Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors

PHASE3CompletedINTERVENTIONAL
Enrollment

324

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

August 31, 2008

Conditions
Extrahepatic Bile Duct CancerGallbladder Cancer
Interventions
DRUG

cisplatin

25 mg/m2 in 1000 mls 0.9% saline given over 1 hour followed by 500 mls 0.9% saline over 90 mins

DRUG

gemcitabine hydrochloride

1000mg/m2 in 250-500mls 0.9% saline over 30 mins by intravenous infusions on day 1, 8 and 15 (Arm A only) of each 28 (Arm A) or 21 (Arm B) day cycle.

Trial Locations (25)

RG24 9NA

Basingstoke and North Hampshire NHS Foundation Trust, Basingstoke

B15 2TH

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust, Birmingham

CB2 2QQ

Addenbrooke's Hospital, Cambridge

CA2 7HY

Cumberland Infirmary, Carlisle

GL53 7AN

Gloucestershire Oncology Centre at Cheltenham General Hospital, Cheltenham

DE1 2QY

Derbyshire Royal Infirmary, Derby

CM20 1QX

Princess Alexandra Hospital, Essex

GL1 3NN

Gloucestershire Royal Hospital, Gloucester

HU8 9HE

Princess Royal Hospital at Hull and East Yorkshire NHS Trust, Hull

LS9 7TF

Leeds Cancer Centre at St. James's University Hospital, Leeds

N18 1QX

Helen Rollason Cancer Care Centre at North Middlesex Hospital, London

SW3 6JJ

Royal Marsden - London, London

W12 OHS

Hammersmith Hospital, London

WC1E 6DD

UCL Cancer Institute, London

WIT 3AA

University College of London Hospitals, London

ME16 9QQ

Maidstone Hospital, Maidstone

CH63 4JY

Clatterbridge Centre for Oncology, Merseyside

HA6 2RN

Mount Vernon Cancer Centre at Mount Vernon Hospital, Northwood

NG5 1PB

Nottingham City Hospital, Nottingham

PO3 6AD

Portsmouth Oncology Centre at Saint Mary's Hospital, Portsmouth Hants

S10 2SJ

Cancer Research Centre at Weston Park Hospital, Sheffield

BT9 7AB

Belfast City Hospital Trust Incorporating Belvoir Park Hospital, Belfast

AB25 2ZN

Aberdeen Royal Infirmary, Aberdeen

CF14 2TL

Velindre Cancer Center at Velindre Hospital, Cardiff

LL 18 5UJ

Glan Clwyd Hospital, Rhyl, Denbighshire

All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

University College, London

OTHER

NCT00262769 - Gemcitabine With or Without Cisplatin in Treating Patients With Unresectable Locally Advanced or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors | Biotech Hunter | Biotech Hunter