About Clinical Trials
Clinical trials represent an important part of cancer research. The testing of new medications to either treat cancer or relieve side effects are critical to advancing the care and management of patients with cancer. Not all patients may be candidates for research studies and in some cases; studies may not be available for a particular diagnosis or stage of cancer. However, our philosophy is that only through research can advances be made and only through advances, can cancer be slowed or cured. Pinnacle Oncology is proud of the fact that we provide our patients with access not only to the most up-to-date new drugs via our relationship with our industry partners but that we are also a national site for the National Surgical Breast and Bowel Project (NSABP), one of the National Institute of Health funded cooperative research groups.
There are different types of clinical trials that involve patient participation. Most, involve the study of a new drug or treatment. They are separated into three general “phases” of research described below:
Phase I trials represent the newest drugs entering into clinical trials. In these studies, new drugs, oftentimes previously not tested in patients, are offered to patients with cancer that has not responded to available standard therapies or for whom no effective standard therapy exists. The goal of phase I trials is to understand the side effects of the new drug and to derive a dose that represents a safe and hopefully effective dose for future study. Some phase I trials combine a new drug with an old standard drug or standard regimen. These phase IB trials are typically looking at the safety of the combination of the drugs. Phase I trials typically are called dose escalation trials because when you enter the trial will often determine what dose of drug you will receive based upon the tolerance of the patients before you.
Phase II trials follow the initial safety trials of new drugs and are designed to answer the question “how active is this drug in a particular form of cancer?”. Phase II trials take the dose derived from the phase I trials and study them in a group of patients who are similar for their diagnosis (same type of cancer) and often the extent of their prior therapy. These trials will often include 25-75 patients and while continuing to study the safety of the drug, the goal is to decide whether the degree of anti-cancer activity warrants continued study.
Phase III trials are the most advanced of the three phases of clinical investigation. In these trials the new and hopefully active/effective drug is compared to the previously established standard-of-care therapy. In some settings, the standard-of-care may be no treatment and a placebo control may be used to decide if the new drug is better than close observation and monitoring. If a placebo is used, you would be aware of this possibility but would likely not know to which arm of the trial (experimental or standard) you have been assigned. The results of phase III trials are typically what determine whether or not a new drug has proven to be better than older established drugs, paving the way for their approval by the Food and Drug Administration or other governing agencies in other countries.
Supportive Care Trials
Some clinical trials are focused not on the actual treatment of cancer but rather on reducing the side effects of treatment. Such side effects can include numbness and tingling, low blood counts, nausea or vomiting, etc. While these studies may not result in better control of cancer, they can potentially make cancer treatments more tolerable. Occasioanly research studies have nothing to do with treatment of the cancer or side effects. Examples of this may include imaging studies to test new forms of imaging, aiding in the diagnosis or evaluation of cancer or samples of blood or tumor to analyze their sensitivity to new drugs in the laboratory.