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
- 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.
- Determine whether inoperable tumors convert to operable in patients treated with this
- Determine changes in cellular and cytokine immune function in patients treated with
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
Joan M.C. Bull, MD
The University of Texas Health Science Center, Houston
|University of Texas Health Science Center at Houston||Houston, Texas 77225|