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Local doctor is part of study

January 7, 2008 12:35 am

BY JIM HALL

As part of their chemotherapy treatments, many colon cancer patients receive a cocktail of three drugs: leucovorin, oxaliplatin and 5-FU.

But what if a fourth drug, bevacizumab, was added to the mix?

Bevacizumab stops tumor growth by preventing the formation of new blood vessels. Would it help colon cancer patients?

That question is being asked and answered now in hospitals and doctors' offices across the country, including one in Fredericksburg. Dr. Frederick C. Tucker Jr. has joined a National Cancer Institute study that adds bevacizumab to the traditional regimen for colon cancer patients.

The study is part of a program that moves clinical studies from large academic centers into smaller community settings. Tucker, an oncologist, is hosting 22 NCI-sponsored clinical trials. He is one of more than 3,300 doctors nationwide taking part in the federal agency's Community-Clinical Oncology Program.

Tucker joined the 24-year-old program in May, believing that local patients want to participate in major cancer trials and prefer to stay close to home to do it.

"Now patients don't have to travel to Baltimore or Charlottesville to get access to those trials," Tucker said.

So far about 15 patients have enrolled in the trials. Delores Arrington was one of them.

Arrington, a 45-year-old resident of Fredericksburg, was diagnosed with breast cancer in June and had a double mastectomy at Mary Washington Hospital in July.

From September through November she received chemotherapy in Tucker's office as a subject in one of the NCI studies. She will begin radiation treatments soon.

Arrington's chemo trial is called CALGB-4101. It divides women with breast cancer into two groups. Both groups receive cyclophosphamide and doxorubicin. One of the groups also receives a third drug, paclitaxel.

"That's very typical of these trials: the standard and the standard plus some modification." Tucker said.

The women receive the drugs for up to three months and are checked regularly to see how they do.

Arrington was a nursing assistant at Mary Washington Hospital until she was diagnosed with cancer.

She said she participated in the clinical trial in hopes of receiving state-of-the-art treatment, but also to advance medical knowledge.

"We have daughters, and we have sons," she said. "I have brothers and sisters and so does my husband. Working in the medical field, why wouldn't you want to help the future."

Tucker is hosting trials for eight types of cancer, from melanomas to lung cancer.

"It's the kind of clinical problems we see day in and day out," he said. "We're trying to find improved medicines or improved ways of giving what we already have."

Most of the trials are Phase III trials, meaning that the study drugs have already shown promise in earlier trials. Phase III trials usually last for several years and involve large numbers of patients. An individual patient would be enrolled during the time he or she receives treatments, usually two to four months.

Participation is voluntary. Patients are referred by their doctors and must meet the study criteria.

Patients are not paid to participate, but they are not charged if they receive study drugs. Most insurance plans pay for standard treatments, Tucker said. Tucker is paid by NCI to collect the data. He is not paid to recruit patients, he said.

The studies are in addition to the 16 clinical trials now under way at Mary Washington Hospital, where doctors are testing drugs and medical devices.

For example, Dr. Jeffrey Rehm, Dr. Robert Vranian and Dr. Jeffrey Askew are testing drugs that prevent blood clots to see if they work better than Coumadin, a popular blood thinner.

All of the trials at the hospital must be submitted to its "institutional review board," or IRB, a group headed by Dr. Rebecca Bigoney. Tucker's trials are reviewed by another IRB.

An IRB looks at a number of factors, Bigoney said, including whether the trial is potentially useful and well designed and whether patients are well informed.

"The job of an IRB is the protection of human subjects," Bigoney said.

Patients are exposed to some risk when they enroll in clinical trials, Bigoney said. The experimental drug they take may turn out to be more toxic or less effective than standard therapy. Or the new drug could be more effective and less toxic.

"You are putting yourself at risk in either group," Bigoney said. "The level of risk has to be acceptable."

Tucker believes the risks are acceptable. He also said that clinical trials are how doctors learn new and better ways to treat patients.

"It's evidence-based medicine," he said. "You have an idea or a drug, and you think it works better. The only way to show that is to do a clinical trial."

Jim Hall: 540/374-5433
Email: jhall@freelancestar.com