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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. Identifier: NCT00238199
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : April 24, 2015
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Dietary Supplement: calcitriol Drug: docetaxel Phase 2

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2002
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Time to progression

Secondary Outcome Measures :
  1. Median and one-year survival
  2. Overall response
  3. Toxicity
  4. Change in pancreatic cancer-induced pain

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of pancreatic cancer

    • Locally advanced or metastatic disease



  • Over 18

Performance status

  • Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

  • 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


Biologic therapy

  • Not specified


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

    • Other prior adjuvant chemotherapy allowed

Endocrine therapy

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00238199

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United States, Oregon
Oregon Health & Science University Cancer Institute
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
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Principal Investigator: Charles D. Blanke, MD, FACP OHSU Knight Cancer Institute

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Responsible Party: Charles Blanke, Oregon Health and Science University Knight Cancer Institute Identifier: NCT00238199     History of Changes
Other Study ID Numbers: CDR0000445077
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015
Keywords provided by OHSU Knight Cancer Institute:
stage III pancreatic cancer
stage IV pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents