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

• Sponsor: Zhejiang University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02558959
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Actual Duration (Months): 28
• Patients Per Site Per Month: 2.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Tract Neoplasms	Drug: Irinotecan; Drug: Capecitabine	Phase 2

Study Design

• Study Type: Interventional
• 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: Sep 1, 2015
• Actual Primary Completion Date: Sep 30, 2017
• Actual Study Completion Date: Dec 31, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival [within 1 year]

   PFS

Secondary Outcome Measures

1. Overall Survival [within 1 year]

   OS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First affiliated hospital, Zhejiang University	Hangzhou	Zhejiang	China	310006

Sponsors and Collaborators

• Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weijia Fang, Director of Cancer Biotherapy Center, Zhejiang University
• ClinicalTrials.gov Identifier: NCT02558959
• Other Study ID Numbers: ZYYYMedOncoBIL01
• First Posted: Sep 24, 2015
• Last Update Posted: Feb 13, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Biliary Tract Neoplasms; Capecitabine; Irinotecan

Study Results

No Results Posted as of Feb 13, 2018