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

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.

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