Phase II study of calcitriol-enhanced docetaxel in patients with previously untreated metastatic or locally advanced pancreatic cancer.
OBJECTIVE
To determine the safety and efficacy of weekly high-dose oral calcitriol and docetaxel, given to patients with non-resectable, incurable pancreatic cancer.


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.
Blanke
C D
CD
British Columbia Cancer Agency and University of British Columbia, BC, Canada. cblanke@bccancer.bc.ca
Beer
T M
TM
Todd
K
K
Mori
M
M
Stone
M
M
Lopez
C
C
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D002117:Calcitriol / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D002120:Calcium Channel Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D002136:Calcium, Dietary; D018450:Disease Progression; D000077143:Docetaxel; D004359:Drug Therapy, Combination; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D002120:Calcium Channel Agonists; D002136:Calcium, Dietary; D043823:Taxoids; D000077143:Docetaxel; D002117:Calcitriol