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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00238199
First received: October 12, 2005
Last updated: August 6, 2009
Last verified: August 2009
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Oregon Health and Science University:

Primary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median and one-year survival [ Designated as safety issue: No ]
  • Overall response [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Change in pancreatic cancer-induced pain [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of pancreatic cancer

    • Locally advanced or metastatic disease

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • 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
  • ALT and 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
Oregon Health and Science University
Sanofi
Investigators
Principal Investigator: Charles D. Blanke, MD, FACP OHSU Knight Cancer Institute
  More Information

Additional Information:
No publications provided

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: August 6, 2009
Health Authority: United States: Federal Government

Keywords provided by Oregon Health and Science University:
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
Calcitriol
Docetaxel
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 23, 2014