Overview

This trial is active, not recruiting.

Condition stomach neoplasm
Treatments irinotecan, cisplatin
Phase phase 2
Sponsor Gachon University Gil Medical Center
Start date February 2005
End date March 2007
Trial size 86 participants
Trial identifier NCT00320294, GMO-GI-52

Summary

To compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Objective response rate
time frame:
Safety
time frame:

Secondary Outcomes

Measure
Progression-free survival
time frame:
Overall survival
time frame:
Quality of life
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Histologically proven gastric adenocarcinoma - Advanced, metastatic or recurrent - ECOG performance status 0 to 2 - No prior chemotherapy - Measurable or evaluable indicator lesion(s) - Normal marrow, hepatic and renal functions - Provision of written informed consent Exclusion Criteria: - Active infection, bleeding or severe comorbidities - Pregnant or breastfed women - Active CNS metastasis

Additional Information

Official title A Randomized Trial of Irinotecan, Leucovorin, 5-FU (ILF) Versus ILF Plus Cisplatin (PILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer
Principal investigator Se Hoon Park, MD
Description Irinotecan, in combination with 5-FU or cisplatin, clearly demonstrated efficacy against gastric cancer. A previous randomized study of ILF regimen versus IP in patients with AGC showed that the ILF produced an overall response rate of 42% and a median survival of 10.7 months, which were significantly better than the results with IP regimen [Pozzo C, et al. Ann Oncol 2004]. However, since cisplatin is still considered one of the key drugs for the treatment of gastric cancer, a combination of these four drugs (irinotecan, leucovorin, FU and cisplatin) seemed to be a promising strategy for advanced AGC. We desinged this randomized phase II study to compare the combination of irinotecan, leucovorin and 5-FU (ILF) with ILF plus cisplatin (PILF) as first-line chemotherapy in patients with measurable metastatic gastric cancer.
Trial information was received from ClinicalTrials.gov and was last updated in March 2007.
Information provided to ClinicalTrials.gov by Gachon University Gil Medical Center.