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Second-Line Irinotecan vs. ILF for AGC

NCT00509964 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2007-08-01

No results posted yet for this study

Summary

Patients with recurrent or metastatic gastric cancer can benefit from palliative chemotherapy. However, over half of patients with metastatic gastric cancer who received chemotherapy failed to achieve response and even in these responders, the duration of responses was as short as a few months. Patients with metastatic gastric cancer who fail to respond or have relapse after first line chemotherapy have a grim prognosis and a standard salvage treatment is not available.

We designed this phase II trial to determine the efficacy and safety of irinotecan monotherapy or combination (ILF) as second-line therapy for advanced gastric cancer.

Conditions

  • Stomach Neoplasm
  • Metastatic
  • Second-Line

Interventions

DRUG

irinotecan

Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.

DRUG

ILF

Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and 5-fluorouracil, on day 1 every 2 weeks.

Sponsors & Collaborators

  • Gachon University Gil Medical Center

    lead OTHER

Principal Investigators

  • Se Hoon Park, MD · Gachon University Gil Medical Center, Incheon, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Completion
2007-07-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT00509964 on ClinicalTrials.gov