Doctors in the Brown University Oncology Group seek patients with gastrointestinal cancer who a want to participate in clinical trials involving novel anti-cancer agents. These trials are being conducted in Brown-affiliated hospitals and in Kent County Hospital.
The first drug tested will be Marimastat. It will be administered to patients who have already received a combined treatment of the drug paclitaxel and radiation therapy to reduce locally advanced and inoperable tumors in the pancreas.
Marimastat is not a chemotherapy drug. It is a new class of drugs called matrix-metalloproteinase inhibitors. Because this class of drugs does not cause cell death, Marimastat is not associated with the side effects commonly linked to chemotherapy. Studies show that matrix-metalloproteinase inhibitors may inhibit the ability of cancer cells to break down normal tissues and thus may prevent the growth of cancer cells. The drugs may also stop tumors from forming the blood vessels they need to thrive.
According to Howard Safran, M.D., lead investigator in the drug trials, Marimastat will be taken in soft gelcap form twice a day, following paclitaxel and radiation treatment, by patients with locally advanced pancreatic cancer.
In a second trial, Marimastat will be administered to patients who have undergone surgery to remove locally advanced cancer of the pancreas. This study will determine the drug's efficacy in preventing recurrence of pancreatic tumors.
Standard chemotherapy and radiation usually is not effective in preventing the regrowth of pancreatic cancer, said Safran, an assistant professor in the School of Medicine.
The third project will test a new class of potent antitumor antibiotics called duocarmycins. In this trial, a duocarmycin, dubbed KW2189, will be administered intravenously every six weeks to patients who have failed standard chemotherapy treatments for stomach cancer. The drug is considered a promising agent because it acts by a unique mechanism that seems different from standard chemotherapy, said Safran, who is based at Miriam Hospital and at Rhode Island Hospital.
The final trial will take place in conjunction with the Kimmel Cancer Center at Thomas Jefferson University in Philadelphia. It involves testing a combined treatment of pre-operative radiation and two chemotherapy drugs in patients with locally advanced rectal cancer. The drugs are 5-fluoruracil, which improves action of radiation to shrink or kill rectal tumors, and CPT-11, a new agent in the treatment of colon cancer. Effective use of radiation and chemotherapy before surgery for rectal cancer could greatly reduce the number of colostomies, or lower colon removals, performed each year, Safran said. About 55,000 cases of carcinoma of the rectum occur in the United States annually.
Patients interested in volunteering for the trials should contact their oncologist or call Safran at 331-8500, ext. 37979, or 444-4830.