Second-Line Irinotecan vs. ILF for AGC
Conditions
Stomach Neoplasm - Metastatic - Second-Line
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: irinotecan Type: Drug
Name: ILF Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Gachon University Gil Medical Center
Incheon, Korea, Republic of
Status: Recruiting
Contact: Se Hoon Park, MD - +82 32 460 3682 - hematoma@gilhospital.com
Start Date
May 2007
Completion Date
July 2007
Sponsors
Gachon University Gil Medical Center
Source
Gachon University Gil Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page