Patients with inoperable locally advanced or metastatic colorectal cancer, who have not previosly received systemic treatment for metastatic disease. MedDRA version: 14.1 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Avastin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Bevacizumab
Concentration unit: mg milligram(s)
Concentration number: 100-
Trade Name: Avastin
Phar
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven diagnosis of colorectal cancer 2. Locally advanced or metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease 3. Age >= 18 4. ECOG Performance Status 0-1 5. Life expectancy of at least 12 weeks 6. Measurable and/or evaluable lesions according to RECIST criteria 7. Laboratory requirements: Neutrophils >= 1.5 x 109/L and Platelets >= 100 x 109/L Total bilirubin 50 mL/min or serum creatinine = 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Radiotherapy to any site within 4 weeks before the study. 2. Untreated brain metastases or spinal cord compression or primary brain tumours. 3. History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy or history of stroke). 4. History of inflammatory bowel disease and/or acute/subacute bowel occlusion. 5. Serious, non-healing wound, ulcer, or bone fracture. 6. Evidence of bleeding diathesis or coagulopathy. 7. Uncontrolled hypertension. 8. 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. 9. Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes. 10. Chronic, daily treatment with high-dose aspirin (>325 mg/day). 11. Treatment with any investigational drug within 30 days prior to enrolment. 12. Patients with known allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications. 13. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ. 14. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study. 15. Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication. 16. Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study. 17. Symptomatic peripheral neuropathy ≥grade 1 according the NCI Common Toxicity Criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate toxicity and the safety profile of the combination To evaluate duration of response (DR), time to progression (TTP), time to treatment failure (TTF), and overall survival (OS) at the end of the study.;Primary end point(s): - Complete remission (CR): complete disappearance of all previously detectable disease for a period of at least 28 days, and no new lesions. - Adverse events, laboratory parameters. All toxicity will be graded using the NCI common toxicity criteria version 3.0.;Main Objective: To assess the preliminary antitumor activity in terms of overall response rate (complete and partial responses) of the combination of bevacizumab and capecitabine plus oxaliplatin in patients with advanced colorectal cancer. | — |
Countries
Italy
Outcome results
None listed