Phase II study of calcitriol-enhanced docetaxel in patients with previously untreated metastatic or locally advanced pancreatic

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Invest New Drugs. 2009 Aug;27(4):374-8. Epub 2008 Oct 9.

Phase II study of calcitriol-enhanced docetaxel in patients with previously
untreated metastatic or locally advanced pancreatic cancer.


Blanke CD, Beer TM, Todd K, Mori M, Stone M, Lopez C.

British Columbia Cancer Agency and University of British Columbia, BC, Canada.

PURPOSE: To determine the safety and efficacy of weekly high-dose oral
calcitriol and docetaxel, given to patients with non-resectable,
incurable pancreatic cancer.
PATIENTS AND METHODS: Twenty-five patients
were enrolled onto this phase II study. Patients were treated with oral
calcitriol 0.5 microg/kg on day 1, followed by docetaxel 36 mg/m(2) IV
on day 2, administered weekly for three consecutive weeks, followed by
1 week without treatment. Patients followed a low-calcium diet and
increased their hydration. The primary end-point of the trial was
time-to-progression.
RESULTS: Three of 25 patients attained a partial
response (12%, 95% CI 3 to 31) and seven (28%) achieved stable disease.
Median time-to-progression was 15 weeks, and median overall survival
was 24 weeks. Toxicities observed (hyperglycemia, fatigue) were mostly
attributable to the docetaxel or its pre-treatment.
CONCLUSIONS: This
regimen of high-dose calcitriol with docetaxel may have activity in
incurable pancreatic cancer, with a modest increase in TTP when
compared to historical findings using single-agent docetaxel. However,
results do not appear superior to those seen with gemcitabine, with or
without erlotinib.