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Phase 2 Study of Bevacizumab in Combination With Alternating Xeliri and Xelox as First-line Treatment of Patients With Metastatic Colorectal Cancer

Phase 2
18 Years
Open (Enrolling)
Metastatic Colorectal Cancer

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Trial Information

Phase 2 Study of Bevacizumab in Combination With Alternating Xeliri and Xelox as First-line Treatment of Patients With Metastatic Colorectal Cancer

Inclusion Criteria:

1. Patients with histologically confirmed diagnosis of 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

2. Age > 18

3. Measurable or evaluable metastatic disease

4. Performance status ECOG performance status 0-2

5. Life expectancy greater than 3 months

6. Normal Thrombocytes, neutrophils, Aspartate amino transferase/Alanine amino
transferase, Alkaline phosphatase, Serum bilirubin, Serum Creatinine, Urine dipstick
of proteinuria.

7. 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

8. 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

9. Patient must be able to comply with the protocol

Exclusion Criteria:

1. Prior treatment with first-line chemotherapy for metastatic CRC

2. Adjuvant treatment within 6 months

3. 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)

4. Near future planned radiotherapy for underlying disease (prior completed radiotherapy
treatment allowed)

5. Clinical or radiological evidence of CNS metastases

6. 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

7. Serious non-healing wound or ulcer

8. Evidence of bleeding diathesis or coagulopathy

9. Uncontrolled hypertension

10. 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

11. Treatment with any investigational drug within 30 days prior to enrolment

12. 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

13. Chronic daily intake of aspirin (> 325 mg/day) or clopidogren (> 75 mg/day)

14. Pregnancy (positive serum pregnancy test) and lactation

15. Any other serious or uncontrolled illness which, in the opinion of the investigator,
makes it undesirable for the patient to enter the trial

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

To assess overall resectability in patients with metastatic colorectal cancer, postoperative morbidity and outcomes after resection

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Pia Osterlund, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Helsinki University Central Hospital


Finland: Finnish Medicines Agency

Study ID:




Start Date:

February 2012

Completion Date:

December 2025

Related Keywords:

  • Metastatic Colorectal Cancer
  • metastatic colorectal cancer
  • Colorectal Neoplasms