Condition category
Cancer
Date applied
01/05/2006
Date assigned
15/05/2006
Last edited
02/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ctnz.auckland.ac.nz

Contact information

Type

Scientific

Primary contact

Prof Michael Findlay

ORCID ID

Contact details

Cancer Trials New Zealand (CTNZ)
Rm 3443 Building 503
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland
1003
New Zealand
+64 (0)9 373 7599 ext 82005
mp.findlay@auckland.ac.nz

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTNZ _05_6

Study information

Scientific title

A multicentre study using the chemotherapy combination of bi-monthly Xeloda and Eloxatin, with the addition of Avastin, in patients with advanced colorectal cancer

Acronym

XEN study

Study hypothesis

Bi-monthly dose intensified capecitabine (Xeloda) and oxaliplatin (Eloxatin) with concurrent bevacizumab (Avastin) will be a tolerable, effective, drug combination in the treatment of advanced colorectal cancer.

Ethics approval

New Zealand Multi-Regional Ethics Committee, 20/04/2006, ref: MEC/06/04/041

Study design

Multi-centre phase IV study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Advanced colorectal cancer

Intervention

Dose intensified capecitabine days 1-7, oxaliplatin IV day 1 (diCapeOx), repeat every 14 days plus concurrent bevacizumab IV day 1, repeat every 14 days. Treatment will continue until progression, unacceptable toxicity or patient request.

Intervention type

Drug

Phase

Phase IV

Drug names

Capecitabine (Xeloda), oxaliplatin (Eloxatin), bevacizumab (Avastin)

Primary outcome measures

Progression free survival

Secondary outcome measures

1. Proportion of patients who receive at least 75% of the planned dose
2. Rate of grade 3 and 4 neutropenia
3. Grade 3 and 4 toxicity rates
4. Tumour response rates
5. Survival

Overall trial start date

26/05/2006

Overall trial end date

31/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histological/cytological confirmation of colorectal cancer
2. Locally recurrent or metastatic disease
3. Patient performance status (Eastern Cooperative Oncology Group (ECOG) 0-1
4. Creatinine clearance greater than or equal to 50 ml/min assessed by Cockroft-Gault formula. If Cockroft-Gault formula yields less than 50 ml/min, direct measurement of creatinine clearance or glomerular filtration rate may be made according to local practice. Direct measurement must be greater than 50 ml/min.
5. Urine dipstick of proteinuria <2+. Patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate ≤1 g of protein per 24 hr

6. Laboratory values as follows:
Haematology:
a. Absolute neutrophil count (ANC) >1.5 x 10^9 /l
b. Platelet count >100 x 10^9 /l
c. Haemoglobin >9 g/dl (may be transfused to maintain or exceed this level)
d. International normalized ratio (INR) <1.5; arterial pulse propagation time (APPT) <1.5 x upper limit of normal (ULN)
Biochemistry:
a. Total bilirubin <1.5 x ULN; serum total bilirubin <30 μmol/l
b. Aspartate aminotransferase (AST) or alanine transaminase (ALT) <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases
c. Serum creatinine <2.0 mg/dl or 177 µmol/l (see creatinine clearance criteria above)
7. Age ≥18years
8. Accessible for treatment and follow up
9. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Previous systemic therapy (excluding adjuvant treatment) for advanced colorectal cancer
2. Less than six months following last dose of adjuvant systemic therapy
3. Current or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational drug study
4. Unsuitable for treatment with capecitabine (e.g. fluorouracil [5FU] side effects suggestive of dihydropyrimidine dehydrogenase deficiency; gastrointestinal [GI] disease precluding oral therapy)
5. Serious uncontrolled infection
6. Unsuitable for treatment with oxaliplatin (e.g. significant neuropathy i.e. greater than grade 1 Common Toxicity Criteria [CTC] criteria)
7. Brain and/or leptomeningeal disease
8. Pregnant or breastfeeding women
9. Concurrent anticancer therapy (any radiation must be completed at least four weeks before registration)
10. Other malignancy in previous five years except adequately treated basal cell or squamous cell carcinoma of skin or in-situ carcinoma of the cervix
11. Treatment with antiviral agent sorivudine, or related compounds such as brivudine
12. Clinically significant and active cerebral vascular disease and/or cerebral vascular accident ≤6 months prior to registration, myocardial infarction ≤1 year prior to registration, uncontrollable hypertension whilst receiving chronic medication, unstable angina, New York Heart Association (NYHA) grade 2 or greater congestive heart failure or serious cardiac arrythmia requiring medication
13. Major surgery within 28 days prior to treatment commencement or anticipation of the need for major surgical procedure during the course of the study
14. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants for therapeutic purposes
15. Chronic daily treatment with aspirin (>325 mg/day)
16. Serious, non-healing wound, ulcer, or bone fracture
17. Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
18. Patients with known allergy to Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies or to any excipients of bevacizumab formulation or to any other study drugs
19. Patients unable to swallow oral tablets

Recruitment start date

26/05/2006

Recruitment end date

31/03/2009

Locations

Countries of recruitment

New Zealand

Trial participating centre

Cancer Trials New Zealand (CTNZ)
Auckland
1003
New Zealand

Sponsor information

Organisation

Cancer Trials New Zealand (CTNZ)

Sponsor details

Room 3443 Building 503
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland
1003
New Zealand
+64 (0)9 373 7599 ext 83585
greta.riley@auckland.ac.nz

Sponsor type

Research organisation

Website

http://www.ctnz.auckland.ac.nz

Funders

Funder type

Industry

Funder name

Research grant from Roche Products (NZ) Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25274181

Publication citations

Additional files

Editorial Notes