Biweekly FOLFIRI in Advanced Gastric Cancer (AGC) With Fa... | NCT00976768

Studies
Biweekly FOLFIRI in Advanced Gastric Cancer (AGC) With Failure of Prior Taxane, Fluoropyrimidine, and Cisplatin

NCT00976768

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Jan 7, 2020Actual

Enrollment

44Actual

Phase

Phase 2

Conditions

Advanced Gastric Cancer

Interventions

oxaliplatin, 5-fluorouracil

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

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Sep 11, 2009

First Submission Date that Met QC Criteria

Sep 11, 2009

First Posted Date

Sep 14, 2009Estimated

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

Jan 6, 2020

Last Update Posted Date

Jan 7, 2020Actual

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

The purpose of this study is:

To observe the feasibility of biweekly oxaliplatin and infusional 5-fluorouracil (FU)/Leucovorin (LV) in patients with advanced gastric adenocarcinoma who have prior exposure to taxane, fluoropyrimidine, and cisplatin
To determine the activity of this combination regimen.
To evaluate the treatment-related toxicities.

Detailed Description

There is presently no chemotherapy regimen considered to be the standard of care for patients with advanced gastric cancer. However, more and more patients will receive fluoropyrimidine, platinum, and taxane combination or sequential chemotherapy. Unfortunately, about half of the patients receiving chemotherapy are unresponsive and treatment results of salvage chemotherapy are unsatisfactory. For these patients, there are currently no established palliative chemotherapy options, and there is urgent need for novel, active, and less toxic regimens for patients with advanced gastric cancer failing front-line chemotherapy.

On these bases, we will investigate the activity of biweekly oxaliplatin and 5-FU/LV in patients with advanced gastric cancer who failed prior taxane, fluoropyrimidine and cisplatin chemotherapy.

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

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FOLFIRI arm	Experimental	Patients receiving FOLFIRI	Drug: oxaliplatin, 5-fluorouracil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxaliplatin, 5-fluorouracil	Drug	Oxaliplatin 85 mg/㎡ IV, day 1 over 2 hours 5-FU 400 mg/㎡ IV bolus day 1 followed by 5-fluorouracil(FU) 2,400 mg/㎡ and leucovorin (LV) 100 mg/㎡ IV continuous over 46 hours (every 2 weeks)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival		4 months

Secondary Outcomes

Measure	Description	Time Frame
Overall survival		1 year
Toxicity profile (according to National Cancer Institute Common Terminology Criteria for Adverse Event [NCI CTC AE] version 3.0)		Each cycle of chemotherapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologically proven non-resectable adenocarcinoma of stomach
Measurable disease based on Response Criteria in Solid Tumors (RECIST)
Prior chemotherapy with taxane, fluoropyrimidine, and cisplatinum in combination or sequentially, there is no time limit for the last chemotherapy
Age 18 to 70 years old
Estimated life expectancy of more than 3 months
Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
Adequate bone marrow function (white blood cell counts >4,000/µL, absolute neutrophil count [ANC]>1,500/µL, hemoglobin >9.0 g/dL, and platelets>100,000/µL),
Adequate kidney function (creatinine<1.5 mg/dL)
Adequate liver function (bilirubin<1.5 mg/dL , transaminases levels<3 times the upper normal limit [5 times for patients with liver metastasis], and serum albumin of >2.5 mg/dL)

Exclusion Criteria:

Other tumor type than adenocarcinoma
Presence or history of central nervous system metastasis
Obvious or impending bowel obstruction (including obvious peritoneal carcinomatosis)
Evidence of active gastrointestinal bleeding
Other serious illness or medical conditions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Asan medical center		Seoul		138-736	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D000077150	Oxaliplatin
D005472	Fluorouracil

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D014498	Uracil
D011744	Pyrimidinones

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