Clinical trial NCT00082862 (phase 2, status: unknown status)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: cisplatin, gemcitabine hydrochloride
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
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