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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.
 
ClinicalTrials.gov Identifier: NCT00238199
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : April 24, 2015
Sponsor:
Collaborator:
Sanofi
Information provided by:
OHSU Knight Cancer Institute

Tracking Information
First Submitted Date  ICMJE October 12, 2005
First Posted Date  ICMJE October 13, 2005
Last Update Posted Date April 24, 2015
Study Start Date  ICMJE June 2002
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2007)
Time to progression
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00238199 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2007)
  • Median and one-year survival
  • Overall response
  • Toxicity
  • Change in pancreatic cancer-induced pain
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Calcitriol and Docetaxel in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
Official Title  ICMJE Phase II Study of Calcitriol-Enhanced Docetaxel in Patients With Previously Untreated Metastatic or Locally Advanced Pancreatic Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Dietary Supplement: calcitriol
  • Drug: docetaxel
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2009)
25
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Diagnosis of pancreatic cancer

    • Locally advanced or metastatic disease

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

  • Not specified

Hematopoietic

  • 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)

Hepatic

  • 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)

Renal

  • 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

Cardiovascular

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Radiotherapy

  • See Chemotherapy
  • More than 2 weeks since prior radiotherapy

Surgery

  • More than 30 days since prior investigational surgery

Other

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00238199
Other Study ID Numbers  ICMJE CDR0000445077
OHSU-GIM-02007-L
OHSU-1104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Charles Blanke, Oregon Health and Science University Knight Cancer Institute
Study Sponsor  ICMJE OHSU Knight Cancer Institute
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Principal Investigator: Charles D. Blanke, MD, FACP OHSU Knight Cancer Institute
PRS Account OHSU Knight Cancer Institute
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP