Adjuvant treatment for patients who have undergone surgery for Colon cancer, AJCC/UICC high-risk Stage II & stage III MedDRA version: 7 Level: PT Classification code 10009954
Conditions
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent obtained prior to any study specific screening procedures. 2. Patient must be willing and able to comply with the protocol. 3. Age = 18. 4. Histologically confirmed colon carcinoma, AJCC/UICC Stage II or Stage III defined as a tumour location =15 cm from the anal verge by endoscopy or above the peritoneal reflection at surgery. The patient must not be a candidate for (neo) adjuvant radiotherapy. Note! Stage II patients have to be considered as high-risk patients fulfilling one of the following criteria: – T4 tumours, – Patients presenting with bowel obstruction or perforation, – Histological signs of vascular invasion (i.e. blood and lymphatic vessels) or perineural invasion, – Patients aged less than 50 years, – Patients with sub-optimal surgery (less than 12 nodes analyzed). 5. Curative surgery not less than 4 and not more than 8 weeks prior to randomization. 6. ECOG performance status 0 or 1. 7. Life expectancy of = 5 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Macroscopic or microscopic evidence of remaining tumour. Patients should never have had any evidence of metastatic disease (including presence of tumour cells in the ascites). The isolated finding of cytokeratin positive cells in bone marrow is not considered evidence of metastatic disease for purposes of this study. 2. Carcinoembryonic antigen > 1.5 x ULN after surgery (during screening period). 3. For patients with colostomy, unwilling to delay revision until at least 28 days after treatment completion. 4. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, not fully healed wounds, or anticipation of the need for major surgical procedure during the course of the study. CVAD for chemotherapy administration must be inserted at least 2 days prior to treatment start. 5. Previous anti-angiogenic treatment for any malignancy; cytotoxic chemotherapy, radiotherapy or immunotherapy for colon cancer. 6. Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix). 7. Females with a positive or no pregnancy test (within 7 days before treatment start) unless childbearing potential can be otherwise excluded (postmenopausal i.e. amenorrheic for at least 2 years, hysterectomy or oophorectomy). 8. Lactating women. 9. Fertile women (325mg/day) or nonsteroidal antiinflammatory medications (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases). Patients can be rendered eligible by changing the treatment to COX II inhibitors. 21. Chronic treatment with corticosteroids (dose of = 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids). 22. Serious intercurrent infections (uncontrolled or requiring treatment). 23. Known dihydropyrimidine dehydr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives of the study were: • To demonstrate that the combination of bevacizumab and FOLFOX-4 is superior to FOLFOX-4 alone in terms of disease-free survival in chemotherapy-naïve patients who underwent surgery with curative intent for colon carcinoma. • To demonstrate that the combination of bevacizumab and XELOX is superior to FOLFOX-4 alone in terms of disease-free survival in chemotherapy-naïve patients who underwent surgery with curative intent for colon carcinoma. In case both primary objectives were achieved, one secondary objective was to further investigate if the combination of bevacizumab and XELOX is at least as efficacious as the combination of bevacizumab and FOLFOX-4 in terms of disease-free survival and overall survival. The primary efficacy analysis (cut-off date: 30th June 2010) showed that the study did not meet the co-primary objectives of prolonging disease-free survival in stage III colon carcinoma patients. ;Secondary Objective: • To further follow-up patients in terms of overall survival. • To further evaluate and compare the safety profiles of the treatment groups. • To evaluate the immunogenicity of bevacizumab measured as induction of HAHA (completed with the primary efficacy analysis).;Primary end point(s): Disease free survival determined when approximately 836 events have occurred. | — |
Countries
Czech Republic, Finland, Germany, Hungary, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed