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Continuous Hyperthermic Peritoneal Perfusion With Cisplatin Plus Intraperitoneal Paclitaxel and Fluorouracil Following Surgery in Treating Patients With Peritoneal Cancer

This study is ongoing, but not recruiting participants.
Study NCT00020059.   Last updated on October 18, 2008.   Information provided by National Cancer Institute (NCI)

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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.

Detailed Description

OBJECTIVES:

  • Determine response and survival of patients with peritoneal carcinomatosis treated with continuous hyperthermic peritoneal perfusion with cisplatin and early postoperative intraperitoneal dwell therapy with fluorouracil and paclitaxel.
  • Determine the pharmacokinetics of paclitaxel and fluorouracil administered into the peritoneal cavity in these patients.
  • Assess the quality of life of patients treated with this regimen.

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.

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
Intervention  Drug: cisplatin
Drug: fluorouracil
Drug: paclitaxel
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: hyperthermia treatment
MEDLINE PMIDs 10197298,   10493628
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  179
Start Date  February 2000
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Histologically confirmed peritoneal carcinomatosis with the following histologies:

    • Primary peritoneal mesothelioma
    • Low-grade mucinous adenocarcinoma (including low-grade mucinous neoplasms of borderline malignant potential) (closed to accrual as of 11/14/03)
    • Adenocarcinoma of gastrointestinal tract origin (other than low-grade mucinous, excluding pancreatic cancer)
  • Confined to peritoneal cavity
  • Able to be debulked to residual size of less than 1 cm in diameter per tumor deposit
  • Must not have failed prior intraperitoneal platinum therapy

    • Treatment failure is defined as radiographic evidence of disease progression on 2 consecutive CT scans within 6 months after therapy

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 8 weeks

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 75,000/mm^3

Hepatic:

  • Bilirubin no greater than 3 times upper limit of normal (ULN)
  • AST and ALT no greater than 5 times ULN
  • Liver enzymes no greater than 2 times ULN

Renal:

  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 70 mL/min

Cardiovascular:

  • No significant irreversible cardiac ischemia
  • Ejection fraction at least 40%

Pulmonary:

  • FEV_1 at least 1.2 liters
  • Maximum voluntary ventilation at least 50% expected

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Weight at least 30 kg
  • No concurrent medical problems that would preclude surgery
  • No neurological toxicity of grade 3 or greater

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 30 days since prior immunotherapy and recovered

Chemotherapy:

  • See Disease Characteristics
  • At least 30 days since prior chemotherapy and recovered

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 30 days since prior radiotherapy and recovered

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent therapies
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 
Principal Investigator:     Marybeth S. Hughes, MD     NCI - Surgery Branch    
Information Provided By National Cancer Institute (NCI)
Verification Date April 2008
First Received Date  July 11, 2001
Last Updated Date October 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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