Calcitriol and Docetaxel in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00238199|
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : April 24, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Dietary Supplement: calcitriol Drug: docetaxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Calcitriol-Enhanced Docetaxel in Patients With Previously Untreated Metastatic or Locally Advanced Pancreatic Cancer|
|Study Start Date :||June 2002|
|Primary Completion Date :||August 2006|
|Study Completion Date :||August 2006|
- Time to progression
- Median and one-year survival
- Overall response
- Change in pancreatic cancer-induced pain
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|