Study of Bevacizumab in Combination With Alternating Xeliri and Xelox in Metastatic Colorectal Cancer

  • STATUS
    Recruiting
  • End date
    Dec 21, 2025
  • participants needed
    100
  • sponsor
    Pia Osterlund
Updated on 21 January 2021
serum bilirubin level
metastasis
neutrophil count
bevacizumab
adjuvant chemotherapy
proteinuria
xelox regimen
xeliri

Summary

  • Open-label, single-arm, phase II study of bevacizumab (AvastinTM) in combination with alternating Xeliri and Xelox as first-line treatment of patients with metastatic colorectal cancer.
    • Primary objective: 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 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

Details
Condition Metastatic Colorectal Cancer
Treatment Bevacizumab plus alternating Xelox/Xeliri
Clinical Study IdentifierNCT01531595
SponsorPia Osterlund
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with histologically confirmed diagnosis of CRC, chemotherapy nave 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
Age > 18
Measurable or evaluable metastatic disease
Performance status 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 ICH/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

Exclusion Criteria

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 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
Treatment with any investigational drug within 30 days prior to enrolment
Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the treatment or patient at high risk from treatment complications
Chronic daily intake of aspirin (> 325 mg/day) or clopidogren (> 75 mg/day)
Pregnancy (positive serum pregnancy test) and lactation
Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
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