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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of Calcitriol-Enhanced Docetaxel in Patients With Previously Untreated Metastatic or Locally Advanced Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Dietary Supplement: calcitriol
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: calcitriol|nan|
|Drug: docetaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median and one-year survival |  |  | 
| Overall response |  |  | 
| Toxicity |  |  | 
| Change in pancreatic cancer-induced pain |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III pancreatic cancer, stage IV pancreatic cancer