Second-Line Irinotecan vs. ILF for AGC

Sponsor

Gachon University Gil Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00509964

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

24.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasm Metastatic Second-Line	Drug: irinotecan Drug: ILF	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

May 1, 2007

Anticipated Study Completion Date :

Jul 1, 2007

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: 1

Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.

Drug: irinotecan

Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.

Active Comparator: 2

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

Drug: ILF

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

Outcome Measures

Primary Outcome Measures

response rate []

Secondary Outcome Measures

safety []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gachon University Gil Medical Center	Incheon		Korea, Republic of	405 760

Sponsors and Collaborators

Gachon University Gil Medical Center

Investigators

Principal Investigator: Se Hoon Park, MD, Gachon University Gil Medical Center, Incheon, Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00509964

Other Study ID Numbers:

GMO-GI-71

First Posted:

Aug 1, 2007

Last Update Posted:

Aug 1, 2007

Last Verified:

Jul 1, 2007

Additional relevant MeSH terms:

Stomach Neoplasms

Irinotecan

Study Results

No Results Posted as of Aug 1, 2007