Previously untreated metastatic colorectal cancer
Conditions
Interventions
Trade Name: Avastin
Product Name: Avastin
Product Code: RO 4876646
Pharmaceutical Form: Concentrate for solution for infusion
INN or Pro
Sponsors
Australasian Gastro-Intestinal Trials Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Histological diagnosis of colorectal cancer b) Metastatic disease that is not resectable c) Age > 18 years d) Any patient in whom the investigator considers capecitabine monotherapy appropriate e) Measurable and/or non-measurable disease as assessed by CT scan f) ECOG performance status 0, 1 or 2. Patients with PS2 should have serum albumin >30 g/L g) No prior chemotherapy except for adjuvant chemotherapy given in association with (i) complete resection of primary colon or rectal cancer provided there is no clinical, radiological or biochemical evidence of relapse for at least 6 months after completion of adjuvant treatment and/or (ii) complete resection of limited colorectal metastases to liver and/or lung provided there is no clinical, radiological or biochemical evidence of relapse for at least 6 months after completion of adjuvant treatment h) Adequate bone marrow function with platelets > 100 X 109/l; neutrophils > 1.5 X 109/l i) Adequate renal function, with calculated creatinine clearance >30 ml/min (Cockcroft and Gault). For patients with creatinine clearance 2 years previously without evidence of relapse n) Women and partners of women of childbearing potential must agree to use adequate contraception o) Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Medical or psychiatric conditions that compromise the patient’s ability to give informed consent or to complete the protocol b) Patients with a lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes. c) Uncontrolled hypertension d) Active bleeding disorders within the last 3 months e) Patients on full anticoagulation with warfarin. (Patients who require full anticoagulation and who wish to participate in the study should be converted to low molecular weight heparin). (Note: patients receiving full anticoagulation with low molecular weight heparin should have no evidence of tumour invading or abutting major blood vessels on any prior CT scan) f) Participation in any investigational drug study within the previous 8 weeks g) Patients with uncontrolled clinically significant cardiac disease, arrhythmias or angina pectoris h) Patients with a history of acute myocardial infarction or cerebrovascular accident within the last 12 months i) Regular use of aspirin (>325mg/day) or NSAIDs (low dose aspirin ( 2g/ 24 hours ( performed if urine dipstick > 1+ ) n) Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Phase II stage Primary Endpoint: Treatment-related toxicity Phase III stage Primary endpoint: Progression free survival (PFS) ; Main Objective: Phase II stage Primary Objective: • To determine the relative toxicity of the combination of capecitabine and bevacizumab and the combination of capecitabine, mitomycin C (MMC) and bevacizumab with that of capecitabine monotherapy. Phase III stage Primary Objective: • To compare progression-free survival (PFS) on the three arms ; Secondary Objective: Phase II stage Secondary Objective: • To assess tumour response rate (RECIST criteria) for each arm Phase III stage Secondary Objectives: • To determine treatment related toxicity. • To determine tumour response rates ( RECIST criteria) • To determine overall survival for each treatment arm. • To compare disease related symptoms and Quality of life. • To determine cost effectiveness of bevacizumab containing treatments. | — |
Countries
United Kingdom
Outcome results
None listed