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Patient at University of Colorado Cancer Center Grateful for Participation in Clinical Trial

From 2002 to 2007, 700 patients from 230 institutions participated in a Phase III clinical trial testing how well a daily pill of imatinib mesylate, better known as Gleevec, might keep rare gastrointestinal stromal tumors (GISTs) from roaring back in patients who had had them surgically removed.

Paula Hokanson of Tucson, Arizona was among 18 patients participating in the University of Colorado Cancer Center’s corner of the study.

Running out of treatment options

As the Christmas holidays approached in 2002, Hokanson, then 65, had run out of options. A month before, just after Thanksgiving, surgeons had removed from her abdomen a three-pound tumor the size of a football – a GIST. Typically GISTs resist standard chemotherapy and tend to grow back, so the standard of care was to watch and wait.

Clinical trial patient Paula Hokanson with budding
amaryllis in her Tucson backyard.

But neither Hokanson nor her family wanted to do that. One of Hokanson's daughters found the GIST study on www.clinicaltrials.gov. Hokanson called someone at Memorial Sloan-Kettering, one of the institutions taking part in the study, and was then put in contact with Martin McCarter, MD, associate professor of GI, Tumor and Endocrine Surgery at University of Colorado Denver's School of Medicine. McCarter deemed Hokanson eligible for the GIST study.

A pill per day

In early January 2003 Hokanson and her husband drove the 900 miles north to Denver, where they stayed in the metro-area home of cousins who were wintering in warmer climes. The Hokansons stayed there for two months. Paula took one pill per day and visited with McCarter once a week.

As McCarter explains, the Gleevec blocks a particular molecule binding site which normally stimulates growth of GISTs and other cells. In Hokanson's case, the drug also made her tired, triggered rashes, thinned her hair, made her muscles sore, dropped her white cell count, and puffed up her eyes.

But good news accompanied the unwelcome side effects: McCarter found that the tumor wasn't coming back.

A recurrence part of long-term management

When the two months were over, Hokanson and her husband drove back to Tucson. The monthly visits with McCarter continued, but Hokanson flew in just for the day, and as months turned to years, the flights became less frequent.

The Gleevec study required patients to take the drug for a year and be observed for four years after that. Hokanson stopped taking the drug in early 2004, and was counted among the successes.

However, the tumor reappeared in 2006. Hokanson left the clinical trial and took Gleevec again, and then switched to another drug, sunitinib malate (Sutent), on the advice of her Tucson oncologist. As of January 2009 the tumor had shrunk somewhat; Hokanson is awaiting results of a more recent assessment.

Such recurrences turned out to be common in the study, McCarter reports. "For many of these folks, stable disease is what we're going for – that the cancer stops growing or spreading elsewhere is a victory in itself."

Hokanson doesn't consider the recurrence a setback so much as a normal part of a long-term effort to manage her disease.

"When I look back at all of it I feel so blessed to have been able to participate in the trial and for all the great care I received [at the Cancer Center]," she says. "The study just turned my life around. I'm just grateful for every day I have."

 


 

This page is adapted from a story written by Todd Neff that appeared in the UCH Insider, the hospital's candid e-newsletter. The Insider, which is published biweekly, is available to people outside the hospital via a free e-mail subscription. Tyler Smith (tyler.smith@uch.edu) is managing editor of the Insider.

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