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Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis Clinical research trials and Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis. Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis clinical trial. Subjects frequently get the best healthcare possible for their Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis
Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis
For Condition: Carcinoma,Peritoneal Neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Two days prior to planned surgery, paclitaxel is infused IV over 24 hours. Patients will undergo cytoreductive surgery, to debulk tumor. Scope of procedure will vary with each patient, including a spectrum of possible procedures, such as splenectomy, liver resection, pancreatic resection or bowel resection. After cytoreductive surgery, continuous hyperthermic peritoneal perfusion (CHPP) surgery with cisplatin will begin by placing an influx and efflux catheters via abdominal wall. Perfusion rate of cisplatin is 1.5 L/min and the duration is 90 min. Postoperative intraperitoneal chemotherapy will begin 24 hours after CHPP surgery. Dose escalation will proceed after patients at a given dose level receive 3 courses. In order to properly evaluate hematoxicity, a minimum of 3 weeks will be required before dose escalation. MTD is either the dose level immediately below the level at which 2 of 6 patients in a cohort experience nonhematologic dose limiting toxicity (DLT) or when 4 of 6 patients experience hematologic DLT. Two to 4 months after surgery, laparotomy will be conducted to determine response to treatment. If tumor size is decreased, patients will undergo a second treatment course identical to the same techniques and chemotherapy agents.
Details: Peritoneal carcinomatosis is considered a terminal stage of tumor progression. Cytoreductive surgery plus aggressive combination intraperitoneal chemotherapy may significantly alter the natural history of this disease. This study will define the maximum tolerated dose of paclitaxel and 5-fluorouracil (5-FU) given as an early post-operative intraperitoneal (IP) dwell therapy after cytoreductive surgery and continuous hyperthermic peritoneal perfusion with cisplatin (CHPP).
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: The patients must have an ECOG performance status of 0 or 1 and have no concomitant medical problems that would place them at increased risk for a major surgical procedure (EG, cardiac or pulmonary disabilities). Patients at increased risk for coronary artery disease or cardiac dysfunction (e.g., age greater than 65, history of hypertension, first degree relative with atherosclerotic coronary artery disease) will undergo cardiac evaluation and performed which will include an attempt to remove all disease greater than 0.5 cm in diameter.
Total Enrollment: 74
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 970072; 97-C-0072
Study Start Date: January 30, 1997
Record last reviewed: December 14, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001569
Other Peritoneal Neoplasm Studies:
1. Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis
2. SU5416 and Carboplatin to Treat Ovarian Cancer
3. Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy
4. A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Related Studies:
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Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis
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