Trial Information

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

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