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

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: Sanofi
• Treatments: Calcitriol; Docetaxel

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

• 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