Second-Line Irinotecan vs. ILF for AGC
A Randomized Phase II Trial of Irinotecan Monotherapy Versus Irinotecan, Leucovorin and 5-FU (ILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer Failing Prior Chemotherapy
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 31, 2007
CompletedFirst Posted
Study publicly available on registry
August 1, 2007
CompletedAugust 1, 2007
July 1, 2007
July 31, 2007
July 31, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
response rate
Secondary Outcomes (1)
safety
Study Arms (2)
1
ACTIVE COMPARATORPatients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.
2
ACTIVE COMPARATORPatients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and infusional 5-fluorouracil, on day 1 every 2 weeks.
Interventions
Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and 5-fluorouracil, on day 1 every 2 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- active infection
- severe co-morbidities
- previously treated with irinotecan or similar drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gachon University Gil Medical Center
Incheon, Incheon, 405 760, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Se Hoon Park, MD
Gachon University Gil Medical Center, Incheon, Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 31, 2007
First Posted
August 1, 2007
Study Start
May 1, 2007
Study Completion
July 1, 2007
Last Updated
August 1, 2007
Record last verified: 2007-07