Today’s experimental therapies may be tomorrow’s treatments.

The clinical research department at Sudbury Regional Hospital’s Regional Cancer Program has been conducting clinical trials since 1986.

The department has three clinical research nurses, four associates, one ethics/regulatory associate and one co-ordinator.

“We put on trial 80 to 100 patients per year and have approximately 25 trials open at any one time in a variety of disease sites and stages, ” said Mark Whissell, clinical research co-ordinator. “We always try to have an appropriate mix of trials open for our larger disease sites (breast, colorectal, prostate and lung).”

The scope of the trials ranges from smaller studies developed by the centre’s oncology team to large international multicentre trials sponsored by either the pharmaceutical industry or co-operative research groups like the National Cancer Institute of Canada
Clinical Trials Group, the Radiation Therapy Oncology Group and the Ontario Clinical Oncology Group.

Approval process

A local oncologist will act as a lead for a specific protocol or trial. An internal
approval process occurs to ensure the study can be performed both logistically and ethically. The protocol undergoes an ethical review by a research ethics committee.

When studies are completed and show positive results, approval of the treatment is sought through Health Canada’s Therapeutic Products Directorate, the Canadian Federal Authority that regulates and approves new pharmaceutical drugs and medical devices.

Phase II to phase IV clinical trials are underway for breast, lung, prostate, colorectal, gastric, head and neck cancers, as well as acute and chronic leukemias, melanoma and sarcoma. Clinical trials for all disease sites progress through all three phases, but will vary in the number of total patients participating.

For example, studies involving cancers that are less common, like melanoma or brain tumours, may include between 50 and 100 patients, whereas a trial involving more common cancers like colorectal, may include between 300 to 4,000 patients. These trials are usually part of larger international studies.

Most of the trials follow a format known as standard-of-care plus a placebo, or
standard-of-care plus the experimental treatment, whether it is radiation, the addition of a drug, or possibly changes to the way the drug was used in the past. In a typical trial, a patient will have a 50/50 chance of getting the new treatment. A placebo is used to ensure more accurate and objective data.

There are four different types of clinical trials: treatment, prevention, screening and quality of life trials.

Treatment trials

Treatment trials test new treatments like medication, approaches to surgery, radiation therapy or a combination of therapies.

“About 90 per cent of our trials are treatment-oriented trials, which have a built-in quality of life component,” Whissell said.

In addition to studying the drug’s effectiveness, researchers monitor the drug’s toxicities (side effects) and whether the patient’s quality of life is enhanced or worsened.
In Sudbury, 85 per cent of the trials are systemic. Whissell said this is due to fewer available trials for radiation.

An example of a successful treatment experiment is the MA-17 trial, a breast cancer research study for postmenopausal women. The drug Femara (letrozole tablets) was given to women as an extended adjuvant therapy after they completed five years of tamoxifen. Adjuvant therapy is treatment given to patients after surgical removal of a tumour where there is a risk of future tumour growth.

Results showed the drug Femara reduced the risk of breast cancer recurrence by 38 per cent, and reduced the chance of breast cancer spreading to other parts of the body by 39 per cent.

Prevention trials

Prevention trials test new approaches such as medicine, vitamins, minerals or other supplements that may lower the risk of developing a certain type of cancer or prevent it from coming back.

The centre is currently running a phase III international breast cancer prevention clinical trial called MAP 3 involving 4,500 healthy postmenopausal women who are at an increased risk for developing breast cancer. The premise of the study is to inhibit estrogen production, which is believed to play a key role in the development and growth of most types of breast cancer. One group will get an exemestane tablet and the other group will receive a placebo. Exemestane belongs to a class of drugs called aromatase inhibitors, which prevent the conversion of androgens to estrogen, the primary source of estrogen production in postmenopausal women.

Screening trials

Screening trials test methods to find cancer in its early stages of development. Whissell said a lot of the screening trials have now become accepted practices, such as the PSA (prostate-specific antigen) blood test, a simple test that checks the levels of a prostate-produced protein called PSA. Unusually high levels may indicate potential prostate cancer.

Quality of life trials explore ways to improve comfort and quality of life for cancer patients. The majority of these have now been incorporated into treatment trials.

The average study is open for patients for a period of one to two years. They are all voluntary and a patient can decide to come off the trial at any time. Patient follow-up can occur five or more years after a trial.

The Northeastern Ontario Regional Cancer Centre receives more than 2,500 new patients per year. Approximately 75 per cent receive radiation therapy, 65 per cent receive systemic treatment and about 35 per cent receive both.

Physicians inform newly diagnosed patients about the trials, each of which has eligibility requirements, mostly relating to the stage and type of cancer.

Whissell said most patients have had positive comments about the trials. Patients can access medications they may not be prescribed otherwise, and they receive more detailed care as they may be seen more often. On the downside, participation in a clinical trial requires extra visits, which may be a concern for patients who live a significant distance from Sudbury.

www.neorcc.on.ca
www.excelstudy.com