A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer

Joseph S. Chan, Tomasz (Tom) Beer, David I. Quinn, Jacek K. Pinski, Mark Garzotto, Mitchell Sokoloff, Daniel R. Dehaze, Christopher Ryan

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

OBJECTIVE: To evaluate the preliminary efficacy, safety, and impact on quality of life (QoL) of high-dose calcitriol (DN-101) combined with mitoxantrone and glucocorticoids in androgen-independent prostate cancer (AIPC). PATIENTS AND METHODS: Nineteen patients with metastatic AIPC and no previous chemotherapy received DN-101 180 μg orally on day 1 and mitoxantrone 12 mg/m2 intravenously on day 2 every 21 days with continuous daily prednisone 10 mg orally for a maximum of 12 cycles. A confirmed decline in prostate-specific antigen (PSA) levels by half was the primary endpoint. QoL was evaluated using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire, and pain and analgesic use were evaluated. RESULTS: Five of 19 patients (26%; 95% confidence interval, CI, 9-51) achieved a ≥50% decline in PSA level. The median (95% CI) time to PSA progression was 16 (6-26) weeks. The overall median (95% CI) survival was 16 (6-26) months; 47 (21-73)% of patients achieved an analgesic response. Toxicity was similar to that expected with mitoxantrone and prednisone alone. The QoL analysis suggested a decrease in physical functioning and increase in fatigue, insomnia, and diarrhoea. CONCLUSIONS: DN-101 given every 3 weeks does not add significant activity to mitoxantrone and prednisone in AIPC, as measured by the PSA decline. The high rate of analgesic response is encouraging. The addition of DN-101 does not appear to increase the toxicity of mitoxantrone.

Original languageEnglish (US)
Pages (from-to)1601-1606
Number of pages6
JournalBJU International
Volume102
Issue number11
DOIs
StatePublished - Dec 2008

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Mitoxantrone
Calcitriol
Prednisone
Androgens
Prostatic Neoplasms
Prostate-Specific Antigen
Analgesics
Quality of Life
Sleep Initiation and Maintenance Disorders
Glucocorticoids
Fatigue
Diarrhea
Organizations
Confidence Intervals
Safety
Drug Therapy
Pain
Survival
Research
Neoplasms

Keywords

  • Calcitriol
  • DN-101
  • Mitoxantrone
  • Prostate cancer

ASJC Scopus subject areas

  • Urology

Cite this

A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer. / Chan, Joseph S.; Beer, Tomasz (Tom); Quinn, David I.; Pinski, Jacek K.; Garzotto, Mark; Sokoloff, Mitchell; Dehaze, Daniel R.; Ryan, Christopher.

In: BJU International, Vol. 102, No. 11, 12.2008, p. 1601-1606.

Research output: Contribution to journalArticle

Chan, Joseph S. ; Beer, Tomasz (Tom) ; Quinn, David I. ; Pinski, Jacek K. ; Garzotto, Mark ; Sokoloff, Mitchell ; Dehaze, Daniel R. ; Ryan, Christopher. / A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer. In: BJU International. 2008 ; Vol. 102, No. 11. pp. 1601-1606.
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T1 - A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer

AU - Chan, Joseph S.

AU - Beer, Tomasz (Tom)

AU - Quinn, David I.

AU - Pinski, Jacek K.

AU - Garzotto, Mark

AU - Sokoloff, Mitchell

AU - Dehaze, Daniel R.

AU - Ryan, Christopher

PY - 2008/12

Y1 - 2008/12

N2 - OBJECTIVE: To evaluate the preliminary efficacy, safety, and impact on quality of life (QoL) of high-dose calcitriol (DN-101) combined with mitoxantrone and glucocorticoids in androgen-independent prostate cancer (AIPC). PATIENTS AND METHODS: Nineteen patients with metastatic AIPC and no previous chemotherapy received DN-101 180 μg orally on day 1 and mitoxantrone 12 mg/m2 intravenously on day 2 every 21 days with continuous daily prednisone 10 mg orally for a maximum of 12 cycles. A confirmed decline in prostate-specific antigen (PSA) levels by half was the primary endpoint. QoL was evaluated using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire, and pain and analgesic use were evaluated. RESULTS: Five of 19 patients (26%; 95% confidence interval, CI, 9-51) achieved a ≥50% decline in PSA level. The median (95% CI) time to PSA progression was 16 (6-26) weeks. The overall median (95% CI) survival was 16 (6-26) months; 47 (21-73)% of patients achieved an analgesic response. Toxicity was similar to that expected with mitoxantrone and prednisone alone. The QoL analysis suggested a decrease in physical functioning and increase in fatigue, insomnia, and diarrhoea. CONCLUSIONS: DN-101 given every 3 weeks does not add significant activity to mitoxantrone and prednisone in AIPC, as measured by the PSA decline. The high rate of analgesic response is encouraging. The addition of DN-101 does not appear to increase the toxicity of mitoxantrone.

AB - OBJECTIVE: To evaluate the preliminary efficacy, safety, and impact on quality of life (QoL) of high-dose calcitriol (DN-101) combined with mitoxantrone and glucocorticoids in androgen-independent prostate cancer (AIPC). PATIENTS AND METHODS: Nineteen patients with metastatic AIPC and no previous chemotherapy received DN-101 180 μg orally on day 1 and mitoxantrone 12 mg/m2 intravenously on day 2 every 21 days with continuous daily prednisone 10 mg orally for a maximum of 12 cycles. A confirmed decline in prostate-specific antigen (PSA) levels by half was the primary endpoint. QoL was evaluated using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire, and pain and analgesic use were evaluated. RESULTS: Five of 19 patients (26%; 95% confidence interval, CI, 9-51) achieved a ≥50% decline in PSA level. The median (95% CI) time to PSA progression was 16 (6-26) weeks. The overall median (95% CI) survival was 16 (6-26) months; 47 (21-73)% of patients achieved an analgesic response. Toxicity was similar to that expected with mitoxantrone and prednisone alone. The QoL analysis suggested a decrease in physical functioning and increase in fatigue, insomnia, and diarrhoea. CONCLUSIONS: DN-101 given every 3 weeks does not add significant activity to mitoxantrone and prednisone in AIPC, as measured by the PSA decline. The high rate of analgesic response is encouraging. The addition of DN-101 does not appear to increase the toxicity of mitoxantrone.

KW - Calcitriol

KW - DN-101

KW - Mitoxantrone

KW - Prostate cancer

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