- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00082862
Cisplatin, Metronomic Low-Dose Interferon Alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer
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.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Texas
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Houston, Texas, United States, 77030
- Recruiting
- University of Texas Health Science Center at Houston
-
Contact:
- Clinical Trials Office - University of Texas Health Science Ce
- Phone Number: 713-500-9500
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Survival
|
Tumor response
|
Changes in quality of life
|
Secondary Outcome Measures
Outcome Measure |
---|
Conversion of inoperable tumors to operable
|
Changes in cellular and cytokine immune function
|
Collaborators and Investigators
Investigators
- Principal Investigator: Joan M.C. Bull, MD, The University of Texas Health Science Center, Houston
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Wounds and Injuries
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Body Temperature Changes
- Heat Stress Disorders
- Pancreatic Neoplasms
- Hyperthermia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Interferons
- Interferon-alpha
Other Study ID Numbers
- CDR0000360863
- UTHSC-MS-02117
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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