Pancreatic Cancer Clinical Trial
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
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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