Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy
Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
Summary
This study will test the effectiveness of an experimental treatment for peritoneal cancer
involving surgical removal of the tumor, perfusion of the abdomen during surgery with a
heated solution of the drug cisplatin, and post-surgery combination chemotherapy in the
abdomen with fluorouracil (5-FU) and paclitaxel.
Patients with certain peritoneal cancer whose tumors are confined to the abdomen may be
eligible for this study. Candidates are screened with a medical history and physical
examination, including blood tests, electrocardiogram and possibly bone scan, brain magnetic
resonance imaging (MRI), and chest, abdomen and pelvic CT scans.
Participants undergo surgery to remove as much tumor as possible. Part of the intestines,
pancreas, stomach or the entire spleen may also be removed if they are affected. During
surgery, after the tumor has been removed, two catheters (thin plastic tubes) are placed in
the abdomen. A chemotherapy solution containing the anti-cancer drug cisplatin heated to a
temperature of about 108.6 degrees (10 degrees above normal body temperature) is then
delivered into the abdomen through one catheter and drained through another. During
treatment, a drug called sodium thiosulfate is given through a vein to reduce the risk of
side effects of cisplatin, particularly kidney damage. After 90 minutes of bathing the
abdomen with this solution, the drug is rinsed from the abdomen and the catheters removed.
Another small catheter is then placed and left inside the abdomen with one end coming out
through the skin. Seven to 12 days after the operation, the anti-cancer drugs 5-FU and
paclitaxel are given through this catheter.
After complete recovery from the surgery, the catheter is removed and the patient is
discharged from the hospital. Clinic visits are scheduled for periodic follow-up examination,
imaging, and tests 3 and 6 months after surgery and every 6 months for up to 5 years as long
as the disease does not worsen. Patients whose disease progresses are taken off the study and
referred back to their local physician or referred for alternative care or other research
studies.
Patients are also asked to assess how this therapy affects their general health and well
being. This will require filling out two quality-of-life (QOL) questionnaires before surgery
and again at each follow-up visit after surgery. Each questionnaire takes about 15 minutes to
complete.