Cisplatin, Metronomic Low-Dose Interferon Alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer
Recruitment status was: Recruiting
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.
Biological: recombinant interferon alfa
Drug: gemcitabine hydrochloride
Procedure: hyperthermia treatment
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- Tumor response [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Survival [ Designated as safety issue: No ]
- Changes in quality of life [ Designated as safety issue: No ]
- Conversion of inoperable tumors to operable [ Designated as safety issue: No ]
- Changes in cellular and cytokine immune function [ Designated as safety issue: No ]
|Study Start Date:||July 2002|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082862
|United States, Texas|
|University of Texas Health Science Center at Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Joan M.C. Bull, MD||The University of Texas Health Science Center, Houston|