Official Title: “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 Type: Interventional

Study Design: Treatment, Open Label

Study Primary Completion Date: August 2006

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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: calcitriol
• Drug: docetaxel

Primary Measures

• Time to progression
  • Safety Issue?: No

Secondary Measures

• Median and one-year survival
  • Safety Issue?: No
• Overall response
  • Safety Issue?: No
• Toxicity
  • Safety Issue?: Yes
• Change in pancreatic cancer-induced pain
  • Safety Issue?: No

DISEASE CHARACTERISTICS:

• Diagnosis of pancreatic cancer
• Locally advanced or metastatic disease

PATIENT CHARACTERISTICS:

• Age
• Over 18
• Performance status
• ECOG 0-2
• Life expectancy
• Not specified
• Hematopoietic
• 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
• ALT and 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Oregon Health and Science University

Overall Clinical Trial Officials and Contacts

Charles D. Blanke, MD, FACP Principal Investigator Oregon Health and Science University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00238199

Study ID Number: CDR0000445077

ClinicalTrials.gov Identifier: NCT00238199

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database