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Sponsored by: |
The University of Texas Health Science Center, Houston |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082862 |
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.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Biological: recombinant interferon alfa Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: hyperthermia treatment |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Estimated Enrollment: | 48 |
Study Start Date: | July 2002 |
Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed pancreatic carcinoma
Measurable lesion by physical examination, CT scan, or MRI
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Adequate cardiovascular function as documented by the following:
Pulmonary
Complete pulmonary function studies with the following arterial blood gas values:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Texas | |
University of Texas Health Science Center at Houston | Recruiting |
Houston, Texas, United States, 77225 | |
Contact: Joan M.C. Bull, MD 713-500-6820 joan.m.bull@uth.tmc.edu |
Principal Investigator: | Joan M.C. Bull, MD | The University of Texas Health Science Center, Houston |
Responsible Party: | University of Texas Health Science Center at Houston ( Joan M.C. Bull ) |
Study ID Numbers: | CDR0000360863, UTHSC-MS-02117 |
Study First Received: | May 14, 2004 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00082862 History of Changes |
Health Authority: | Unspecified |
stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer stage IV pancreatic cancer |
Antimetabolites Interferon-alpha Anti-Infective Agents Interferon Type I, Recombinant Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Interferons Endocrine System Diseases Immunosuppressive Agents Angiogenesis Inhibitors Antiviral Agents |
Recurrence Fever Digestive System Diseases Radiation-Sensitizing Agents Cisplatin Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Gemcitabine Interferon Alfa-2a Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Interferon Type I, Recombinant Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Neoplasms by Site Cisplatin Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Gemcitabine |
Endocrine Gland Neoplasms Interferon-alpha Digestive System Neoplasms Growth Substances Interferons Endocrine System Diseases Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Pancreatic Diseases |