Tuesday, Dec. 20, 2011
Trial at the John B. Amos Cancer Center tests new pancreatic cancer treatment
- kmccarthy@ledger-enquirer.comDr. Andrew Pippas, clinical oncology research director at John B. Amos Cancer Center is principle investigator for the state of Georgia for a current clinical drug trial regarding the treatment of pancreatic cancer.This trial is for previously untreated stage-4 pancreatic cancer patients. It will test whether adding a new drug, bavituximab, to the standard treatment of the disease improves quality and length of life.
Pippas said it’s his job, along with all other cancer doctors, to provide their patients with all the information that will allow them to make a rational decision about their treatment. He said doctors often recommend clinical drug trials, if the patient qualifies, because they believe it to be the best available cancer treatment.
“There are patients who still feel like any kind of clinical trial is experimentation,” said Pippas.
He said that patients don’t always understand the process of a clinical trial, which scares them into believing that participation could be an unsafe risk.
“There are patients who don’t understand that they are really protected on a clinical trial and there’s a whole group of by-laws and rules that the NIH (National Institutes of Health) set up to protect them,” he added.
Before a drug like bavituximab, the drug which is currently being tested, can be administered to human subjects, it must be tested for safety and efficacy in the laboratory and on animals, said FDA public affairs officer Pat El-Hinnawy.
“The FDA (Food and Drug Administration) would certainly not allow products on the market that are not safe or not effective,” said El-Hinnawy, regarding the importance and safety of clinical trials.
Promoting the bavituximab drug trial in the state of Georgia is the Georgia Center for Oncology Research and Education. Formed in 2003, Georgia CORE is a non-profit organization devoted to increasing access to new cancer treatments and more effective cancer care.
According to the organization’s literature, the availability of clinical trials in Georgia grew 41 percent between 2009 and 2010, due in large part to the network they’ve helped create throughout the state.
“Every new therapy, regardless of what cancer it (treats), started in a clinical trial,” said Nancy Paris, president and CEO of Georgia CORE.
The current standard treatment for pancreatic cancer is a drug called Gemzar, which has been shown to improve the quality of life for pancreatic cancer patients, but not length of life, said Pippas.
In the bavituximab drug trial, participants will be randomly selected to receive either the standard treatment (Gemzar) or the standard treatment plus bavituximab. The patients and doctors will be aware of who is receiving which treatment and each patient’s progress will be monitored.
Bavituximab is considered a first-in-class treatment, which means that it treats cancer in a different way than other drugs. Bavituximab targets and attacks blood cells within the cancerous tumor, shrinking the tumor and hopefully increasing the efficacy of chemotherapy. In early stages of the disease, it could allow for a previously inoperable tumor to be surgically removed.
After three months of treatment, the patient would be evaluated to see the effect of the treatment on the disease.
“We would continue either until the disease went away completely or until they had evidence of progression or they had some issue going on,” said Pippas. “We would continue (treatment) indefinitely.”
TO PARTICIPATE
If you are a previously untreated stage-four pancreatic cancer patient and would like to participate in the current clinical drug trial, contact the John B. Amos Cancer Center at 706-320-8700. Press option 5 and ask for Nancy Price, the clinical research program manager.
WHAT TO CONSIDER BEFORE PARTICIPATING IN CLINICAL RESEARCH
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health-care team questions about it. Dr. Andrew Pippas is the principal investigator for a current pancreatic cancer clinical drug trial taking place at the John B. Amos Cancer Center, among four other locations in the state. Pippas said he tries to provide patients with as much information about clinical trials as possible so they can make the best decisions about their treatment options.
Here are some questions from The Center for Information & Study on Clinical Research Participation (CISCRP) that patients should consider asking before participating in a study:
• What is the purpose of the study?
• Who is going to be in the study?
• Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
• What kinds of tests and treatments are involved?
• How do the possible risks, side effects, and benefits in the study compare with my current treatment?
• How might this trial affect my daily life?
• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow up care is part of this study?
• How will I know that the treatment is working? Will results of the trials be provided to me?
• Who will be in charge of my care?
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