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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   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes

July 11, 2001
February 6, 2009
February 2000
 
Disease-free survival at 6 or 12 months [ Designated as safety issue: No ]
Disease-free survival at 6 or 12 months
Complete list of historical versions of study NCT00020059 on ClinicalTrials.gov Archive Site
 
 
 
Continuous Hyperthermic Peritoneal Perfusion With Cisplatin Plus Intraperitoneal Paclitaxel and Fluorouracil Following Surgery in Treating Patients With Peritoneal Cancer
Phase II Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-Fluorouracil for Peritoneal Carcinomatosis

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.

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.

Phase II
Interventional
Treatment, Open Label
  • Carcinoma of the Appendix
  • Colorectal Cancer
  • Peritoneal Cavity Cancer
  • Drug: cisplatin
  • Drug: fluorouracil
  • Drug: paclitaxel
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Procedure: hyperthermia treatment
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
179
 
 

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020059
 
CDR0000067690, NCI-00-C-0069
National Cancer Institute (NCI)
 
Principal Investigator: Marybeth S. Hughes, MD NCI - Surgery Branch
National Cancer Institute (NCI)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP