Clinical Trials Help Cancer Patients Today and in the Future

Scott Maul, M.D., Medical Hematology and Oncology

Posted: March 1, 2006

At Columbia St. Mary’s, some cancer patients participate in clinical trials to enhance their treatments and help advance medical research for their disease. Columbia St. Mary’s has the ability to participate in any National Cancer Institute trial through its many cooperative agreements. The unique studies are designed to determine if a new drug or treatment is effective and are a means to provide the best standards of care.

A clinical trial allows a patient to have access to extra care and additional hope for successful treatments. At Columbia St. Mary’s, we’re always looking for clinical trials that might result in the next generation of cancer treatments. Once we identify the appropriate trials, we assess our patients for their eligibility to be placed in a trial. Then we talk to those patients and discuss the possible benefits. There are no additional costs for them to participate.

Currently, there are over 20 clinical trials in various stages of progress. They range from trials designed to find the optimal treatment of cancer to trials designed to prevent cancer or reduce its symptoms. Over eight trials address the treatment of breast cancer alone, offering unique access to state-of-the-art therapy. For example, one current trial uses a drug called bevacizumab for the treatment of breast cancer. This medicine was shown to be highly effective in the treatment of metastatic colon and lung cancer and is very promising in the treatment of breast cancer.

Each trial offered at Columbia St. Mary’s ensures that patients receive treatment that is considered best standard of care while also adding promising new therapies that would not otherwise be available in the community. For patients, this means the chance to obtain cutting edge care right in their own neighborhood.

Clinical trial studies are often at the forefront of cancer treatments. In conducting the trials, Columbia St. Mary’s provides patients with additional treatment options that could include a promising, new investigational drug, or a treatment that could be as good, or better, than the accepted standard for the disease.

Most clinical research that involves the testing of a new drug will progress in an orderly series of steps so that reliable information is obtained and patients are protected. There are three different phases of clinical trials for cancer patients.

A Phase 1 trial is conducted to determine a safe and effective dose of a new medicine and to see what the maximum tolerated dose is before side effects become excessive. It determines if a new drug should be given by mouth, injected into the muscle or injected into the blood, and how often. This phase usually enrolls only a small number of patients. Once an appropriate dose is found, it goes to a Phase 2 trial.

A Phase 2 trial continues to ascertain the safety of the drug. The study places a limited number of patients on the medication and assesses the benefits of the drug. It usually focuses on a particular type of cancer. The therapies that seem to have a benefit will often go on to a Phase 3 trial.

Phase 3 trials are much larger studies. They’re often conducted across the country at various medical centers, doctors’ offices, clinics, and cancer centers, and can sometimes include thousands of patients. Some are even conducted internationally.

The Phase 3 trial tests a new drug, a new combination of drugs, or a new surgical procedure and compares it with the current standard therapy for a disease. A participant will usually be assigned to the standard group or the new group at random. The participants and the results are monitored to determine if the new medicine provides important benefits. If it does, it will often become the new standard.

The trials at Columbia St. Mary’s tend to be part of the larger Phase 3 trials of cancer treatments, which are designed and implemented by physicians who are thought leaders in their field. This phase provides an opportunity for a participating patient to potentially receive what may become the next new therapy for cancer before it becomes otherwise available.

Almost any patient with cancer feels that their diagnosis is a life-changing event. Many view the process of their treatment and education about their disease as a way to grow personally and find meaning. For some, a real sense of altruism results and they choose to participate in a clinical trial to help others. Participating in clinical trials not only provides the motivation of obtaining new treatments but also gives the satisfaction of advancing medicine and helping people who will be diagnosed with cancer in the future. It allows patients to have a purpose greater than their own.

Scott Maul, M.D.
Medical Hematology and Oncology
Columbia St. Mary’s
(414) 963-WELL

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