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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Stomach Neoplasm

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate

Principal Investigator

Se Hoon Park, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gachon University Gil Medical Center, Incheon, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

GMO-GI-52

NCT ID:

NCT00320294

Start Date:

February 2005

Completion Date:

March 2007

Related Keywords:

  • Stomach Neoplasm
  • Neoplasms
  • Stomach Neoplasms

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