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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01531595
Recruitment Status : Recruiting
First Posted : February 13, 2012
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):
Pia Osterlund, Helsinki University Central Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Bevacizumab plus alternating Xelox/Xeliri Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Bevacizumab in Combination With Alternating Xeliri and Xelox as First-line Treatment of Patients With Metastatic Colorectal Cancer
Study Start Date : February 2012
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Chemotherapy plus bevazicumab Drug: Bevacizumab plus alternating Xelox/Xeliri
3 cycles of XELOX+bevacizumab alternating with 3 cycles XELIRI+bevacizumab until disease progression
Other Names:
  • Avastin
  • Xeloda
  • irinotecan
  • oxaliplatin

Primary Outcome Measures :
  1. Resectability [ Time Frame: 5 years ]
    To assess overall resectability in patients with metastatic colorectal cancer, postoperative morbidity and outcomes after resection

  2. Efficacy [ Time Frame: 5 years ]
    progression free survival

Secondary Outcome Measures :
  1. Response [ Time Frame: 5 years ]
    To assess response rates according to RECIST criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 complications
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01531595

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Contact: Pia Osterlund, MD +358-9-4711

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Department of Oncology Recruiting
Helsinki, Finland
Contact: Pia Osterlund, MD    +358-9-4711   
Principal Investigator: Pia Osterlund, MD         
Principal Investigator: Helena Isoniemi, MD         
Sponsors and Collaborators
Pia Osterlund
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Principal Investigator: Pia Osterlund, MD Helsinki University Central Hospital
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Responsible Party: Pia Osterlund, Principal Investigator, Helsinki University Central Hospital Identifier: NCT01531595    
Other Study ID Numbers: 2011-003137-33
First Posted: February 13, 2012    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015
Keywords provided by Pia Osterlund, Helsinki University Central Hospital:
metastatic colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action