Cisplatin, Metronomic Low-Dose Interferon Alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage IV pancreatic cancer
Eligibility 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
Sites / Locations
- University of Texas Health Science Center at HoustonRecruiting