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

This study is currently recruiting participants.
Verified February 2012 by Helsinki University Central Hospital
Sponsor:
Information provided by (Responsible Party):
Pia Osterlund, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01531595
First received: February 3, 2012
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  Purpose
  • 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 Intervention Phase
Metastatic Colorectal Cancer
 Drug: Bevacizumab plus alternating Xelox/Xeliri
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Resectability [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To assess overall resectability in patients with metastatic colorectal cancer, postoperative morbidity and outcomes after resection

  • Efficacy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    progression free survival


Secondary Outcome Measures:
  • Response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To assess response rates according to RECIST criteria


Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531595

Contacts
Contact: Pia Osterlund, MD +358-9-4711 pia.osterlund@hus.fi

Locations
Finland
Department of Oncology Recruiting
Helsinki, Finland
Contact: Pia Osterlund, MD     +358-9-4711     pia.osterlund@hus.fi    
Principal Investigator: Pia Osterlund, MD            
Principal Investigator: Helena Isoniemi, MD            
Sponsors and Collaborators
Pia Osterlund
Investigators
Principal Investigator: Pia Osterlund, MD Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Pia Osterlund, Principal Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01531595     History of Changes
Other Study ID Numbers: 2011-003137-33
Study First Received: February 3, 2012
Last Updated: February 8, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
metastatic colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013