5/3/98

Chemotherapy drug trials `showing promise'

By Genna McLaughlin

TRIBUNE-REVIEW

When he turned 57 in March, Robert Burke couldn't help remembering the prognosis doctors gave him last September of six months to live - and smiling.

"I'm still here" was the Hempfield Township man's recurring thought that day.

Despite his 4 1/2-year battle with advanced colorectal cancer that has traveled to his liver, Burke looks healthy as the nurses administer his chemotherapy at Dr. Terry Evans' hematology/oncology office in Greensburg.

A clinical trial drug, not yet approved by the Food and Drug Administration, drips from a bag into a tube in his chest during one of his weekly treatments.

So far, the oxaliplatin has been successful for Burke - shrinking and in some cases eliminating the tumors on his liver and surrounding his bile duct.

Burke is one of 14 colorectal cancer patients throughout western Pennsylvania participating in the University of Pittsburgh Cancer Institute trial. Researchers are testing how oxaliplatin is best administered when used in combination with two other approved chemotherapy drugs: 5-fluorouracil and leucovorin. Oxaliplatin is a platinum derivative (similar to the commonly used chemotherapy drug cisplatin) that attacks the genetic makeup of cancer cells. The trial, sponsored by Sanofi health care company, is being conducted at 15 centers in the United States and Canada.

"It's scary," Burke said of starting the drug that carried a long list of possible side effects . Despite the possibilities - even death - he refused to run away from a chance at a longer life.

"When they give these terminal dates, what do you have to lose?" said Burke.

Evans told Burke about the drug in November and he soon began treatments at Evans' office, one of the cancer institute's satellites.

For Burke, the outcome has been "marvelous."

But not everyone is willing to take risks with clinical trials. Only 2 percent to 3 percent of cancer patients nationwide participate in clinical trials, according to the cancer institute.

"Some patients look at these clinical trials and think we're asking them to be guinea pigs," said Evans. "Clinical trials are the only way we make progress in cancer treatment."

Many of today's cancer treatments are the result of yesterday's trials. In the mid-1980s a clinical trial replaced a radical mastectomy with a lumpectomy for treatment of breast cancer. According to Evans, a lumpectomy, which removes the cancerous lump rather than the entire breast, is much less traumatic.

But a drug not yet approved by the FDA can be "scary" for some patients, said Vicki Beaufort, clinical research coordinator at Evans' office.

"People are scared of them," she said. The thick trial book explaining the requirements to participate in the trial, possible side effects and exact treatments is intimidating. "It's a scary document."

For Burke, nothing could have been worse than the prognosis of six months to live.

"At that point, how could you be nervous? When doctors are giving you weeks or months, what else can you do?" said the retired U.S. Postal Service worker.

Burke has been one of the lucky ones who has "never felt sick" since he was diagnosed with colon cancer in November 1993. A sensitivity to cold and an unusual taste in his mouth are the only discomforts he's experienced from the trial chemotherapy.

But Burke knows that, despite his healthy demeanor, the cancerous tumors in his body are deadly.

It is estimated 55,000 people in the United States will die of colorectal cancer this year.

Advanced forms of the disease are often resistant to chemotherapy, according to Dr. Ramesh Ramanathan, principal investigator of the UPCI study and a professor of medical oncology at the University of Pittsburgh Medical Center. Oxaliplatin won't cure colorectal cancer but could possibly "prolong survival" and improve the quality of life.

"It shows promise," said Ramanathan, adding Burke is not the only patient whose tumors have responded positively to the drug. "Compared with standard therapy, the oxaliplatin/5-fluorouracil/leucovorin combination has shown higher response rates in patients with untreated advanced colorectal cancer."

Before it can be approved for widespread use, the drug must go through another trial phase - comparing it to current treatment methods.

Ramanathan predicts FDA approval is three or four years away.

On the day of Burke's first MRI after the trial began - when he learned the tumors had shrunk - he and his wife, Donna, celebrated. He holds on to the hope that "the longer I live, maybe they'll find a cure."

Thursday, he took his final trial dose of oxaliplatin. It will be up to the drug company if they will continue to provide him with the drug now that the trial is over.

"I don't have much of a say," said Burke, devoid of anger. "If the drug company says I don't, then I don't."

Regardless, the way Burke sees it, he's helped others who suffer from colorectal cancer.

"Maybe Mr. Burke and oxaliplatin will become the standard treatment for colorectal cancer," said Evans.

T. Gombar photos