Metastatic colorectal cancer
Conditions
Sponsors
Department of Oncology, Linköping University Hospital, Linköping, Sweden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o Untreated metastatic colorectal carcinoma o Age = 70 years o Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST) criteria o Eastern Cooperative Oncology Group (ECOG) performance status =2 o Life expectancy more than 3 months but not considered optimal candidate for treatment with combination chemotherapy with oxaliplatin or irinotecan o Adequate haematological, renal and liver function as measured by: ? haemoglobin >90 g/L ? absolute neutrophil count = 1,5 x 109/L ? platelets = 100 x 109/L ? bilirubin =1.5 × ULN ? ALAT= 2.5 × ULN (=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: o Adjuvant therapy within 6 months o Clinically significant (i.e. active) cardiovascular disease, e.g: ? cerebrovascular accidents = 6 months prior to study enrolment ? myocardial infarction = 6 months prior to study enrolment ? unstable angina ? congestive heart failure (NYHA Grade II or greater) ? serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment. o Surgical procedure or significant traumatic injury within 28 days prior to first study treatment, or anticipation of need for major surgical procedure during the course of the study. o Any other serious or uncontrolled illness, which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibility of continous treatment with bevacizumab beyond disease progression in an elderly community based patient population by assessment of overall survival;Secondary Objective: To assess safety, treatment duration, progression free survival, patient reported outcomes, overall response and tumor biomarker expression in elderly patients treated with bevacizumab beyond disease progression. ;Primary end point(s): Overall survival from time of enrolment;Timepoint(s) of evaluation of this end point: Survival follow-up throughout the study and every three months after teminated study participation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety Total treatment duration Treatment duration from first progression Progression free survival Patient reported outcomes Overall response rate Tumor biomarker expression;Timepoint(s) of evaluation of this end point: Safety is assessed throughout the study at every patient visit. Any serious adverse events or adverse events of special interest is follwed until return to baseline, stabilization or death. Total treatment duration and treatment duration from first progression is followed until last treatment dose is received Progression free survival is assessedd every 9-12 weeks and every three monts after study termination until disease progression or death. Patient reported outcomes are assessed before every treatment upto 30 days after last treatment Overall response rate is assessedd every 9-12 weeks Tumor biomarker expression is assessed in tumour material obtained during the screening phase | — |
Countries
Sweden
Contacts
Public ContactDept of Onc, Linköping Uni Hospital
Department of Oncology, Linköping University Hospital
Outcome results
None listed