A current trial sponsored by Herbert Irving Comprehensive Cancer Center in partnership with the National Cancer Institute may lead to important breakthroughs in the area of mesothelioma treatment. The objectives of the Surgery, Chemotherapy and Radiation Therapy in Treating Patients With Peritoneal Cancer Clinical Trial taking place in New York City are to determine the response rate, duration of response and duration of survival of patients with peritoneal mesothelioma treated with surgery, intraperitoneal chemotherapy and whole abdominal radiotherapy. The secondary goal is to determine the toxicity of this regimen in patients.
The study, which was last updated on ClinicalTrials.gov on February 6, 2009, has an enrollment of 15 patients and began in May 2001. The trial is ongoing, but currently nor recruiting additional participants.
Peritoneal cancer affects the tissue lining the abdominal wall and the organs located in the abdomen. Exposure to airborne asbestos particles is the only known cause of peritoneal mesothelioma. Mesothelioma treatment typically involves surgery, chemotherapy, radiation or a combination of the three.
The mesothelioma doctors conducting this survey were looking for both men and women over the age of 18 who had historically confirmed malignant mesothelioma and a life expectancy of at least two months. Recruits were not allowed to have undergone more than two prior chemotherapy regimens and/or one prior intraperitoneal chemotherapy regimen. At least six weeks had to have passed since the initial chemotherapy treatments, and concurrent chemotherapy was not permitted during the study.
Patients were not included in the study if they had a bilirubin under 1.5 times normal, symptomatic cardiovascular disease or other heart problems, such as congestive heart failure or angina pectoris. Those with serious infection were excluded, as were those with malignancies within the five years prior to the study. Uncontrolled neurological diseases and seizure disorders were also factors for exclusion.
Patients who were pregnant or nursing were excluded, as were those with emotional instability. Fertile patients were expected to use proper contraceptive measures. For those recruits undergoing endocrine therapy, concurrent hormonal therapy was not allowed except for non-disease related conditions. For example, patients could continue use of insulin for diabetes.
Patients accepted into the trial underwent initial surgery and were observed by consulting oncologists, including Dr. Robert Taub. Three to four weeks after this surgery, they received intraperitoneal chemotherapy consisting of doxorubicin IP for two hours, once weekly for weeks 1, 4, 7 and 10. They received cisplatin IP and gemcitabine IP once weekly during weeks 2, 5, 8 and 11. They also received interferon gamma IP once weekly during weeks 13-16.
At week 18-20, patients underwent a second-look surgery. Those with no gross disease received hyperthermia mitomycin IP and Cisplatin IP for a duration of 90 minutes. Two to four weeks after second-look surgery, patients underwent radiotherapy 5 times a week for 5-7 weeks. In the absence of disease progression or unacceptable toxicity, treatment continues.
Additional information can be found by visiting the trial’s information page. The Mesothelioma and Asbestos Awareness Center encourages mesothelioma patients, their families, and their treatment team to consider relevant clinical trials. Your oncologist will be able to determine whether or not you are healthy enough to undergo participation in a certain trial.
