- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00238199
Calcitriol and Docetaxel in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
Phase II Study of Calcitriol-Enhanced Docetaxel in Patients With Previously Untreated Metastatic or Locally Advanced Pancreatic Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Oregon
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Portland, Oregon, United States, 97239-3098
- Oregon Health & Science University Cancer Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Time to progression
|
Secondary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Overall response
|
Median and one-year survival
|
Change in pancreatic cancer-induced pain
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Charles D. Blanke, MD, FACP, OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Micronutrients
- Membrane Transport Modulators
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vasoconstrictor Agents
- Calcium Channel Agonists
- Docetaxel
- Calcitriol
Other Study ID Numbers
- CDR0000445077
- OHSU-GIM-02007-L
- OHSU-1104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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