Early Phase Clinical Trials

Cancer clinical trials progress in a step-by-step approach to evaluate and approve the latest drug therapies or surgical techniques. In the earliest phase clinical trials, treatments or new techniques that have been proven in a laboratory setting, are evaluated in humans for safety and side effects. Researchers also investigate dosing levels and how often a drug should be given as well as how it should be given—for example, whether by mouth or through an IV.

These types of trials also are called Phase I trials because they are the very first investigations to move from the lab and into actual patients. As research is gathered and therapies continue to be promising, clinical studies move to Phase II and Phase III trials before becoming widely available.

At Holden Comprehensive Cancer Center, we have a robust and rapidly growing Early Phase Cancer Clinical Trial Program. Here, early phase trials are open for a wide range of cancers in adults and children, including melanoma, sarcoma, breast, lung, genitourinary, and gynecologic cancers and both solid and soft tissue tumors.

The easiest answer is that by enrolling in these trials, you are truly at the leading edge of cancer research efforts. These clinical trials represent the first opportunity to evaluate some of the most exciting new cancer treatments. Among them are treatments that may benefit patients who have not responded previously to standard, already available cancer therapies.

While some of the drugs being evaluated in early phase trials may not progress to Phase II or III trials, information gathered will give us a better understanding of cancer and help in efforts to find better, more effective treatment options.

Clinical trials are a way to evaluate promising drugs, combinations of drugs, surgery techniques, or even new medical devices. They are designed to see if new advances in medical care are safe and effective in humans. There are risks involved in participating in any clinical trial. Risks may range from discomfort from a procedure, side effects from medication, or more serious medical concerns. However, the benefits of participating in a clinical trial outweigh the risks.

The benefit to participating may be that your clinical trial identifies a groundbreaking therapeutic option that stops your cancer from progressing further. Your participation will enhance our understanding of cancer and, over the long-term, might benefit future cancer patients as we and other researchers across the country and around the world continue to find better ways to treat cancer. Clinical trials are the way researchers and clinicians define future treatments.