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Extrahepatic Bile Duct CancerPhase 3ABC-02NCT00262769

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

A Phase 3 study testing cisplatin and gemcitabine hydrochloride in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by University College, London at 25 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
cisplatin and gemcitabine hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
324 participants
Where
25 sitesUnited Kingdom
Study dates
May 2005to Aug 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United Kingdom25 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Basingstoke and North Hampshire NHS Foundation Trust

    Basingstoke, England, RG24 9NA

  • Belfast City Hospital Trust Incorporating Belvoir Park Hospital

    Belfast, Northern Ireland, BT9 7AB

  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

    Birmingham, England, B15 2TH

  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF14 2TL

  • Cumberland Infirmary

    Carlisle, England, CA2 7HY

  • Gloucestershire Oncology Centre at Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

  • Derbyshire Royal Infirmary

    Derby, England, DE1 2QY

  • Princess Alexandra Hospital

    Essex, England, CM20 1QX

  • Gloucestershire Royal Hospital

    Gloucester, England, GL1 3NN

  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust

    Hull, England, HU8 9HE

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

    Leeds, England, LS9 7TF

  • Helen Rollason Cancer Care Centre at North Middlesex Hospital

    London, England, N18 1QX

  • Royal Marsden - London

    London, England, SW3 6JJ

  • Hammersmith Hospital

    London, England, W12 OHS

  • UCL Cancer Institute

    London, England, WC1E 6DD

  • University College of London Hospitals

    London, England, WIT 3AA

  • Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • Clatterbridge Centre for Oncology

    Merseyside, England, CH63 4JY

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Nottingham City Hospital

    Nottingham, England, NG5 1PB

  • Portsmouth Oncology Centre at Saint Mary's Hospital

    Portsmouth Hants, England, PO3 6AD

  • Glan Clwyd Hospital

    Rhyl, Denbighshire, Wales, LL 18 5UJ

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S10 2SJ

Other trials in United Kingdom

About this study

Official title: Gemcitabine, Alone or in Combination With Cisplatin, in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumors: A Multicentre, Randomized Phase III Study

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.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the overall survival of patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors treated with gemcitabine hydrochloride with vs without cisplatin.

Secondary

  • Compare the progression-free survival of patients treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.
  • Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, primary site of disease (gallbladder vs bile ducts vs ampulla), prior therapy (photodynamic therapy [PDT] vs non-PDT therapy vs none), ECOG performance status (0 vs 1 vs 2), and disease status (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 1½ hours on days 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, 12 weeks, and after finishing treatment.

After completion of study treatment, patients are followed periodically for at least 3 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Keywords
cholangiocarcinoma of the extrahepatic bile duct, recurrent extrahepatic bile duct cancer, unresectable extrahepatic bile duct cancer, cholangiocarcinoma of the gallbladder, recurrent gallbladder cancer, unresectable gallbladder cancer, metastatic extrahepatic bile duct cancer, metastatic gallbladder cancer
Medical subject headings
Bile Duct Neoplasms, Gallbladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cisplatinDrug

    Also called CDDP, cis-diamminedichloroplatinum(II), cisplatinum

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

  • gemcitabine hydrochlorideDrug

    Also called Gemzar

    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.

Study groups in NCT00262769
Study groupRoleWhat they receive
A - GemcitabineExperimentalGemcitabine alone
Receives: Drug: gemcitabine hydrochloride
B - Gemcitabine and CisplatinExperimentalGemcitabine and Cisplatin
Receives: Drug: cisplatin; Drug: gemcitabine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

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

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

Secondary outcomes (3)

  1. Progression-free survival

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

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

  2. Quality of life

    Quality of life as measured by EORTC Quality of Life Questionnaire Core 30 Items periodically

    Measured: Before and 12 weeks after completion of treatment

  3. Toxicity

    Toxicity as measured by NCI CTC periodically. The proportion of patients who experience a toxicity of grade 3 or 4 will be compared between the two arms of the trial.

    Measured: During treatment and follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionAug 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00262769
Sponsor's protocol ID
CDR0000455013
Other IDs
CRUK-ABC-02, EU-205103, ISRCTN82956140, EUDRACT-2004-004882-14, CTA-21266/0005/001
Acronym
ABC-02
Status last verified
Jul 2012
First submitted
6 Dec 2005
Last updated
17 Jul 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20375404

  • Lamarca A, Ross P, Wasan HS, Hubner RA, McNamara MG, Lopes A, Palmer DH, Valle JW, Bridgewater J. Advanced extrahepatic cholangiocarcinoma and gallbladder cancer: Post-hoc analysis of the ABC-01, -02 and -03 clinical trials. JHEP Rep. 2026 Jul;8(7):101833. doi: 10.1016/j.jhepr.2026.101833. Epub 2026 Mar 24.

    PubMed 41887529

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin and gemcitabine hydrochloride in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by University College, London at 25 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From date of randomisation till date of death or last date of follow-up (up to 5 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00262769, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2012.

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