A phase II trial of the vitamin D analogue Seocalcitol (EB1089) in patients with inoperable pancreatic cancer
2002

Vitamin D Analogue Seocalcitol in Pancreatic Cancer

Sample size: 36 publication Evidence: low

Author Information

Author(s): Evans T R J, Colston K W, Lofts F J, Cunningham D, Anthoney D A, Gogas H, de Bono J S, Hamberg K J, Skov T, Mansi J L

Primary Institution: Beatson Oncology Centre, Glasgow

Hypothesis

Does the vitamin D analogue Seocalcitol have anti-tumour activity in patients with inoperable pancreatic cancer?

Conclusion

Seocalcitol is well tolerated in pancreatic cancer but has no objective anti-tumour activity in advanced disease.

Supporting Evidence

  • No objective responses were observed in the study.
  • Five of 14 patients had stable disease for a median of 168 days.
  • The most frequent toxicity was dose-dependent hypercalcaemia.

Takeaway

Doctors tested a vitamin D-like medicine on patients with pancreatic cancer, but it didn't help shrink the tumors.

Methodology

A multi-centre, open, non-controlled trial with dose escalation of seocalcitol until hypercalcaemia occurred.

Potential Biases

Potential bias due to the non-randomized design and the small sample size of evaluable patients.

Limitations

The study was non-randomized and lacked a comparator group, making it difficult to determine the efficacy of seocalcitol.

Participant Demographics

Mean age 60.7 years, 29 males and 14 females, primarily Caucasian.

Statistical Information

P-Value

p<0.001

Statistical Significance

p<0.001

Digital Object Identifier (DOI)

10.1038/sj/bjc/6600162

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