XELOX in Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy

May 17, 2019 updated by: Ho Yeong Lim, Samsung Medical Center

Phase II Study of Second Line Capecitabine Plus Oxaliplatin (XELOX) in Patients With Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

XELOX

  • Xeloda, 1000mg/㎡ bid, day 1-15, every 3 weeks
  • Oxaliplatin 130mg/㎡, day 1, every 3 weeks Until disease progression, patient's refusal or up to 8 cycles (maximum).

Study Type

Interventional

Enrollment (Anticipated)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. severe co-morbid illness or active infections
  2. pregnant or lactating women
  3. 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
  4. active CNS metastases not controllable with radiotherapy or corticosteroids
  5. known history of hypersensitivity to study drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: capecitabine+oxaliplatin
XELOX every 3 weeks
Drug: capecitabine
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
Other Names:
  • xeloda
Drug: oxaliplatin
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 12months
12months

Secondary Outcome Measures

Outcome Measure
Time Frame
response rate
Time Frame: 12months
12months
duration of response
Time Frame: 12months
12months
overall survival
Time Frame: 12months
12months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 24months
24months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 14, 2015

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

November 24, 2014

First Submitted That Met QC Criteria

January 26, 2015

First Posted (ESTIMATE)

January 30, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 20, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-09-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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