Back to results

Second-Line Irinotecan vs. ILF for AGC

Primary Purpose

Stomach Neoplasm, Metastatic, Second-Line

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

irinotecan

ILF

About this trial

This is an interventional treatment trial for Stomach Neoplasm

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Gachon University Gil Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

safety

Full Information

NCT ID

NCT00509964

First Posted

July 31, 2007

Last Updated

July 31, 2007

Sponsor

Gachon University Gil Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00509964

Brief Title

Second-Line Irinotecan vs. ILF for AGC

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 Type

Interventional

2. Study Status

Record Verification Date

July 2007

Overall Recruitment Status

Unknown status

Study Start Date

May 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Gachon University Gil Medical Center

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stomach Neoplasm, Metastatic, Second-Line

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

irinotecan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

ILF

Intervention Description

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

Primary Outcome Measure Information:

Title

response rate

Secondary Outcome Measure Information:

Title

safety

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dong Bok Shin, MD, PhD

Phone

82 32 460 3682

dbs@gilhospital.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Se Hoon Park, MD

Organizational Affiliation

Gachon University Gil Medical Center, Incheon, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gachon University Gil Medical Center

City

Incheon

ZIP/Postal Code

405 760

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Se Hoon Park, MD

Phone

+82 32 460 3682

hematoma@gilhospital.com

12. IPD Sharing Statement

Learn more about this trial

Second-Line Irinotecan vs. ILF for AGC

We'll reach out to this number within 24 hrs