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Cediranib Versus Placebo Plus Cisplatin/Gemcitabine Chemotherapy for Patients With Advanced Biliary Tract Cancers

NCT00939848 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2014-10-27

No results posted yet for this study

Summary

As a result of our previous NCRN study (ABC-02) cisplatin and gemcitabine (CisGem) is likely to become the international standard of care for patients with advanced biliary tract cancer (submitted: ASCO 2009).

This study, ABC-03, will determine whether the addition of cediranib(an oral Vascular Endothelial Growth Factor Receptor inhibitor) to CisGem will improve the time to disease progression in this patient group.

Conditions

  • Biliary Tract Neoplasms

Interventions

DRUG

gemcitabine

gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression

DRUG

cisplatin

cisplatin 25 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression

DRUG

Placebo

20mg od (continuous dosing) until evidence of disease progression has been confirmed

DRUG

cisplatin

cisplatin 25 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression

DRUG

cediranib

cediranib 20mg oral daily (continuous dosing)until evidence of disease progression has been confirmed

DRUG

gemcitabine

gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle for 24 weeks in the absence of disease progression

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University College, London

    lead OTHER

Principal Investigators

  • Juan Valle, MD · The Christie NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-09-30
Completion
2014-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

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 NCT00939848 on ClinicalTrials.gov