Metastatic, Second-Line, Stomach Neoplasm
Conditions
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.
Interventions
DRUGirinotecan
Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.
DRUGILF
Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and 5-fluorouracil, on day 1 every 2 weeks.
Sponsors
Gachon University Gil Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| safety | — |
Countries
South Korea
Contacts
Primary ContactDong Bok Shin, MD, PhD
Outcome results
None listed