Cisplatin, Metronomic Low-Dose Interferon Alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed pancreatic carcinoma
• Inoperable or metastatic disease
• Measurable lesion by physical examination, CT scan, or MRI
• Carcinomatous hepatomegaly is considered measurable if a palpable liver edge clearly extends > 15 cm below the costal margin or xiphoid process
• No known brain metastases by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute granulocyte count ≥ 1,500/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Hemoglobin > 10.0 g/dL
• Platelet count ≥ 90,000/mm^3
• Bone marrow cellularity normal on bone marrow biopsy
• No serious coagulopathy disorder

Hepatic

• Bilirubin ≤ 2.5 mg/dL
• SGPT and SGOT ≤ 2 times upper limit of normal
• PT < 14 seconds
• PTT < 35 seconds
• INR < 1.5

Renal

• Creatinine ≤ 1.8 mg/dL
• Creatinine clearance ≥ 45 mL/min
• Blood urea nitrogen ≤ 25 mg/dL

Cardiovascular

• Adequate cardiovascular function as documented by the following:
• History and physical examination
• Stress exercise test (MUGA or echocardiogram) with resting blood pressure, heart rate, and LVEF that increase appropriately with exercise
• LVEF ≥ 45%
• No myocardial infarction within the past 6 months
• No symptomatic coronary artery disease
• No angina
• No unstable blood pressure
• No congestive heart failure
• No significant arrhythmia
• No conduction disturbance
• No thromboembolic disease
• No uncontrolled hypertension

Pulmonary

• Complete pulmonary function studies with the following arterial blood gas values:
• FEV_1 ≥ 70% of predicted
• Arterial PO_2 ≥ 60 mm Hg on room air
• PCO_2 appropriate
• pH appropriate
• No massive (≥ 30%) lung disease
• DLCO > 50% of predicted

Other

• No prior or concurrent seizures or other CNS disorders
• No prior malignant hyperthermia after general anesthesia
• No insulin-dependent diabetes mellitus
• No significant emotional instability
• No other medical problem that would preclude treatment with whole-body hyperthermia
• HIV negative
• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior biologic therapy allowed

Chemotherapy

• No prior cisplatin or gemcitabine

Endocrine therapy

• No concurrent adrenal corticosteroids

Radiotherapy

• More than 3 weeks since prior radiotherapy

Surgery

• More than 6 days since prior major thoracic or abdominal surgery
• Prior surgical resection of tumor with subsequent recurrence allowed

Other

• No concurrent cardiac glycosides
• No concurrent anti-angina or arrhythmia drugs
• No concurrent thrombolytic agents
• No concurrent anticoagulants
• No concurrent aspirin