Mesothelioma Related Clinical Trials:
Cytoreductive Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy for the Treatment of Peritoneal Carcinomatosis From Gastrointestinal Cancer: an Open Label, Randomized, Prospective, Phase 2 Clinical Trial

• survival time
  
• time to treatment failure
  

• perioperative morbidity and mortality
  

DISEASE CHARACTERISTICS:

• Histologically confirmed peritoneal carcinomatosis with the following histologies:
• Primary peritoneal mesothelioma
• Adenocarcinoma of gastrointestinal tract origin
• Confined to peritoneal cavity
• Tumor mass could be debulked to less than 2.5 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 3 months after therapy

PATIENT CHARACTERISTICS:

Age:

- 20 to 70 years old

Performance status:

- KPS>50

Life expectancy:

- More than 8 weeks

Hematopoietic:

• WBC at least 3,500/mm^3
• Platelet count at least 80,000/mm^3

Hepatic:

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

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No significant irreversible cardiac ischemia
• No significant changes in ECG recording

Pulmonary:

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

Other:

• Not pregnant or nursing
• Negative pregnancy test
• No concurrent medical problems that would preclude surgery