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

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ClinicalTrials.gov Identifier: NCT02558959
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Weijia Fang, Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Biliary Tract Neoplasms Drug: Irinotecan Drug: Capecitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : December 31, 2017


Arm Intervention/treatment
Experimental: Irinotecan and Capecitabine
irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w
Drug: Irinotecan
Drug: Capecitabine
Active Comparator: Irinotecan
irinotecan 180mg/m2 d1, q2w
Drug: Irinotecan



Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: within 1 year ]
    PFS


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: within 1 year ]
    OS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558959


Locations
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China, Zhejiang
First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, China, 310006
Sponsors and Collaborators
Zhejiang University

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Responsible Party: Weijia Fang, Director of Cancer Biotherapy Center, Zhejiang University
ClinicalTrials.gov Identifier: NCT02558959     History of Changes
Other Study ID Numbers: ZYYYMedOncoBIL01
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Cisplatin
Gemcitabine
Capecitabine
Irinotecan
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors