metastatic colorectal cancer MedDRA version: 8.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with histological confirmed diagnosis of metastatic CRC and disease progression (at least one measurable lesion according to RECIST assessed by investigator, documented by CT or MRI), previously treated with first-line Therapy (Bevacizumab and Fluoropyrimidin / Oxaliplatin based or Bevacizumab and Fluoropyrimidin/ Irinotecan based CTx) and no candidates for primary metastectomy. - Evaluation of tumour disease according to RECIST by investigator, 4 weeks or less prior to start of study treatment - No major surgery within 4 weeks prior to start of study treatment. Wound healing has to be completed - Age =18 years - ECOG = 2 - Signed written informed consent - Fertile women and men of childbearing potential (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Diagnosis of progression of disease more than 3 m after last Bevacizumab (BV) administration • First Line patients who had a PFS in first-line of 150 mmHg and/or diastolic blood pressure > 100 mmHg • Prior history of hypertensive crisis or hypertensive encephalopathy • NYHA Class II or greater CHF • History of myocardial infarction or unstable angina within 6 m prior to start of study treatment • Known CNS disease, expect for treated brain metastasis (treated brain metastases are defined as having no evidence of progression or haemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging during the screening period. Anticonvulsants are allowed. Treatment for brain metastases may include whole brain radiotherapy, radiosurgery or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 m of start of study therapy will be excluded. • Significant vascular disease (e.g. aortic aneurysm requiring surgical intervention, pulmonary embolism or recent peripheral arterial thrombosis) within 6 m prior start of study treatment. • History of haemoptysis (= ½ tsp of bright red blood per episode) within 1 m prior start of study treatment • Evidence of bleeding diathesis or significant coagulopathy (in absence of therapeutic anticoagulation) • Major surgical procedure, open biopsy, or significant traumatic injury within 28 d prior to start of study therapy, or anticipation of need for major surgical procedure during the course of the study • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 d prior start of study therapy • History of abdominal fistula, tracheo-oesophageal fistula or any grade 4 non-gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abcess before 1st line therapy • Serious, non healing wound, active ulcer, or untreated bone fracture • History or evidence upon physical/neurological examination of CNS disease (unrelated to cancer) (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures • Past or current history (within the last 2 years prior to treatment start) of other malignancies except metastatic colorectal cancer (patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible) • Known hypersensitivity to any of the study drugs • Acute intra abdominal inflammatory process • Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications • Patients with contraindication for cross over chemotherapy (e.g. patients treated with irinotecan based first line therapy and ser
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess Overall survival (OS);Secondary Objective: - To assess OS from time of starting first line therapy - To assess PFS (after first progression) overall and on treatment population - To evaluate the Response rate (RECIST) - To evaluate the Safety profile in both arms Exploratory objectives: - To investigate the correlation between biomarkers (in tumor and blood) associated with metastatic colorectal cancer and therapeutic response to Bevacizumab and different chemotherapy regimens ;Primary end point(s): - To assess Overall survival (OS). | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Netherlands, Portugal, Spain, Sweden
Outcome results
None listed