NCT00262769

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without cisplatin in treating cholangiocarcinoma or biliary tract tumors. PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine alone in treating patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

3.3 years

First QC Date

December 6, 2005

Last Update Submit

July 16, 2012

Conditions

Extrahepatic Bile Duct CancerGallbladder Cancer

Keywords

cholangiocarcinoma of the extrahepatic bile ductrecurrent extrahepatic bile duct cancerunresectable extrahepatic bile duct cancercholangiocarcinoma of the gallbladderrecurrent gallbladder cancerunresectable gallbladder cancermetastatic extrahepatic bile duct cancermetastatic gallbladder cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    From date of randomisation till date of death or last date of follow-up (up to 5 years)

    From date of randomisation till date of death or last date of follow-up (up to 5 years)

Secondary Outcomes (3)

  • Progression-free survival

    From date of randomisation till date of death or last date of follow-up (up to 5 years)

  • Quality of life

    Before and 12 weeks after completion of treatment

  • Toxicity

    During treatment and follow-up

Study Arms (2)

A - Gemcitabine

EXPERIMENTAL

Gemcitabine alone

Drug: gemcitabine hydrochloride

B - Gemcitabine and Cisplatin

EXPERIMENTAL

Gemcitabine and Cisplatin

Drug: cisplatinDrug: gemcitabine hydrochloride

Interventions

cisplatinDRUG

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

Also known as: CDDP, cis-diamminedichloroplatinum(II), cisplatinum
B - Gemcitabine and Cisplatin
gemcitabine hydrochlorideDRUG

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.

Also known as: Gemzar
A - GemcitabineB - Gemcitabine and Cisplatin

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed biliary tract, gallbladder, or ampullary carcinoma * Intra- or extra-hepatic disease allowed * Unresectable locally advanced, recurrent, or metastatic disease * No brain metastases PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL (transfusion allowed) * WBC ≥ 3,000/mm\^3 Hepatic * AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Bilirubin ≤ 1.5 times ULN * Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present) * Adequate biliary drainage * No unresolved biliary tract obstruction Renal * Creatinine \< 1.5 times ULN * Urea \< 1.5 times ULN * Glomerular filtration rate (GFR) ≥ 45 mL/min * If GFR \< 60 mL/min, isotope EDTA confirmation of adequate renal function is required Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No active, uncontrolled infection * No other severe or uncontrolled systemic disease * No other malignancy within the past 5 years except nonmetastatic basal cell or squamous cell skin cancer or carcinoma in situ of the cervix treated by cone-biopsy or resection * No psychiatric disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Chemotherapy * At least 6 months since prior adjuvant chemotherapy * No prior gemcitabine hydrochloride * No prior cisplatin * No prior systemic chemotherapy for locally advanced or metastatic disease except low-dose radiosensitizing chemotherapy in conjunction with radiotherapy Radiotherapy * Prior radiotherapy for localized disease allowed provided there is clear evidence of disease progression afterwards Surgery * Prior curative surgery allowed provided there is evidence of nonresectable disease relapse requiring systemic chemotherapy Other * Recovered from all prior therapies * Prior photodynamic therapy (PDT) allowed provided it was given for localized disease only (with no evidence of metastatic disease) and resulted in subsequent disease progression after completion of therapy OR to relieve biliary obstruction in the presence of metastatic disease * PDT must have been completed ≥ 4 weeks ago * At least 4 weeks since prior investigational agents * No other concurrent, curative anticancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (25)

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, RG24 9NA, United Kingdom

Location

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Cumberland Infirmary

Carlisle, England, CA2 7HY, United Kingdom

Location

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Princess Alexandra Hospital

Essex, England, CM20 1QX, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, England, GL1 3NN, United Kingdom

Location

Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, HU8 9HE, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Helen Rollason Cancer Care Centre at North Middlesex Hospital

London, England, N18 1QX, United Kingdom

Location

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

Hammersmith Hospital

London, England, W12 OHS, United Kingdom

Location

UCL Cancer Institute

London, England, WC1E 6DD, United Kingdom

Location

University College of London Hospitals

London, England, WIT 3AA, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

Location

Portsmouth Oncology Centre at Saint Mary's Hospital

Portsmouth Hants, England, PO3 6AD, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S10 2SJ, United Kingdom

Location

Belfast City Hospital Trust Incorporating Belvoir Park Hospital

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

Location

Related Publications (1)

  • Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.

    PMID: 20375404RESULT

MeSH Terms

Conditions

Bile Duct NeoplasmsGallbladder Neoplasms

Interventions

CisplatinGemcitabine

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • John A. Bridgewater

    University College London (UCL) Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2005

First Posted

December 7, 2005

Study Start

May 1, 2005

Primary Completion

August 1, 2008

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

GB(25)