Second-Line Irinotecan vs. ILF for AGC

Stomach Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00509964
• Other study ID #: GMO-GI-71
• 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
• 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

• Metastatic
• Second-Line
• Stomach Neoplasm
• Stomach Neoplasms

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