Second-Line Irinotecan vs. ILF for AGC
- Registration Number
- NCT00509964
- Lead Sponsor
- Gachon University Gil Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- histologically confirmed gastric cancer
- inoperable, recurrent, or metastatic
- performance status 0 to 2
- failed after one or more prior chemotherapy for advanced disease
- informed consent
Exclusion Criteria
- active infection
- severe co-morbidities
- previously treated with irinotecan or similar drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 ILF Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and infusional 5-fluorouracil, on day 1 every 2 weeks. 1 irinotecan Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method safety
Trial Locations
- Locations (1)
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of