Salvage mFOLFOX in BTC After Failure of Gemcitabine | NCT01127555

Studies
Salvage mFOLFOX in BTC After Failure of Gemcitabine

NCT01127555

Sponsor

Chung-Ang University

Status

Completed

Last Update Posted

Oct 8, 2013Estimated

Enrollment

30Actual

Phase

Phase 2

Conditions

Unresectable Biliary Tract Cancer

Interventions

5-fluorouracil, leucovorin, oxaliplatin

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

Oct 2013

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

Apr 2010

Primary Completion Date

Jun 2012Actual

Completion Date

Jan 2013Actual

First Submitted Date

May 5, 2010

First Submission Date that Met QC Criteria

May 20, 2010

First Posted Date

May 21, 2010Estimated

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

Oct 6, 2013

Last Update Posted Date

Oct 8, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

In Gyu Hwang, Chung-Ang University Hospital, Chung-Ang UniversityPrincipal Investigator

Lead Sponsor

Chung-Ang UniversityOTHER

Collaborators

Name	Class
Gyeongsang National University Hospital	OTHER
Dong-A University Hospital	OTHER
Samsung Medical Center	OTHER

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 evaluate the efficacy and safety of mFOLFOX (5-fluorouracil, leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer who had failed gemcitabine.

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

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
5-fluorouracil, leucovorin, oxaliplatin	Drug	D1 Oxaliplatin 85mg/m2 D1, 2 LV 30mg/m2 IV push D1, 2 5-FU 1500mg/m2 CIV over 24hrs Every 2 weeks		mFOLFOX

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response rate	Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan	1 year

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the safety	Clinically assessed every cycle (2weeks)	1 year
To estimate the time to progression		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age : older than 18
Histologically confirmed adenocarcinoma of the biliary tract
Metastatic or unresectable biliary cancer
Prior exposure to gemcitabine chemotherapy for biliary cancer
Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral Computed Tomography (CT) or multidetector CT
Adequate bone marrow, liver, renal function

Exclusion Criteria:

Pregnancy and breast-feeding.
Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
Symptomatic or uncontrolled brain metastasis

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
In Gyu Hwang, M.D.	Chung-Ang University Yongsan Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chung-Ang University Yongsan Hospital		Yongsan	Seoul	140-757	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001661	Biliary Tract Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001660	Biliary Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005472	Fluorouracil
D002955	Leucovorin
D000077150	Oxaliplatin

Ancestor Terms

ID	Term
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided