Pancreatic Cancer | Cisplatin, Metronomic Low-Dose Interferon Alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer
Pancreatic Cancer research study
What is the primary objective of this study?
RATIONALE: Drugs used in chemotherapy, such as cisplatin and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving low-dose interferon alfa on a metronomic (regularly timed) schedule may stop the growth of cancer by stopping blood flow to the tumor. Fever-range (above 101° F) whole-body hyperthermia kills tumor cells by heating them to several degrees above normal body temperature. Combining cisplatin, gemcitabine, and low-dose interferon alfa with fever-range whole-body hyperthermia may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin, gemcitabine, and metronomic low-dose interferon alfa together with fever-range whole-body hyperthermia works in treating patients with inoperable or metastatic pancreatic cancer.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Biological:recombinant interferon alfa
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: July 2002
Phase: Phase 2
Primary Outcome: Tumor response
Secondary Outcome: Conversion of inoperable tumors to operable
Study sponsors, principal investigator, and references
Principal Investigator: Joan M.C. Bull, MD
Lead Sponsor: The University of Texas Health Science Center, Houston
Bull JM, Scott GL, Strebel FR, Nagle VL, Oliver D, Redwine M, Rowe RW, Ahn CW, Koch SM. Fever-range whole-body thermal therapy combined with cisplatin, gemcitabine, and daily interferon-alpha: a description of a phase I-II protocol. Int J Hyperthermia. 2008 Dec;24(8):649-62. doi: 10.1080/02656730802104740.