None listed
Conditions
Brief summary
This is a randomized phase III trial of irinotecan in combination with capecitabine or 5-Fluorouracil/Leucovorin and bevacizumab: (xeliri-bevacizumab vs folfiri-bevacizumab) as first-line treatment in patients with metastatic colorectal cancer. The primary objective of this study is to test the antineoplastic activity, expressed as progression-free survival, of XELIRI regimen vs FOLFIRI, in patients with metastatic colorectal cancer not previously treated for advanced disease. The secondary objectives are to evaluate the convenience and safety of the two regimens as well as to evaluate the response rate and the overall survival.
Interventions
Bevacizumab (AVASTIN): 7.5 mg/kg of body weight, 90min intravenous (i.v.) infusion day 1 (AVASTIN should not be mixed into Dextrose solutions)
followed by
Irinotecan (CPT-11): 240mg/m2 intravenous (i.v.), 90 minutes infusion day 1
followed by
Capecitabine (XELODA):1000 mg/m2 per os (it is administered orally within 30 minutes after the end of breakfast or dinner) twice daily days 1-14
The regimen will be repeated every 3 weeks for a total of 6 cycles. Treatment should be continued for 6 cycle
Bevacizumab (AVASTIN): 7.5 mg/kg of body weight, 90min intravenous (i.v.) infusion day 1 (AVASTIN should not be mixed into Dextrose solutions) followed by Irinotecan (CPT-11): 240mg/m2 intravenous (i.v.), 90 minutes infusion day 1 followed by Capecitabine (XELODA):1000 mg/m2 per os (it is administered orally within 30 minutes after the end of breakfast or dinner) twice daily days 1-14 The regimen will be repeated every 3 weeks for a total of 6 cycles. Treatment should be continued for 6 cycles and be interrupted in case of progression of disease during treatment or non-acceptable toxicity or consent withdrawal. After the end of treatment, patients are followed every 3 months until death or until the date of interruption (date of disease progression or initiation of other antineoplastic treatment).
Sponsors
Hellenic Cooperative Oncology Group
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Histologically or cytologically documented locally advanced or metastatic colorectal cancer 2.Two-dimensional measurable disease at least at one site, not previously irradiated (newly emerged disease at previously irradiated sites is acceptable). Ascites and pleural fluid are not considered measurable disease. 3. The diameter of one measurable lesion should be (at least one dimension)>=15 mm 4. No previous administration of chemotherapy (only neoadjuvant or adjuvant chemotherapy completed at least 4 months before patient enrollment in the protocol is acceptable). 5. Time between other anticancer treatments and patient enrollment should be:>= 4 weeks for major surgical intervention · >= 4 weeks for radiotherapy 6. Age>=18 years and performance status ECOG (Eastern Cooperative Oncology Group) 0-2 7. Expected life span > 3 months 8. Written informed consent 9. Adequate bone marrow function: Hemoglobin >= 10 gr/dL White blood cell >= 4 x 10^9/ L Neutrophils >= 2 x 10^9/ L Platelets >= 100 x 10^9/ L 10. Adequate hepatic and renal function Total bilirubin <= 1.5 x UNL Serum glutamic oxaloacetic transaminase (SGOT) <= 2.5 x UNL Serum glutamic pyruvic transaminase (SGPT)<= 2.5 x UNL Alkaline phosphates <= 2.5 x UNL Creatinine <= 1.5 x UNL 11. In case of liver metastases: Total bilirubin <= 2.5 x UNL Serum glutamic oxaloacetic transaminase (SGOT) <= 5.0 x UNL Serum glutamic pyruvic transaminase (SGPT) <= 5.0 x UNL Alkaline phosphatase <= 5.0 x UNL 12. In case of bone metastases: Alkaline phosphatase <= 10.0 x UNL UNL: Upper normal limit of approved normal values.
Exclusion criteria
1.Malignant tumors other than colorectal adenocarcinoma 2.History of other malignant disease, excluding non-melanoma cancer of the skin and in-situ cervical cancer 3.Concomitant irradiation of a measurable lesion 4.Other concomitant anticancer treatment 5.Concomitant (or in the last 4 weeks before patient enrollment) administration of other investigational drugs 6.Measurable liver lesion affecting >50% of organ function 7.Other serious concomitant diseases or compromised general condition, including major neurological and psychiatric disorders 8.Severe cardiac disease (congestive heart failure, symptomatic coronary insufficiency, history of myocardial infarction in the last 6 months, uncontrolled high-risk arterial hypertension or uncontrolled cardiac arrhythmia) 9.Uncontrolled metabolic disorders (unstable diabetes mellitus or other contraindications to corticosteroids) or serious uncontrolled active infection 10.Brain metastases and patients with bone metastases or serosal effusions as the only sites of disease 11.Inflammatory bowel disease or loss of proximal gastrointestinal tract integrity or malabsorption syndrome 12.Complete or partial bowel obstruction 13. Current history of chronic diarrhea 14.The patient had a major surgical operation in the last 4 weeks before enrollment and has not recovered yet 15.Pregnant or breastfeeding women 16.Female fertile patients not using an appropriate form of contraception 17.Patients with allo-transplanted organs 18.Inadequate follow-up because of psychological, socioeconomic, or other factors.
Outcome results
None listed