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

Phase 4

Completed

Conditions: Advanced colorectal cancer
Cancer
Colorectal cancer

Registration Number: ISRCTN41540878

Lead Sponsor: Cancer Trials New Zealand (CTNZ)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

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

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