Condition category
Cancer
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
16/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cancer of the biliary tract (gallbladder and bile duct) is a relatively rare form of cancer. The gall bladder is a small pouch which stores bile (a liquid essential for the breakdown of fats in the diet) made by the liver. Cancer of the gall bladder or bile duct that has spread and cannot be removed by an operation (inoperable) is often treated with chemotherapy. The aim of this study is to find out how effective a combination of two drugs, called capecitabine and oxaliplatin, is in treating these cancers as measured by shrinking the tumour on a CT scan. The study will also try to find out what side-effects are experienced by patients with these cancers when treated with this chemotherapy regimen.

Who can participate?
Adults with inoperable cancer of the gall bladder or bile duct.

What does the study involve?
Patients receive up to 6 cycles of chemotherapy. One cycle consists of capecitabine tablets given by mouth twice a day for 14 days. The oxaliplatin is given as a drip into a vein over 2 hours on the first day. This cycle of treatment is repeated every 3 weeks. A CT scan will be performed before starting treatment and then after 3 and 6 cycles of treatment to see what effect there has been on the size of the tumour.

What are the possible benefits and risks of participating?
There is a possibility that the treatment used in this study could help to shrink the tumour, however this is not certain. There is a risk that participants will experience side effects from the chemotherapy, including hair loss, sickness and vomiting, pain, tingling and numbness in the hands and feet, skin rash, blisters and peeling of the skin on the hands and feet, increased risk of infections which may be serious, or bruising.

Where is the study run from?
Five hospitals in Scotland, Ireland and the North of England (UK)

When is the study starting and how long is it expected to run for?
July 2003 to January 2006

Who is funding the study?
North Glasgow University Hospitals NHS Division (UK)

Who is the main contact?
Ms Eileen Soulis
eileen.soulis@glasgow.ac.uk

Trial website

http://www.west-cancer-trials.org/reports/rwservlet?public_study_desc+studyno=GI85

Contact information

Type

Scientific

Primary contact

Ms Eileen Soulis

ORCID ID

Contact details

Clinical Trial Co-ordinator
Cancer Research UK Clinical Trials Unit
(partner in CaCTUS - Cancer Clinical Trials Unit Scotland)
Beatson West of Scotland Cancer Centre
Level 0
1053 Gt. Western Road
Glasgow
G12 0YN
United Kingdom
+44 (0) 141 301 7223
eileen.soulis@glasgow.ac.uk

Additional identifiers

EudraCT number

2004-000928-32

ClinicalTrials.gov number

Protocol/serial number

1744

Study information

Scientific title

A phase II study of capecitabine and oxaliplatin combination chemotherapy in patients with inoperable adenocarcinoma of the gall bladder or biliary tract

Acronym

BILXELOX (GI85)

Study hypothesis

The primary objective as stated in the study protocol is to determine the objective response rate (complete or partial), by the response evaluation criteria in solid tumours (RECIST) criteria, of capecitabine and oxaliplatin combination chemotherapy in patients with inoperable adenocarcinoma of the gall bladder or biliary tract.

Using an optimal two-stage Simon design, a total of 43 patients gives 80% power at the 5% significance level to detect a response rate of greater than or equal to 40%, at which point it would be appropriate to consider further studies with this regimen, from a response rate of 20%, below which this regimen would not be pursued in subsequent studies.

Ethics approval

West of Scotland REC 1, 15/05/2003, ref: MREC 03/8/027

Study design

Non-randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Biliary Tract, Gall Bladder

Intervention

1. Capecitabine, twice daily (BID) for 14 days every 21 days, 1000 mg/m^2
2. Oxaliplatin, once daily (OD) once every 21 days, 130 mg/m^2

Duration of treatment was 18 weeks (maximum of 6 cycles), duration of follow-up was until death or progression, or at the investigator's discretion.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Objective response rate (complete and partial) by RECIST of capecitabine and oxaliplatin combination, assessed after 13 patients recruited.

Secondary outcome measures

Measured after 43 patients are recruited:
1. Toxicity
2. Progression-free survival
3. Overall survival

Overall trial start date

10/07/2003

Overall trial end date

20/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically or cytologically proven adenocarcinoma of the gall bladder or biliary tract
2. Inoperable disease as determined by radiological assessment, laparotomy or laparoscopy
3. At least one site of unidimensional measurable disease. Lesions must be at least 10 mm in diameter if measured on a spiral computed tomography (CT) scan.
4. Performance status greater than or equal to 2 (Eastern Cooperative Oncology Group [ECOG])
5. Adequate renal function (serum creatinine less than 1.5 x the upper limit of the normal reference range) and creatinine clearance greater than 50 ml/min as calculated by the Cockroft-Gault formula. Patients with creatinine clearance less than or equal to 50 mL/min by the Cockroft-Gault formula are eligible if the creatinine clearance is greater than 50 mL/min if measured by an EDTA assessment.
6. Written informed consent
7. Aged greater than 18 years, either sex
8. No prior chemotherapy for advanced disease
9. Able to reliably tolerate and comply with oral medication (capecitabine)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 43

Participant exclusion criteria

1. Any evidence of uncontrolled cardiac disease or any other serious medical or psychiatric disorder that would be a contra-indication for prescribing this chemotherapy regimen
2. Pregnancy. Women of child-bearing potential not taking adequate contraception, and women who are breast feeding will also be excluded.
3. No prior or concurrent malignancy other than basal cell carcinoma of the skin or in situ neoplasia of the cervix uteri
4. Inadequate haematological function as defined by:
4.1. Haemoglobin (Hb) less than 10 g/dl
4.2. Neutrophil count less than 1.5 x 10^9/l
4.3. Platelets less than 100 x 10^9/l
5. Deranged liver function tests: serum bilirubin greater than 2.5 x upper limit of normal reference range for laboratory; transaminases greater than 5 x upper limit of normal reference range
6. Life expectancy less than 3 months
7. Any chemotherapy, radiotherapy, hormonal or immunotherapy within the last 4 weeks
8. Patients with a lack of physical integrity of the gastrointestinal (GI) tract leading to a malabsorption syndrome or intestinal obstruction that would impair administration or absorption of oral therapy
9. Patients with greater than grade 1 peripheral sensory neuropathy
10. Patients with known sensitivity to fluoropyrimidines or oxaliplatin

Recruitment start date

10/07/2003

Recruitment end date

20/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Beatson West of Scotland Cancer Centre
Cancer Research UK Clinical Trials Unit (partner in CaCTUS - Cancer Clinical Trials Unit Scotland) Level 0 1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Trial participating centre

St James Hospital
James's St
Dublin
8
Ireland

Trial participating centre

Ninewells Hospital
Dundee
DD2 1UB
United Kingdom

Trial participating centre

Western General Hospital
Crewe Road South
Edinburgh
EH4 2XU
United Kingdom

Trial participating centre

Newcastle General Hospital
Westgate Road
Newcastle upon Tyne
NE4 6BE
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde

Sponsor details

Research and Development Central Office
Tennent Institute
38 Church Street
Glasgow
G11 6NT
United Kingdom

Sponsor type

Government

Website

http://www.ngt.org.uk/research/home.htm

Funders

Funder type

Government

Funder name

North Glasgow University Hospitals NHS Division (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Presentation (published abstract) at an international meeting
2. Planned publication in BMC Research Notes

Intention to publish date

30/06/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/03/2016: Plain English summary and publication and dissemination plan have been added. The trial participating centres have also been updated to include St James Hospital, Dublin; Ninewells Hospital, Dundee; Western General Hospital, Edinburgh; Newcastle General Hospital. 04/03/2016: No publications found, verifying study status with principal investigator.