ILF With/Without Cisplatin for Advanced Gastric Cancer

Gachon University Gil Medical Center

Status and phase: Unknown; Phase 2

Conditions: Stomach Neoplasm

Treatments: Drug: irinotecan; Drug: cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00320294

GMO-GI-52

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)