Study of Bevacizumab in Combination with Alternating XELIRI and XELOX in Metastatic Colorectal Cancer

Launched by PIA OSTERLUND · Feb 8, 2012

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for patients with metastatic colorectal cancer, which means the cancer has spread beyond the colon. The researchers want to see how effective a combination of a drug called bevacizumab (also known as Avastin) and two types of chemotherapy, Xeliri and Xelox, can be when given as the first treatment for this condition. They will be looking at how long patients can go without their disease getting worse, as well as other factors like the chance of surgery being successful, how well patients respond to the treatment, their quality of life, and the safety of the drugs.

To be eligible for this trial, participants need to be adults over 18 years old with a confirmed diagnosis of colorectal cancer that has not been treated with chemotherapy for metastatic disease before. They should also have measurable cancer, a good overall health status, and a life expectancy of at least three months. Participants can expect to be closely monitored throughout the study, and their progress will be tracked to determine the effectiveness and safety of the treatment. It’s important for potential participants to discuss any previous treatments or health issues with their doctor to ensure they meet the trial's requirements.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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
• • 2. Age \> 18
• • 3. Measurable or evaluable metastatic disease
• • 4. Performance status Eastern co-operative oncology group (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 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
• • 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 central nervous system (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 clopidogrel (\> 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