At a glance
ClinicalIndex Comparison Record- ✓Histologically proven peritoneal carcinomatosis from primary peritoneal mesothelioma, low-grade mucinous adenocarcinoma/neoplasms, or gastrointestinal adenocarcinoma (excluding low-grade mucinous and pancreatic cancer)
- ✓Disease confined to peritoneal cavity on radiologic workup
- ✓Disease debulkable to residual tumor <1 cm per deposit on imaging or prior exploration
- ✓ECOG performance status ≤2
- ✕Concomitant medical problems placing patient at unacceptable risk for major surgery
- ✕Increased cardiac risk (age >65, hypertension, family history of CAD) with evidence of significant irreversible ischemia on stress thallium or ejection fraction <40%
- ✕Shortness of breath with minimal exertion and risk for pulmonary disease (e.g., chronic smokers) with FEV1 <1.2 liters or maximum voluntary ventilation <50% of expected
- ✕Baseline neurological toxicity Grade 3 or greater due to potential neurotoxicity of platinum and paclitaxel
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-Fluorouracil for Peritoneal Carcinomatosis
In Brief
A Phase 2 clinical trial evaluating Surgery, Continuous hyperthermic peritoneal perfusion (CHPP) with Cisplatin, and 1 other intervention for Abdominal Neoplasm and 3 related conditions. Completed, enrolled 188 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Patients will undergo cytoreductive 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.
Intraperitoneal dwell chemotherapy with a combination of 5-FU and Paclitaxel will be delivered in the early postoperative period (day 7 today 12 after surgery). Patients will be premedicated with hydrocortisone (100 mg/intravenous push (i.v.p.)), diphenhydramine (50 mg i.v.p.) and ranitidine (50 mg i.v.p.) 30 minutes prior to delivering intraperitoneal chemotherapy. One liter of normal saline will be infused containing 5-FU (800 mg/M\^2) and 1 L of normal saline containing paclitaxel (125 mg/M\^2) will be infused over 60 minutes. The chemotherapy solution will be left in the abdominal cavity permanently for slow absorption.