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Sponsors and Collaborators: |
Oregon Health and Science University Sanofi-Aventis |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00238199 |
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 |
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Pancreatic Cancer |
Dietary Supplement: calcitriol Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study of Calcitriol-Enhanced Docetaxel in Patients With Previously Untreated Metastatic or Locally Advanced Pancreatic Cancer |
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) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of pancreatic cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior adjuvant docetaxel
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Oregon | |
Oregon Health & Science University Cancer Institute | |
Portland, Oregon, United States, 97239-3098 |
Principal Investigator: | Charles D. Blanke, MD, FACP | OHSU Knight Cancer Institute |
Responsible Party: | Oregon Health and Science University Knight Cancer Institute ( Charles Blanke ) |
Study ID Numbers: | CDR0000445077, OHSU-GIM-02007-L, OHSU-1104 |
Study First Received: | October 12, 2005 |
Last Updated: | August 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00238199 History of Changes |
Health Authority: | United States: Federal Government |
stage III pancreatic cancer stage IV pancreatic cancer |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Bone Density Conservation Agents Trace Elements Cardiovascular Agents Calcitriol Docetaxel Calcium, Dietary |
Digestive System Diseases Vitamins Vasoconstrictor Agents Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Micronutrients Endocrine Gland Neoplasms |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Growth Substances Calcium Channel Agonists Physiological Effects of Drugs Endocrine System Diseases Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions Calcitriol |
Membrane Transport Modulators Docetaxel Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Vitamins Vasoconstrictor Agents Pancreatic Diseases Micronutrients Endocrine Gland Neoplasms |