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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00509964
Other study ID # GMO-GI-71
Secondary ID
Status Recruiting
Phase Phase 2
First received July 31, 2007
Last updated July 31, 2007
Start date May 2007
Est. completion date July 2007

Study information

Verified date July 2007
Source Gachon University Gil Medical Center
Contact Dong Bok Shin, MD, PhD
Phone 82 32 460 3682
Email dbs@gilhospital.com
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Gachon University Gil Medical Center Incheon

Sponsors (1)

Lead Sponsor Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary response rate
Secondary safety
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