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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 Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Cisplatin, Metronomic Low-Dose Interferon alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Cisplatin, Metronomic Low-Dose Interferon alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer Clinical research trials and Cisplatin, Metronomic Low-Dose Interferon alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Cisplatin, Metronomic Low-Dose Interferon alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer. Cisplatin, Metronomic Low-Dose Interferon alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Cisplatin, Metronomic Low-Dose Interferon alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer clinical trial. Participants frequently get the best healthcare available for their Cisplatin, Metronomic Low-Dose Interferon alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Cisplatin, Metronomic Low-Dose Interferon alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer  Cisplatin, Metronomic Low-Dose Interferon alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer
Cisplatin, Metronomic Low-Dose Interferon alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer
For Condition: recurrent pancreatic cancer,stage 3 pancreatic cancer,stage 4B pancreatic cancer,stage 2 pancreatic cancer,stage 4A pancreatic cancer
Status: Recruiting
Sponsor(s): University of Texas ,
Synopsis: 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: Phase II trial to study the effectiveness of combining cisplatin, gemcitabine, and metronomic low-dose interferon alfa with fever-range whole-body hyperthermia in treating patients who have inoperable or metastaticpancreatic cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JoanBull, Principal Investigator, University of Texas
University of Texas Health Science Center - Houston *Recruiting*
Houston, Texas, 77225
United States
Recruiting Joan Bull 713-500-6820
Additional Information:
Study ID Numbers: CDR0000360863; UTHSC-MS-02117
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082862
Other Recurrent Pancreatic Cancer Studies:
1. Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas
2. Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
3. Gemcitabine Plus Oxaliplatin in Treating Patients With Refractory Locally Advanced or Metastatic Pancreatic Cancer
4. UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
5. Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
Related Studies:
Other recurrent pancreatic cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
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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