Clinical trial developed at Massey tests novel combination of chemotherapy and radiation therapy for the treatment of pancreatic cancer
A phase 1 clinical trial developed at VCU Massey Cancer Center is testing a combination of targeted therapy with standard chemotherapy and radiation given prior to surgery in patients with non-metastatic pancreatic cancer. Surgery is often the most effective treatment for pancreatic cancer, but in many cases it is not possible if the tumor has spread to other parts of the digestive system or nearby organs. Neoadjuvant therapy, or therapy prior to surgery, can help shrink tumors and make them operable.
“Since this is a phase 1 trial, our primary objective is determining the appropriate dosage of the drugs in combination with the radiation therapy schedule,” says the trial’s principal investigator Andrew Poklepovic, M.D., medical oncologist and member of the Developmental Therapeutics research program at VCU Massey Cancer Center. “This regimen uses standard chemotherapy and radiation treatments as the basis of therapy, with newer, targeted chemotherapy agents given in addition to the standard treatment, with the hopes of increasing the effectiveness. We will be looking at the safety and toxicity of the treatment regimen, as well as its anti-tumor effects.”
The study will analyze several other factors in relation to the effectiveness of the combination therapy. It will evaluate the percentage of patients who are able to undergo surgery following neoadjuvant therapy, and it will examine cellular biomarkers in tumor samples from before and after treatment. In addition, the study will also evaluate progression-free survival and overall survival of trial participants.
To be eligible for the trial, patients must have non-metastatic pancreatic cancer, have sufficient liver and kidney function and be able to take oral medication.
Trial participants will first receive two months or more of standard chemotherapy already proven effective for pancreatic cancer. They will then start a six-week treatment course consisting of standard intravenous gemcitabine and radiation therapy with the addition of the oral study drugs sorafenib and vorinostat. Sorafenib is used to treat liver, kidney and thyroid cancers, while vorinostat is approved for use in cutaneous T-cell lymphoma. Preclinical research at Massey has shown that sorafenib and vorinostat can synergize to kill cancer cells.
“Research has shown that certain chemotherapy agents can increase the ability of radiation therapy to kill cancer,” says the trial’s co-investigator Emma Fields, M.D., radiation oncologist and member of the Developmental Therapeutics research program at Massey. “We are hopeful that the research we have seen in our labs will translate to the clinic and allow for better patient outcomes when combined with surgery.”
To enroll or receive more information about this study, please call the study nurse at (804) 628-5006 or email the study team at email@example.com.