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Second Line Therapy in Advanced Biliary Tract Cancer

NCT01530503 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2016-02-25

No results posted yet for this study

Summary

The purpose of this study is to assess the therapeutic activity of capecitabine alone or in combination with mitomycin C as second-line therapy in patients with advanced/metastatic biliary adenocarcinoma in progression after gemcitabine and platinum compounds

Conditions

  • Biliary Tract Cancer

Interventions

DRUG

capecitabine and mitomycin

oral capecitabine 2000 mg/m2 day 1-14 in two divided doses taken with food plus bolus IV infusion mitomycin C 6 mg/m2 day 1. Cycles will be repeated in both arms every 3 weeks till progression, unacceptable toxicity, medical decision or patient's refusal or for a maximum of 6 months

DRUG

Capecitabine

oral capecitabine 2000 mg/m2 day 1-14 in two divided doses taken with food. Cycles will be repeated in both arms every 3 weeks till progression, unacceptable toxicity, medical decision or patient's refusal or for a maximum of 6 months

Sponsors & Collaborators

  • Regione Lombardia

    collaborator OTHER

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • stefano cereda, MD · Ospedale San Raffaele (Milan, Italy)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01530503 on ClinicalTrials.gov