NCT02350686

Brief Summary

Phase II study of second line capecitabine plus oxaliplatin (XELOX) in patients with advanced biliary tract carcinoma after failure of gemcitabine-based chemotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
67

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 14, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

4.6 years

First QC Date

November 24, 2014

Last Update Submit

May 17, 2019

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    12months

Secondary Outcomes (4)

  • response rate

    12months

  • duration of response

    12months

  • overall survival

    12months

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    24months

Study Arms (1)

capecitabine+oxaliplatin

EXPERIMENTAL

XELOX every 3 weeks

Drug: capecitabineDrug: oxaliplatin

Interventions

capecitabineDRUG

XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles

Also known as: xeloda
capecitabine+oxaliplatin
oxaliplatinDRUG

XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles

capecitabine+oxaliplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18
  • histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer and ampulla of Vater cancer)
  • unresectable or metastatic
  • progression after treatment with first line gemcitabine-based chemotherapy
  • ECOG performance status of 0\~2
  • measurable or evaluable lesion per RECIST 1.1 criteria
  • adequate marrow, hepatic, renal and cardiac functions

You may not qualify if:

  • severe co-morbid illness or active infections
  • pregnant or lactating women
  • History of documented congestive heart failure, angina pectoris requiring medication, evidence of tranasmural myocardial infarction on ECG, poorly controlled hypertension, clinically significant valvular heart disease or high risk of uncontrollable arrhythmia
  • active CNS metastases not controllable with radiotherapy or corticosteroids
  • known history of hypersensitivity to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

CapecitabineOxaliplatin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic Chemicals

Central Study Contacts

hoyeong lim, MD,Ph

CONTACT

hoy.lim@samsung.com

sungju park

CONTACT

sungju6820.park@samsung.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Division of Hematology-Oncology, Department of Medicine

Study Record Dates

First Submitted

November 24, 2014

First Posted

January 30, 2015

Study Start

May 14, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

May 20, 2019

Record last verified: 2019-05

Locations

KR(1)