ILF With/Without Cisplatin for Advanced Gastric Cancer

Stomach Neoplasm Clinical Trial

Official title:

A Randomized Trial of Irinotecan, Leucovorin, 5-FU (ILF) Versus ILF Plus Cisplatin (PILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00320294
• Other study ID #: GMO-GI-52
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 1, 2006
• Last updated: March 9, 2007
• Start date: February 2005
• Est. completion date: March 2007

Study information

• Verified date: March 2007
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Drug:
• irinotecan

• cisplatin

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate
Primary	Safety
Secondary	Progression-free survival
Secondary	Overall survival
Secondary	Quality of life