Single center, open labeled, phase 2 clinical trial, where patients with metastatic colorectal cancer are selected for treatment with dose dense Cyclophosphamide every second week based on TP53 mutation status; i.e. only patients with TP53 mutated tumors may be included in the treatment arm.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Chemotherapy
Haukeland University Hospital
Bergen, Norway
Objective response rate (ORR)
Partial response (PR) or complete response (CR) as defined by the RECIST criteria
Time frame: 4 months
Possible molecular markers of therapy response/resistance and survival outcome beyond TP53 mutations will be examined.
Tissue and blood sampling at baseline and whenever treatment is changed
Time frame: 10 years
Number of patients with treatment response among patients harboring TP53 mutations belonging to particular mutation subgroups
Tissue and blood sampling at baseline and whenever treatment is changed
Time frame: 10 years
Clinical benefit rate (CBR)
Stable disease (SD) \>6 months, PR or CR
Time frame: 5 years
Recurrence-free and overall survival, compared to historical data
Survival analyses
Time frame: All patients will be followed for 5 years or until death to record survival outcome
Safety and tolerability of the study treatment including recording of number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Clinical examination and blood samples
Time frame: Every second week during the treatment period from start of treatment, and thereafter every second month for 5 years or until death
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