A multicentre study using the chemotherapy combination of bi-monthly Xeloda and Eloxatin, with the addition of Avastin, in patients with advanced colorectal cancer
| ISRCTN | ISRCTN41540878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41540878 |
| Secondary identifying numbers | CTNZ _05_6 |
- Submission date
- 01/05/2006
- Registration date
- 15/05/2006
- Last edited
- 02/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Michael Findlay
Scientific
Scientific
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
| Phone | +64 (0)9 373 7599 ext 82005 |
|---|---|
| mp.findlay@auckland.ac.nz |
Study information
| Study design | Multi-centre phase IV study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study 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(s) | New Zealand Multi-Regional Ethics Committee, 20/04/2006, ref: MEC/06/04/041 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Capecitabine (Xeloda), oxaliplatin (Eloxatin), bevacizumab (Avastin) |
| Primary outcome measure | 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 study start date | 26/05/2006 |
| Overall study end date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| 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 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
Study participating centre
Cancer Trials New Zealand (CTNZ)
Auckland
1003
New Zealand
1003
New Zealand
Sponsor information
Cancer Trials New Zealand (CTNZ)
Research organisation
Research organisation
Room 3443 Building 503
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland
1003
New Zealand
| Phone | +64 (0)9 373 7599 ext 83585 |
|---|---|
| greta.riley@auckland.ac.nz | |
| Website | http://www.ctnz.auckland.ac.nz |
Funders
Funder type
Industry
Research grant from Roche Products (NZ) Ltd
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/10/2014 | Yes | No |
