotere 75 mg/m2 + D5W 200 mL IV over 1 hr D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr Pre \& Post medication Dexamethasone 8mg PO D0 Night (X1) D1 immediately upon waking in the morning, 1 hour before infusion Taxotere, Night (X3) D0 NS 1500 mL IV overnight hydration D1 DNK2 1000 mL IV over 2 hours, pre \& post hydration (if Mg \<WNL, mix MgSO4 1 amp) 20% Mannitol 70 mL IV full dripping, 30 mins before cisplatin D2-D3 Dexamethasone 8 mg PO bid, D4-D5 Dexamethasone 4 mg PO bid every 3 weeks

DRUG

FOLFIRI

FOLFIRI regimen D1 Irinotecan 150 mg/m2 + D5W 500mL MIV over 90 min D1 Leucovorin 100 mg/m2 + D5W 500mL MIV over 2hrs D1-2 5-FU 1500 mg/m2 + D5W 1000 ml CIV over 24 hrs (total 2doses) D1 atropine 0.3mg SQ before irinotecan

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Won Ki Kang, MD · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2009-06-30
Completion
2010-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00313872 on ClinicalTrials.gov