A clinical trial to investigate efficacy and safety of continous treatment with bevacizumab together with chemotherapy in elderly patients with metastasized colorectal cancer

Phase 1

• Conditions: Metastatic colorectal cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003844-11-SE
• Lead Sponsor: Department of Oncology, Linköping University Hospital, Linköping, Sweden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-09
• Study Completion: 2018-12-11
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

oUntreated metastatic colorectal carcinoma
oAge = 70 years
oMeasurable disease according to Response Evaluation Criteria in solid Tumors (RECIST) criteria
oEastern Cooperative Oncology Group (ECOG) performance status =2
oLife expectancy more than 3 months but not considered optimal candidate for treatment with combination chemotherapy with oxaliplatin or irinotecan
oAdequate 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 (<5 × ULN if liver metastases)
?creatinine =1.5 × ULN
?PK = 1.5
?APTT <1.5 ULN
?Urine dipstick of proteinuria <2+

oTumor tissue available for biomarker analysis.
oSigned written informed consent to the clinical study and translational research according to ICH/GCP and the local regulations will be obtained prior to any study specific screening procedures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 100

Exclusion Criteria

oAdjuvant therapy within 6 months
oClinically 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.
oSurgical 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.
oAny other serious or uncontrolled illness, which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Safety<br>Total treatment duration<br>Treatment duration from first progression<br>Progression free survival<br>Patient reported outcomes<br>Overall response rate<br>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.<br>Total treatment duration and treatment duration from first progression is followed until last treatment dose is received<br>Progression free survival is assessedd every 9-12 weeks and every three monts after study termination until disease progression or death.<br>Patient reported outcomes are assessed before every treatment upto 30 days after last treatment<br>Overall response rate is assessedd every 9-12 weeks <br>Tumor biomarker expression is assessed in tumour material obtained during the screening phase