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| Descriptive Information Fields | |||||
| Brief Title † | Continuous Hyperthermic Peritoneal Perfusion With Cisplatin Plus Intraperitoneal Paclitaxel and Fluorouracil Following Surgery in Treating Patients With Peritoneal Cancer | ||||
| Official Title † | Phase II Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-Fluorouracil for Peritoneal Carcinomatosis | ||||
| Brief Summary | RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Peritoneal infusion of heated and nonheated chemotherapy drugs following surgery may kill more tumor cells. PURPOSE: This phase II trial is studying how well continuous hyperthermic peritoneal perfusion of cisplatin plus intraperitoneal infusions of paclitaxel and fluorouracil work in treating patients who have undergone surgery for peritoneal cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients are stratified according to histology (primary peritoneal mesothelioma vs low-grade mucinous adenocarcinoma [including low-grade mucinous neoplasms of borderline malignant potential] [closed to accrual as of 11/14/03] vs adenocarcinoma of gastrointestinal tract origin [other than low-grade mucinous, excluding pancreatic cancer]). Patients undergo cytoreductive surgery plus continuous hyperthermic peritoneal perfusion with cisplatin over 90 minutes on day 1 followed by intraperitoneal dwell chemotherapy with paclitaxel and fluorouracil over 60 minutes during the early postoperative period (days 7-12). Quality of life is assessed at study initiation, at 6 weeks, every 3 months for 1 year, and then every 6 months thereafter. Patients are followed at 4-6 weeks, every 3 months for 1 year, and then every 6 months for up to 4 years. PROJECTED ACCRUAL: A total of 179 patients (72 with peritoneal mesothelioma, 48 with low-grade mucinous adenocarcinoma [closed to accrual as of 11/14/03], and 59 with adenocarcinoma of gastrointestinal tract origin) will be accrued for this study within approximately 5-6 years. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Disease-free survival at 6 or 12 months [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Carcinoma of the Appendix Colorectal Cancer Peritoneal Cavity Cancer |
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| Intervention † | Drug: cisplatin Drug: fluorouracil Drug: paclitaxel Procedure: adjuvant therapy Procedure: conventional surgery Procedure: hyperthermia treatment |
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| MEDLINE PMIDs | 10197298, 10493628 | ||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 179 | ||||
| Start Date † | February 2000 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00020059 | ||||
| Organization ID | CDR0000067690 | ||||
| Secondary IDs †† | NCI-00-C-0069 | ||||
| Study Sponsor † | NCI - Center for Cancer Research-Medical Oncology | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | July 11, 2001 | ||||
| Last Updated Date | October 18, 2008 | ||||