metastatic colorectal cancer
Conditions
Interventions
Patients will receive intravenous gemcitabine 500mg/m2 on days 1 and 8 and
docetaxel 70mg/m2 on day 8 of each 21 day cycle
Patients will receive filgrastim (G-CSF) on days 9 through 15 or pegfilgrast
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: histologically or cytologically confirmed metastastic or unresectable colorectal adenocarcioma measurable disease intolerant or refractory to one or more standard lines of chemotherapy age>18 ECOG 0-1 life expectancy of greater than 12 weeks normal organ and marrow function MSI phenotype of archival tissue biopsy determined by PCR and IHC CHFR gene promoter methylation in archival tissue biopsy ability to understand and willingness to sign a written informed consent document
Exclusion criteria
Exclusion criteria: chemotherapy or radiotherapy within 4 weeks prior to entering study, or not being recovered from adverse events. receiving any other investigational agents known brain metastases history of allergic reactions attributed to cmpounds of simiar chemical or biological composition to gemcitabine or docetaxel. receiving any medications or substances thtat are inhibitors or inducers of CYP3A4 uncontrolled intercurrent illness pregnant women HIV positive patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objectives Determine the response rate of gemcitabine and docetaxel combination therapy for treatment of relapsed or refractory metastatic colorectal adenocarcinoma with methylation of CHFR and/or microsatellite instability | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives Determine the progression free survival with gemcitabine and docetaxel combination therapy in the selected patient population Determine the overall survival with gemcitabine and docetaxel combination therapy in the selected patient population Assess CHFR methylation in circulating tumor DNA and compare to CHFR methylation observed in tumor tissue Assess changes in CHFR methylation in circulating tumor DNA over the time of therapy to determine if CHFR demethylation occurs as a predictor of progression Analyze tumor tissue using a global methylation approach to develop a more robust predictive signature of treatment response Evaluate changes in quality of life for patients treated with this regimen by serial measurements using the QLQ-C30 and QLQ-CR29 questionnaire. | — |
Countries
Netherlands
Outcome results
None listed