Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility 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

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 Contact Information

Trial Lead Organizations/Sponsors

UCL Cancer Institute

John A. Bridgewater

Study Chair

United Kingdom
	Belfast
	Belfast City Hospital Trust Incorporating Belvoir Park Hospital
		Martin Eatock, MD	Ph: 44-28-9032-9241
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: 44-121-414-3291
			Email: d.palmer@bham.ac.uk
	Cambridge
	Addenbrooke's Hospital
		Charles B. Wilson, MD	Ph: 44-1223-217-110
			Email: charles.wilson@addenbrookes.nhs.uk
	Carlisle
	Cumberland Infirmary
		Jonathan J. 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 A. 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 S. Wasan	Ph: 44-208-383-3057
			Email: wasan@cancer.org.uk
	Helen Rollason Cancer Care Centre at North Middlesex Hospital
		John A. 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, F	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
		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
Scotland
	Aberdeen
	Aberdeen Royal Infirmary
		Marianne C. 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

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00262769
Information obtained from ClinicalTrials.gov on April 25, 2012

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