Status:
UNKNOWN
Cisplatin, Metronomic Low-Dose Interferon Alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 met...
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 w...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00082862
Start Date
July 1 2002
Last Update
February 13 2012
Active Locations (1)
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1
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030