Phase 2 Study of Bevacizumab in Combination with Alternating XELIRI and XELOX As First-line Treatment of Patients with Metastatic Colorectal Cancer

Pia Osterlund1 site in 1 country100 target enrollmentFebruary 2012

Overview

Open-label, single-arm, phase II study of bevacizumab (AvastinTM) in combination with alternating XELIRI (capecitabine+irinotecan) and XELOX (capecitabine+oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.
Primary objective: Progression Free Survival (PFS),
To assess overall resectability in patients with metastatic colorectal cancer, postoperative morbidity and outcomes after resection.
Secondary objectives: To assess response rates according to RECIST criteria, failure free survival (TTF) and overall survival (OS), Quality of life according to 15-dimensional instrument (15D) questionnaire, To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria, Biomarker evaluation to measure plasma biomarkers, tumour blocks and DNA polymorphisms that may predict drug effects, safety, resectability and clinical behaviour of the tumour

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

December 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Pia Osterlund

Responsible Party

Sponsor Investigator

Principal Investigator

Pia Osterlund

Principal Investigator

Helsinki University Central Hospital

•Patients with histologically confirmed diagnosis of colorectal cancer (CRC), chemotherapy naïve for metastatic disease (prior adjuvant chemotherapy more than 6 months previously for CRC allowed), who are scheduled to start first line chemotherapy for metastatic disease
•Measurable or evaluable metastatic disease
•Performance status Eastern co-operative oncology group (ECOG) performance status 0-2
•Life expectancy greater than 3 months
•Normal Thrombocytes, neutrophils, Aspartate amino transferase/Alanine amino transferase, Alkaline phosphatase, Serum bilirubin, Serum Creatinine, Urine dipstick of proteinuria.
•Women of childbearing potential must have a negative serum pregnancy test done prior to the administration of bevacizumab. Patient and their partner should have adequate contraception up to at least 6 months after last treatment completion or the last drug dose, whatever happens first
•Signed written informed consent according to international council for harmonization (ICH)/Good clinical practice (GCP) and the local regulations (approved by the Independent Ethics Committee (IEC)) will be obtained prior to any study specific screening procedures
•Patient must be able to comply with the protocol

•Prior treatment with first-line chemotherapy for metastatic CRC
•Adjuvant treatment within 6 months
•Major surgical procedure (placing of central venous access device and liver biopsy etc are considered minor procedure), open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery)
•Near future planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed)
•Clinical or radiological evidence of central nervous system (CNS) metastases
•Past or current history within the last 2 years of malignancies except for the indication under this study and curatively treated basal and squamous cell carcinoma of the skin or in-situ carcinoma of the cervix
•Serious non-healing wound or ulcer
•Evidence of bleeding diathesis or coagulopathy
•Uncontrolled hypertension
•Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication