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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

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon alfa
cisplatin
gemcitabine hydrochloride
hyperthermia treatment
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Health Science Center at HoustonRecruiting

Outcomes

Primary Outcome Measures

Tumor response
Toxicity
Survival
Changes in quality of life

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2004
Last Updated
February 10, 2012
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT00082862
Brief Title
Cisplatin, Metronomic Low-Dose Interferon Alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2002 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Procedure
Intervention Name(s)
hyperthermia treatment
Primary Outcome Measure Information:
Title
Tumor response
Title
Toxicity
Title
Survival
Title
Changes in quality of life
Secondary Outcome Measure Information:
Title
Conversion of inoperable tumors to operable
Title
Changes in cellular and cytokine immune function

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan M.C. Bull, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - University of Texas Health Science Ce
Phone
713-500-9500

12. IPD Sharing Statement

Citations:
PubMed Identifier
18608594
Citation
Bull JM, Scott GL, Strebel FR, Nagle VL, Oliver D, Redwine M, Rowe RW, Ahn CW, Koch SM. 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. 2008 Dec;24(8):649-62. doi: 10.1080/02656730802104740.
Results Reference
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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

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