A randomized, open-label Phase III study to assess efficacy and safety of bevacizumab in combination with capecitabine as first line treatment for elderly patients with metastatic colorectal cancer - AVEX: Avastin in Elderly with Xeloda

F. Hoffmann-La Roche Ltd.0 sites430 target enrollmentFebruary 20, 2007

ConditionsFirst line metastatic colorectal carcinoma MedDRA version: 8.1Level: LLTClassification code 10052358Term: Colorectal cancer metastatic

DrugsAvastin

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: First line metastatic colorectal carcinoma
Sponsor: F. Hoffmann-La Roche Ltd.
Enrollment: 430
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 20, 2007

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

F. Hoffmann-La Roche Ltd.

Eligibility Criteria

Inclusion Criteria

•1\) Written informed consent (approved by the Institutional Review Board \[IRB] / Independent Ethics Committee \[IEC]) obtained prior to any study specific screening procedures
•2\) Age \>\= 70 years
•3\) Patient must be able to comply with the protocol
•4\) Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of metastases (new confirmation of metastatic disease is required in case the time interval from last histological/cytological diagnosis to enrolment exceeds 3 years)
•5\) Diagnosis of metastatic disease not more than 6 months prior to enrolment
•6\) At least one measurable metastatic lesion, measurable or at least evaluable disease (as per RECIST criteria)
•7\) Prior adjuvant (or neo\-adjuvant for rectal cancer patients) chemotherapy allowed if completed more than 6 months before inclusion
•8\) ECOG performance score of 0 – 2
•9\) Life Expectancy of at least 3 months
•10\) Adequate haematological function: ANC \>\= 1\.5 x 10Exp9/L; platelets \>\= 100 x 10Exp9/L, Hb \>\= 9 g/dL

Exclusion Criteria

•1\) Patients who received adjuvant antiVEGF treatment
•2\) Prior chemotherapeutic treatment for metastatic CRC
•3\) Clinical evidence of brain metastases or history or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy or history of stroke) or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake
•4\) 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)
•5\) 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
•6\) Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study
•7\) Known hypersensitivity to any of the study drugs
•8\) Current or recent (within 10 days of first dose of study treatment) daily use of aspirin (\> 325 mg/day) or other NSAID
•9\) 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
•10\) History of thromboembolic or haemorrhagic events within 6 months prior to treatment