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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|ClinicalTrials.gov Identifier: NCT00001569|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma Peritoneal Neoplasm||Drug: Cisplatin Drug: Paclitaxel Drug: 5-FU||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Official Title:||Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis|
|Study Start Date :||January 1997|
|Estimated Study Completion Date :||December 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001569
|United States, Maryland|
|National Cancer Institute (NCI)|
|Bethesda, Maryland, United States, 20892|