Calcitriol and Docetaxel in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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.
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Determine the overall response in patients treated with this regimen.
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Determine the toxic effects of this regimen in these patients.
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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 Design
Outcome Measures
Primary Outcome Measures
- Time to progression []
Secondary Outcome Measures
- Median and one-year survival []
- Overall response []
- Toxicity []
- Change in pancreatic cancer-induced pain []
Eligibility Criteria
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
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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
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Calcium < 10.5 mg/dL
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Phosphate < 4.7 mg/dL
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No kidney stones within the past 5 years
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No history of hypercalcemia
Cardiovascular
-
No myocardial infarction within the past 3 months
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No uncontrolled heart failure with a known ejection fraction < 30%
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No other significant heart disease
Other
-
Not pregnant or nursing
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Fertile patients must use effective contraception
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No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
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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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000445077
- OHSU-GIM-02007-L
- OHSU-1104