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Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy
This study is currently recruiting patients.
Sponsored by: | National Cancer Institute (NCI) |
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Information provided by: | Warren G Magnuson Clinical Center (CC) |
Purpose
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.
Patients with peritoneal cancer whose tumor is confined to the abdomen may be eligible for this study. Candidates will be screened with a medical history and physical examination including blood tests, electrocardiogram, and possibly bone scan, brain magnetic resonance imaging, and chest, abdomen and pelvic CT scans. Those enrolled in the study will 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) will be 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) will then be delivered into the abdomen through one catheter and drained through another. After 90 minutes of bathing the abdomen with this solution, the drug will be rinsed from the abdomen and the catheters removed. Another small catheter will then be placed and left inside the abdomen with one end coming out through the skin. Two to 10 days after the operation, the drugs fluorouracil (5-FU) and paclitaxel will be given through this catheter.
After complete recovery from the surgery, the catheter will be removed and the patient discharged from the hospital. Clinic visits will be scheduled for periodic follow-up examination and tests.
Patients in this study will also be asked to assess how this therapy affects their general health and well being. This will require filling out two quality-of-life questionnaires before surgery and again at each follow-up visit after surgery. Each questionnaire takes about 15 minutes to complete.
Condition | Treatment or Intervention | Phase |
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Abdominal Neoplasm Colonic Neoplasm Mesothelioma Peritoneal Neoplasm |
Procedure: Surgical tumor excision Procedure: Abdominal perfusion Drug: Cisplatin Drug: 5-FU Drug: Paclitaxel |
Phase II |
MedlinePlus related topics: Asbestos; Cancer; Cancer Alternative Therapy; Colorectal Cancer; Digestive Diseases; Lung Cancer
Study Type: Interventional
Study Design: Treatment, Safety/Efficacy
Official Title: Phase II Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-Fluorouracil for Peritoneal Carcinomatosis
Expected Total Enrollment: 169
Study start: January 28, 2000
Cytoreductive surgery plus aggressive combination intraperitoneal chemotherapy may significantly alter the natural history of peritoneal carcinomatosis. The purpose of this study is to examine the treatment results of continuous hyperthermic peritoneal perfusion with cisplatin plus early postoperative intraperitoneal dwell therapy with 5-FU and paclitaxel after cytoreductive surgery for peritoneal carcinomatosis. Results will be assessed by following the time to radiographic or clinical recurrence of disease and survival. Patients will be stratified for entry based on histology. This will include 3 cohorts: 1) peritoneal mesothelioma; 2) low grade mucinous adenocarcinoma (including low grade mucinous neoplasms of borderline malignant potential); and 3) adenocarcinoma of gastrointestinal origin (other than low grade mucinous).
Eligibility
Genders Eligible for Study: Both
Criteria
Location and Contact Information
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