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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00082862
Recruitment Status : Unknown
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 19, 2004
Last Update Posted : February 13, 2012
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: recombinant interferon alfa Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: hyperthermia treatment Phase 2

Detailed Description:



  • 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 regimen.
  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2002
Estimated Primary Completion Date : November 2012

Primary Outcome Measures :
  1. Tumor response
  2. Toxicity
  3. Survival
  4. Changes in quality of life

Secondary Outcome Measures :
  1. Conversion of inoperable tumors to operable
  2. Changes in cellular and cytokine immune function

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00082862

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United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Trials Office - University of Texas Health Science Ce    713-500-9500      
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
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Principal Investigator: Joan M.C. Bull, MD The University of Texas Health Science Center, Houston
Publications of Results:
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Responsible Party: Joan M.C. Bull, University of Texas Health Science Center at Houston Identifier: NCT00082862    
Other Study ID Numbers: CDR0000360863
First Posted: May 19, 2004    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: December 2008
Keywords provided by National Cancer Institute (NCI):
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
stage IV pancreatic cancer
Additional relevant MeSH terms:
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Body Temperature Changes
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs