Clinical Trials Dependent on Participants

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http://www.reporterherald.com/news_story.asp?ID=17046

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Every evening after dinner, Rick Taylor swallows four large orange-brown pills, hoping they will be the silver bullets that kill the tumors ravaging his chest.

So far, his treatment seems to be working.

Taylor, a Longmont resident who has lung cancer, is participating in a clinical trial at Rocky Mountain Cancer Centers, Longmont, for Enzastaurin. The experimental drug might help prevent the growth of new blood vessels that feed tumors.

His treatment also includes standard chemotherapy drugs.

Some of his large tumors have shrunk in half since treatment began in March; smaller ones have disappeared.

“I couldn’t ask for anything better than those kind of results,” said Taylor, 47.

Taylor is in a minority of cancer patients who are willing to participate in clinical trials, according to medical experts. Nationally, only 2 percent to 4 percent of those eligible participate, said Dr. Anthony Elias, the medical director of the breast cancer and sarcoma programs at the University of Colorado Cancer Center in Denver.

It’s a difficult situation, because without a sufficient number of participants, the availability of new treatments could be delayed months or even years, Elias said.

Dr. Mark Barnett, an oncologist at Rocky Mountain Cancer Centers, Longmont, and Taylor’s oncologist, said he discusses clinical trials with most of his patients, but few sign up.

“There is still a reluctance for people to participate,” he said. “That’s something we are trying to overcome.”

Barnett said many common fears of clinical trials are unfounded because by the time the clinical trials get to stage II and stage III, they have been tested extensively. In fact, patients could receive a better outcome from experimental drugs, because clinical trials provide patients with access to the latest investigative treatments, he said.

“We’re trying to offer people a shot at therapy that may be better,” Barnett said. “All oncology is moving to a silver-bullet goal of just hitting the cancer, which is much less toxic for the patient.”

When Barnett was a medical student in 1996, the majority of patients suffering from chronic myeloid leukemia died.

Now because of clinical trials and subsequent approval of the drug Gleevec, the illness can be put in complete remission 95 percent of the time and without side effects, he said.

“It’s far more often that new treatments are in fact better than the old therapy,” Elias said. “If you look at the history of clinical trials along the way, it is clear that we are doing substantially better in current treatment than what we used to do.”

Those participating in clinical trials still receive the same standard of care as cancer patients who don’t participate in trials, Barnett said. For instance, Taylor also receives the same chemotherapy he would get without participating in the study — alternating doses of Carboplatin and Alimta.

In addition, there’s a strict protocol for clinical trials and doctors are more likely to administer clinical trials on time and at full dose, Elias said.

Elias said there are many obstacles stopping people from participating. For instance the consent forms are filled with possible side effects that are not connected to the drug, he said.

“Nobody in their right mind would read this stuff and say, ‘OK, sign me up,’” Elias said. “Ultimately, patients trust physicians not to lead them astray.”

That’s exactly what happened with Taylor. He asked Barnett what to do, and Barnett recommended the trial.

Taylor is feeling better. His chronic coughing is almost gone. He’s no longer out of breath when he walks.

“When I become a cancer survivor, my hope would be to be a role model to other people,” he said. “It’s the research that helps people. I (too) might benefit from the next pill that comes out.”

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(ReporterHerald.com, By Susan Glairon, Longmont Times-Call, May 27, 2008)

Disclaimer:

The information contained in these articles may or may not be in agreement with my own opinions. They are not posted as medical advice of any kind.