Calcitriol and Docetaxel in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT00238199
• Lead Sponsor: OHSU Knight Cancer Institute

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* Determine the time to progression in patients with metastatic or locally advanced pancreatic cancer treated with calcitriol and docetaxel.

Secondary

* 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 Timeline

• Study Start: 2002-06
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-13
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-22
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Time to progression

Secondary Outcome Measures

Name	Time	Method
Median and one-year survival
Toxicity
Overall response
Change in pancreatic cancer-induced pain

Trial Locations

Locations (1)

Oregon Health & Science University Cancer Institute; 🇺🇸 Portland, Oregon, United States