This phase 2 trial located in Maryland, United States, aims to determine whether a combination of gemcitabine (Gemzar) and docetaxel (Taxotere)is effective in patients with metastatic colorectal adenocarcinoma with CHFR and/or microsatellite instability. Patient's resposne to treatment will be measured.
The details
Microsatellite instability (repeated sequences of DNA) is thought to occur when there are problems with repairing errors in DNA replication (copying). It can lead to colorectal cancer. In colorectal cancer, patients with microsatellite instability have a better outcome than patients who do not have microsatellite instability. Patients with microsatellite instability also respond differently to treatment. CHFR is a protein involved in many cell processes. When it is methylated (when a particular molecule is added to the protein), cell processes are changed. Patients with CHFR methylation are thought to also respond differently to treatment.
This trial will measure the effectiveness of gemcitabine and docetaxel in patients with microsatellite instability and/or CHRF methylation. Treatment response will be measured through the length of time patients respond to these treatments.
Who are they looking for?
This study is recruiting 40 particpants with colorectal adenocarcinoma that has spread to other parts of the body or cannot be removed by surgery. Participants should not have responded well or are intolerant to one or more chemotherapy regimens. Participants should have microsatellite instability and CHFR methylation. This can be determined by a biopsy (tissue sample removed for analysis). Participants should have normal organ function.
Participants should not be pregnant. Patients must not have any active infections or symptomatic heart disease.
How will it work
All patients will receive gemcitabine injected into the vein on days 1 and 8. They will receive docetaxel on day 8 of each 21 day cycle. Patients will receive filgrastim (G-CSF, Granix) on days 9 through 15 or pegfilgrastim (Neulasta) on day 9 or 10 of each cycle. Patients will be followed-up for up to 4 years.
