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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00238199
First received: October 12, 2005
Last updated: April 22, 2015
Last verified: April 2015
  Purpose

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 Intervention Phase
Pancreatic Cancer Dietary Supplement: calcitriol Drug: docetaxel Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Time to progression

Secondary Outcome Measures:
  • Median and one-year survival
  • Overall response
  • Toxicity
  • Change in pancreatic cancer-induced pain

Enrollment: 25
Study Start Date: June 2002
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238199

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

Responsible Party: Charles Blanke, Oregon Health and Science University Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00238199     History of Changes
Other Study ID Numbers: CDR0000445077
OHSU-GIM-02007-L
OHSU-1104
Study First Received: October 12, 2005
Last Updated: April 22, 2015

Keywords provided by OHSU Knight Cancer Institute:
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Docetaxel
Calcitriol
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 18, 2017