The Phase II Clinical Trial
Phase II trials follow on from Phase I trials and continue to test the safety of a drug or combination of drugs. Patients participating in the trial will receive the study drug at regular intervals for a set period of time (e.g. 6 cycles) or indefinitely unless there is evidence that their cancer is growing despite the treatment or they experience significant side effects. Unlike Phase I trials, patients in a phase II trial usually test a set (pre-determined) dose of the drug rather than a series of doses in a dose-escalation. To be eligible for a Phase II trial, patients need to have measurable disease, i.e. at least tumour should be present in the body that can be seen and measured on a CT scan (or X-Ray, MRI scan or PET scan). As with phase I clinical trials, the size of the tumour is tracked and measured using regular scans:
These early phase clinical trials are a very good way of testing new treatments, some of which are prove to be effective at shrinking or stabilising cancers. However, not every person is eligible to enter an early phase clinical trial, particularly if there are other standard treatments they have not yet had or if they have pre-existing medical conditions, abnormal organ function or are too physically unwell from their cancer to participate.