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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Cisplatin; Gemcitabine; Interferon-alpha; Interferons

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