A randomised, open-label Phase III study to assess efficacy and safetyof bevacizumab in combination with capecitabine as first linetreatment for elderly patients with metastatic colorectal cancer - AVEX
- Conditions
- FIRST LINE METASTATIC COLORECTAL CARCINOMAMedDRA version: 6.1Level: PTClassification code 10052358
- Registration Number
- EUCTR2006-003293-10-IT
- Lead Sponsor
- ROCHE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 430
Written informed consent
Age >= 70 years
Histologically or cytologically confirmed carcinoma of the colon
and/or rectum
Diagnosis of metastatic disease not more than 6 months prior to enrolment
At least one measurable metastatic lesion (as per RECIST criteria)
Prior adjuvant (or neo-adjuvant for rectal cancer patients)
chemotherapy allowed if completed more than 6 months before inclusion
ECOG performance score of 0 – 2
Live expectancy > 3 month
Absolute neutrophil count (ANC) >= 1.5 × 109/L
Platelet count >= 100 x 109/L
Hemoglobin >= 9 g/dL (may be transfused to maintain or exceed
this level)
International Normalised Ratio (INR) <= 1.5 International normalized ration (INR) <= 1.5 and partial
thromboplastin time (PPT) <= 1.5 x upper limit of normal (ULN)
Total bilirubin <= 1.5 x ULN
AST and ALP <= 2.5 times ULN, 5x ULN in patients with liver metastases
Calculated creatinine clearance >=50 mL/min
Urine dipstick for proteinuria < 2+. If urine dipstick is >= 2+, 24-
hour urine must demonstrate <= 1 g of protein in 24 hours
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
Patients who received adjuvant anti-VEGF treatment
Prior chemotherapeutic treatment for metastatic CRC
Clinical evidence of brain metastases or history or evidence upon
physical examination of CNS disease unless adequately treated
Past or current history (within the last 5 years prior to treatment
start) of other malignancies except metastatic colorectal cancer
(Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible)
Clinically significant cardiovascular disease, for example CVA
(<= 6 months before treatment start), myocardial infarction (<= 6 months before treatment start), unstable angina, NYHA >= grade 2, CHF, arrhythmia requiring medication, or uncontrolled hypertension
Treatment with any other investigational agent, or participation
in another clinical trial within 30 days prior to entering this study
Known hypersensitivity to any of the study drugs
Current or recent (within 10 days of first dose of study treatment)
daily use of aspirin (> 325 mg/day) or other NSAID
Current or recent (within 10 days prior to study treatment start)
use of full-dose oral or parenteral anticoagulants or thrombolytic
agent for therapeutic (as opposed to prophylactic) purposes.
Patients receiving (or considered candidate to receive)
anticoagulants agents as prophylaxis of cardiovascular risk, should continue (or start) the appropriate treatment at study entry
History of thromboembolic or haemorrhagic events within 6 months prior to treatment
History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 6 month prior to enrolment
Evidence of bleeding diathesis or coagulopathy Serious, non healing wound, ulcer, or bone fracture
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment
Evidence of any other disease, metabolic dysfunction, physical
examination finding or laboratory finding giving reasonable
suspicion of a disease or condition that contraindicates the use of
an investigational drug or puts the patient at high risk for
treatment-related complications
Patients who don't have an intact GI tract and those who are unable to take oral medications
Men of childbearing potential not willing to use effective means
of contraception
Requirement for concurrent use of the antiviral agent sorivudine
or chemically related analogues, such as brivudine
Organ allografts requiring immunosuppressive therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the efficacy of bevacizumab in combination with<br>capectabine, based on progression free survival (PFS).;Secondary Objective: To evaluate the safety profile of bevacizumab in combination<br>with capecitabine<br> To determine the overall response rate (RR), time to response,<br>duration of response and overall survival (OS) of bevacizumab in<br>combination with capecitabine;Primary end point(s): PFS, defined as the time period from thedate of randomisation until disease progression or death, whichever<br>occurs first.
- Secondary Outcome Measures
Name Time Method