Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	16 and over	Other	CRUK-ABC-02 EU-205103, ISRCTN82956140, EUDRACT-2004-004882-14, CTA-21266/0005/001, NCT00262769

Objectives

Primary

1. 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

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

Entry Criteria

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

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

Patient Characteristics:

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL (transfusion allowed)
• WBC ≥ 3,000/mm³

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

Expected Enrollment

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

Outcomes

Survival up to 5 years

Progression-free survival
Quality of life as measured by EORTC Quality of Life Questionnaire Core 30 Items periodically
Toxicity as measured by NCI CTC periodically

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

Trial Contact Information

Trial Lead Organizations

UCL Cancer Institute

John Bridgewater, Protocol chair		Ph: 44-20-7679-9326 Email: j.bridgewater@ucl.ac.uk

United Kingdom
England
	Basingstoke
	Basingstoke and North Hampshire NHS Foundation Trust
		Contact Person	Ph:  44-125-631-4793
	Birmingham
	Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
		Daniel Palmer, MD	Ph:  44-121-472-1311
	Cambridge
	Addenbrooke's Hospital
		Charles Wilson, MD	Ph:  44-1223-217-110
			Email: charles.wilson@addenbrookes.nhs.uk
	Carlisle
	Cumberland Infirmary
		Jonathan Nicoll, MD	Ph:  44-122-881-4688
			Email: jonathan.nicoll@ncumbria-acute.nhs.uk
	Cheltenham
	Gloucestershire Oncology Centre at Cheltenham General Hospital
		Sean Elyan, MD	Ph:  44-1242-22-2222
			Email: sean.elyan@egnhst.org.uk
	Derby
	Derbyshire Royal Infirmary
		R. B. Kulkarni, MD	Ph:  01332-347141 ext. 4562
	Essex
	Princess Alexandra Hospital
		John Bridgewater	Ph:  44-1279-827-423
			Email: j.bridgewater@ucl.ac.uk
	Gloucester
	Gloucestershire Royal Hospital
		Sean Elyan, MD	Ph:  44-8454-222-222
	Hull
	Princess Royal Hospital at Hull and East Yorkshire NHS Trust
		Anthony Maraveyas	Ph:  44-148-467-6703
	Leeds
	Leeds Cancer Centre at St. James's University Hospital
		D. Allan Anthoney, MD	Ph:  44-113-267-3411
			Email: danthoney@nhs.net
	London
	Hammersmith Hospital
		Harpreet Wasan	Ph:  44-208-383-3057
			Email: wasan@cancer.org.uk
	Helen Rollason Cancer Care Centre at North Middlesex Hospital
		John Bridgewater	Ph:  44-20-8887-2687
			Email: j.bridgewater@ucl.ac.uk
	Royal Marsden - London
		Contact Person	Ph:  44-20-7352-8171
	UCL Cancer Institute
		Contact Person	Ph:  44-20-7679-6697
	University College of London Hospitals
		Contact Person	Ph:  44-20-7636-8333
	Maidstone
	Maidstone Hospital
		Justin Waters, MD	Ph:  44-162-222-5149
	Merseyside
	Clatterbridge Centre for Oncology
		Sun Myint, MD, FRCP(Edin), DMRT, FFRCS, FRCP	Ph:  44-151-334-1155
			Email: sun.myint@ccotrust.nhs.uk
	Northwood
	Mount Vernon Cancer Centre at Mount Vernon Hospital
		M. Harrison, MD	Ph:  44-1923-826-111
	Nottingham
	Nottingham City Hospital NHS Trust
		Srinivasan Madhusudan, MD	Ph:  44-115-823-1850
			Email: srinivasan.madhusudan@nottingham.ac.uk
	Portsmouth Hants
	Portsmouth Oncology Centre at Saint Mary's Hospital
		Contact Person	Ph:  44-23-9228-6000
	Sheffield
	Cancer Research Centre at Weston Park Hospital
		Jonathan Wadsley	Ph:  44-114-226-5000
Northern Ireland
	Belfast
	Belfast City Hospital Trust Incorporating Belvoir Park Hospital
		Martin Eatock, MD	Ph:  44-28-9032-9241
Scotland
	Aberdeen
	Aberdeen Royal Infirmary
		Marianne Nicolson, MD	Ph:  44-0845-456-6000
Wales
	Cardiff
	Velindre Cancer Center at Velindre Hospital
		Contact Person	Ph:  44-29-2031-6292
	Rhyl, Denbighshire
	Glan Clwyd Hospital
		Angel Garcia-Alonso, MD	Ph:  44-1745-583-910

Registry Information
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
Trial Start Date		2005-05-12
Trial Completion Date		2008-08-12 (estimated)
Registered in ClinicalTrials.gov		NCT00262769
Date Submitted to PDQ		2005-09-30
Information Last Verified		2008-12-21

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