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Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer

Primary Purpose

Biliary Tract Neoplasms

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Irinotecan
Capecitabine
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with histologically confirmed advanced biliary tract cancer who had experienced progression during first-line gemcitabine and cisplatin
  • Age 18 years or older
  • Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
  • Karnofsky performance status (KPS) of at least 70%
  • Adequate renal function, adequate hepatic function, adequate bone marrow function

Exclusion Criteria:

  • The presence of any severe concomitant disease that could interrupt the planned treatment
  • Intractable pain
  • Hypersensitivity to study drugs
  • Serious cardiovascular disease
  • If female, pregnancy or breastfeeding

Sites / Locations

  • First affiliated hospital, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Irinotecan and Capecitabine

Irinotecan

Arm Description

irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w

irinotecan 180mg/m2 d1, q2w

Outcomes

Primary Outcome Measures

Progression Free Survival
PFS

Secondary Outcome Measures

Overall Survival
OS

Full Information

First Posted
September 21, 2015
Last Updated
February 10, 2018
Sponsor
Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT02558959
Brief Title
Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer
Official Title
Effect of Second-line Irinotecan and Capecitabine Versus Irinotecan Alone in Advanced Biliary Tract Cancer Patients Progressed After First-line Gemcitabine and Cisplatin: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University

4. Oversight

5. Study Description

Brief Summary
This study is designed to investigate the effect of second-line irinotecan and capecitabine versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract cancer patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irinotecan and Capecitabine
Arm Type
Experimental
Arm Description
irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w
Arm Title
Irinotecan
Arm Type
Active Comparator
Arm Description
irinotecan 180mg/m2 d1, q2w
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
PFS
Time Frame
within 1 year
Secondary Outcome Measure Information:
Title
Overall Survival
Description
OS
Time Frame
within 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histologically confirmed advanced biliary tract cancer who had experienced progression during first-line gemcitabine and cisplatin Age 18 years or older Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI) Karnofsky performance status (KPS) of at least 70% Adequate renal function, adequate hepatic function, adequate bone marrow function Exclusion Criteria: The presence of any severe concomitant disease that could interrupt the planned treatment Intractable pain Hypersensitivity to study drugs Serious cardiovascular disease If female, pregnancy or breastfeeding
Facility Information:
Facility Name
First affiliated hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China

12. IPD Sharing Statement

Learn more about this trial

Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer

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