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

Conditions:Cancer, Cancer, Infectious Disease, Pancreatic Cancer
Therapuetic Areas:Immunology / Infectious Diseases, Oncology
Age Range:18 - Any
Start Date:July 2002

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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

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.



- Determine tumor response in patients with inoperable or metastatic pancreatic cancer
treated with cisplatin, metronomic low-dose interferon alfa, gemcitabine, and
fever-range whole-body hyperthermia.

- Determine the toxicity of this regimen in these patients.

- Determine the survival of patients treated with this regimen.

- Determine changes in quality of life in patients treated with this regimen.


- Determine whether inoperable tumors convert to operable in patients treated with this

- Determine changes in cellular and cytokine immune function in patients treated with
this regimen.

OUTLINE: Patients are stratified according to disease stage (metastatic vs inoperable).

Patients receive cisplatin IV over 4-6 hours on day 1, interferon alfa subcutaneously once
daily on days 1-28, and gemcitabine IV over 1 hour on days 3 and 10. Patients undergo
fever-range whole-body hyperthermia (40°C over 6 hours) on day 3. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then before each treatment course.

PROJECTED ACCRUAL: A total of 18-48 patients (9-24 per stratum) will be accrued for this
study within 4 years.


- 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



- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- At least 12 weeks


- 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


- Bilirubin ≤ 2.5 mg/dL

- SGPT and SGOT ≤ 2 times upper limit of normal

- PT < 14 seconds

- PTT < 35 seconds

- INR < 1.5


- Creatinine ≤ 1.8 mg/dL

- Creatinine clearance ≥ 45 mL/min

- Blood urea nitrogen ≤ 25 mg/dL


- 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


- 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


- 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


Biologic therapy

- Prior biologic therapy allowed


- No prior cisplatin or gemcitabine

Endocrine therapy

- No concurrent adrenal corticosteroids


- More than 3 weeks since prior radiotherapy


- More than 6 days since prior major thoracic or abdominal surgery

- Prior surgical resection of tumor with subsequent recurrence allowed


- No concurrent cardiac glycosides

- No concurrent anti-angina or arrhythmia drugs

- No concurrent thrombolytic agents

- No concurrent anticoagulants

- No concurrent aspirin
We found this trial at
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
Houston, TX
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