Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Other	UTHSC-MS-02117 NCT00082862

Objectives

Primary

1. 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.
2. Determine the toxicity of this regimen in these patients.
3. Determine the survival of patients treated with this regimen.
4. Determine changes in quality of life in patients treated with this regimen.

Secondary

1. Determine whether inoperable tumors convert to operable in patients treated with this regimen.
2. Determine changes in cellular and cytokine immune function in patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute granulocyte count ≥ 1,500/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Hemoglobin > 10.0 g/dL
• Platelet count ≥ 90,000/mm³
• 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:
  • FEV₁ ≥ 70% of predicted
  • Arterial PO₂ ≥ 60 mm Hg on room air
  • PCO₂ 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

Expected Enrollment

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

Outcomes

Tumor response
Toxicity
Survival
Changes in quality of life

Conversion of inoperable tumors to operable
Changes in cellular and cytokine immune function

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.

Bull JM, Scott GL, Strebel FR, et al.: 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 24 (8): 649-62, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

University of Texas Health Science Center at Houston

Joan Bull, MD, Principal investigator		Ph: 713-500-6820 Email: joan.m.bull@uth.tmc.edu

U.S.A.
Texas
	Houston
	University of Texas Health Science Center at Houston
		Joan Bull, MD	Ph:  713-500-6820
			Email: joan.m.bull@uth.tmc.edu

Registry Information
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
Trial Start Date		2002-07-19
Trial Completion Date		2012-11-01 (estimated)
Registered in ClinicalTrials.gov		NCT00082862
Date Submitted to PDQ		2004-03-03
Information Last Verified		2008-12-28

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