A Phase II Clinical Trial of a Timing/Schedule Optimized Combined-Modality Regimen: Cisplatin + Metronomic Low-Dose Interferon-α (IFN-α) Followed by Gemcitabine HCl (GEMZAR) in Combination With Mild, Fever-Range Whole-Body Hyperthermia (FR-WBH) in Patients With Advanced, Inoperable Pancreatic Cancer

Inclusion Criteria

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