• Disease-free survival at 6 or 12 months [ Designated as safety issue: No ]
  

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.

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