Calcitriol And Docetaxel In Treating Patients With Metastatic Or Locally Advanced Pancreatic Cancer

Study Overview

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.

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.

Pancreatic Cancer

DIETARY_SUPPLEMENT: calcitriol
DRUG: docetaxel

CDR0000445077
OHSU-GIM-02007-L
OHSU-1104

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2005-10-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-04-22
First Submitted that Met QC Criteria 2005-10-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-04-24
First Posted (ESTIMATED) 2005-10-13	Results First Posted N/A	Last Verified 2015-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Time to progression

Secondary Outcome Measures	Measure Description	Time Frame
Median and one-year survival
Overall response
Toxicity
Change in pancreatic cancer-induced pain

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Diagnosis of pancreatic cancer

Locally advanced or metastatic disease

Over 18

Eastern Cooperative Oncology Group (ECOG) 0-2

Not specified

White blood cell (WBC) > 3,000/mm^3
Absolute neutrophil count > 1,500/mm^3
Platelet count > 100,000/mm^3
Hemoglobin ≥ 8.0 g/dL (transfusion allowed)

Bilirubin < 1.5 times upper limit of normal (ULN)
Alkaline phosphatase (AP) < 5.0 times ULN
Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 2.5 times ULN (if AP < 2.5 times ULN) OR
ALT and AST < 1.5 times ULN (if AP > 2.5 times ULN and < 5.0 times ULN)

Creatinine < 1.3 mg/dL
Calcium < 10.5 mg/dL
Phosphate < 4.7 mg/dL
No kidney stones within the past 5 years
No history of hypercalcemia

No myocardial infarction within the past 3 months
No uncontrolled heart failure with a known ejection fraction < 30%
No other significant heart disease

Not pregnant or nursing
Fertile patients must use effective contraception
No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
No peripheral neuropathy ≥ grade 2
No comorbid condition that would preclude study participation

Not specified

No prior chemotherapy for metastatic disease
No prior chemoradiotherapy for locally advanced disease
No prior adjuvant docetaxel

Other prior adjuvant chemotherapy allowed

Not specified

See Chemotherapy
More than 2 weeks since prior radiotherapy

More than 30 days since prior investigational surgery

More than 7 days since prior and no concurrent digoxin or thiazide diuretic therapy
More than 30 days since prior investigational therapy
No concurrent magnesium-containing antacids, bile resin-binding drugs, or calcium supplements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sanofi

Investigators

PRINCIPAL_INVESTIGATOR: Charles D. Blanke, MD, FACP, OHSU Knight Cancer Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record