Second-Line Irinotecan vs. ILF for AGC

Sponsor
Gachon University Gil Medical Center
Study ID
NCT00509964
Phase
PHASE2
Status
Unknown

Conditions

  • Metastatic
  • Second-Line
  • Stomach Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 31, 2007
Status verified
Jul 2007
Completion
Jul 31, 2007

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

response rate

Central Contacts

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