An ongoing clinical trial at the University’s Cancer Center is studying the effects of an experimental new cancer drug that researchers hope will prolong the life of patients.
The trial is available only to patients with metastatic colorectal cancer, or cancer that has spread to other parts of the body.
Colorectal cancer, which is cancer that affects either the colon or the rectum, is the third most common and second most lethal form of cancer. If treated early, however, it can be one of the most curable forms.
Researchers combine the new drug with standard chemotherapies to test its ability to prevent tumors from creating their own blood supply in the body. If a tumor can’t do so, its growth might be slowed or stopped.
The study tracks patients until they die or until researchers have enough data to support a conclusion.
Metastatic disease patients survive only an average of 12 months. When the cancer doesn’t spread, doctors say two-thirds of the cases can be cured.
University researchers plan to study 20 to 25 of the 700 patients the national trial hopes to attract.
The drug, named SU5416, was created by SUGEN Inc., a subsidiary of Pharmacia & Upjohn. It is one of a new class of drugs coming out called anti-angiogenesis drugs.
Angiogenesis is the process by which tumors create their own blood supply though the formation of blood vessels. This drug, which will block the receptors on blood vessels that tumor cells bind to, might offer a way for doctors to stop or decrease tumor growth in patients where cancer has spread.
David Rothenberger, University professor in colon/rectal surgery and principal investigator in the study, said the goal of the study is to increase the life span of terminally ill patients.
“There are lots of ideas as to how to prevent metastasis, but right now we are just trying to see if we could use this drug to prolong the life of patients who have metastasis,” Rothenberger said.
“Everyone is excited about the potential, but now we need to do the hard work of clinical trials to find out if it really works,” he added.
Doctors often describe cancer in four stages. Stage A represents early stage disease. Stages B and C represent intermediary stages. Treatment at these stages involves curative surgery followed by chemotherapy to reduce the risk of recurrence. Stage D represents metastatic disease or the point at which the disease spreads.
Edward Greeno, assistant professor at Hennepin County Medical Center, is assisting in the trial. He said if the drug shows ability to prolong life in D-stage patients, studies would then be done to see if the drug could prevent spreading in patients in stages B and C.
“If this study were to be positive and show a survival advantage, we would then do additional studies in people who don’t yet have metastatic disease to see if it prevents recurrence,” Greeno said.
“That is something that would then be several years down the road after this study was completed.”
He added that while a survival advantage does not include a cure, it could include adding months on to the life of patients or creating a higher quality of life by reducing symptoms of the disease.
The Research Services Organization, a division of the Academic Health Center, provides assistance to investigators involved in these types of clinical trials.
Debra Dykhuis, associate program director, said the organization has provided a clinical research coordinator to assist with the collection of the data in this study as well as helping get the message out to prospective participants around the state.
“It does offer a novel experimental therapy for people who really don’t have anywhere else to go now with their disease,” she said. “There aren’t a lot of options left for trying something new for them. It’s really a reason to be hopeful, and something that we’re excited to be able to be a part of.”
Justin Costley covers the Medical School and welcomes comments at [email protected]. He can also be reached at (612) 627-4070 x3224.