Second-Line Irinotecan vs. ILF for AGC | NCT00509964

Studies
Second-Line Irinotecan vs. ILF for AGC

NCT00509964

Sponsor

Gachon University Gil Medical Center

Status

Unknown status

Last Update Posted

Aug 1, 2007Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Stomach Neoplasm
Metastatic
Second-Line

Interventions

irinotecan
ILF

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Not provided

Completion Date

Jul 2007Estimated

First Submitted Date

Jul 31, 2007

First Submission Date that Met QC Criteria

Jul 31, 2007

First Posted Date

Aug 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2007

Last Update Posted Date

Aug 1, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
irinotecan	Drug	Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.	1

Measure	Description	Time Frame
response rate

Measure	Description	Time Frame
safety

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dong Bok Shin, MD, PhD	Contact	82 32 460 3682		dbs@gilhospital.com

Overall Officials

Name	Affiliation	Role
Se Hoon Park, MD	Gachon University Gil Medical Center, Incheon, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gachon University Gil Medical Center	Recruiting	Incheon	Incheon	405 760	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077146	Irinotecan

Ancestor Terms

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided