Calcitriol and Docetaxel in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
RATIONALE: Calcitriol may cause pancreatic cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Calcitriol may also help docetaxel work better by making the tumor cells more sensitive to the drug. Giving calcitriol together with docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving calcitriol together with docetaxel works in treating patients with metastatic or locally advanced pancreatic cancer.
Dietary Supplement: calcitriol
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Calcitriol-Enhanced Docetaxel in Patients With Previously Untreated Metastatic or Locally Advanced Pancreatic Cancer|
- Time to progression [ Designated as safety issue: No ]
- Median and one-year survival [ Designated as safety issue: No ]
- Overall response [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Change in pancreatic cancer-induced pain [ Designated as safety issue: No ]
|Study Start Date:||June 2002|
|Study Completion Date:||August 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
- Determine the time to progression in patients with metastatic or locally advanced pancreatic cancer treated with calcitriol and docetaxel.
- Determine the median and one-year survival of patients treated with this regimen.
- Determine the overall response in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the change in pancreatic cancer-induced pain in patients treated with this regimen.
OUTLINE: Patients receive oral calcitriol on days 1, 8, and 15 and docetaxel IV over 15-30 minutes on days 2, 9, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238199
|United States, Oregon|
|Oregon Health & Science University Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|Principal Investigator:||Charles D. Blanke, MD, FACP||OHSU Knight Cancer Institute|