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Second-Line Irinotecan vs. ILF for AGC

NCT ID: NCT00509964

Last Updated: 2007-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stomach Neoplasm Metastatic Second-Line

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

irinotecan

Intervention Type DRUG

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

2

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

Group Type ACTIVE_COMPARATOR

ILF

Intervention Type DRUG

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

Interventions

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irinotecan

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

Intervention Type DRUG

ILF

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Se Hoon Park, MD

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center, Incheon, Korea

Locations

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Gachon University Gil Medical Center

Incheon, Incheon, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong Bok Shin, MD, PhD

Role: CONTACT

[email protected]
82 32 460 3682

Facility Contacts

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Se Hoon Park, MD

Role: primary

[email protected]
+82 32 460 3682

Other Identifiers

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GMO-GI-71

Identifier Type: -

Identifier Source: org_study_id