PURPOSE: To determine the safety and efficacy of weekly high-dose oral calcitriol (Rocaltrol, Roche Pharmaceuticals, Basel, Switzerland) and docetaxel (Taxotere, Aventis Pharmaceuticals, Bridgewater, NJ) in patients with metastatic androgen-independent prostate cancer (AIPC). PATIENTS AND METHODS: Thirty-seven patients were treated with oral calcitriol (0.5 micro g/kg) on day 1 followed by docetaxel (36 mg/m(2)) on day 2, repeated weekly for 6 weeks of an 8-week cycle. Patients maintained a reduced calcium diet and increased oral hydration. Prostate-specific antigen (PSA) response was the primary end point, which was defined as a 50% reduction in PSA level confirmed 4 weeks later. RESULTS: Thirty of 37 patients (81%; 95% confidence interval [CI], 68% to 94%) achieved a PSA response. Twenty-two patients (59%; 95% CI, 43% to 75%) had a confirmed > 75% reduction in PSA. Eight of the 15 patients with measurable disease (53%; 95% CI, 27% to 79%) had a confirmed partial response. Median time to progression was 11.4 months (95% CI, 8.7 to 14 months), and median survival was 19.5 months (95% CI, 15.3 months to incalculable). Overall survival at 1 year was 89% (95% CI, 74% to 95%). Treatment-related toxicity was generally similar to that expected with single-agent docetaxel. Pharmacokinetics of either calcitriol or docetaxel were not affected by the presence of its companion drug in an exploratory substudy. CONCLUSION: The combination of weekly oral high-dose calcitriol and weekly docetaxel is a well-tolerated regimen for AIPC. PSA and measurable disease response rates as well as time to progression and survival are promising when compared with contemporary phase II studies of single-agent docetaxel in AIPC. Further study of this regimen is warranted.
PURPOSE: To determine the safety and efficacy of weekly high-dose oral calcitriol (Rocaltrol, Roche Pharmaceuticals, Basel, Switzerland) and docetaxel (Taxotere, Aventis Pharmaceuticals, Bridgewater, NJ) in patients with metastatic androgen-independent prostate cancer (AIPC). PATIENTS AND METHODS: Thirty-seven patients were treated with oral calcitriol (0.5 micro g/kg) on day 1 followed by docetaxel (36 mg/m(2)) on day 2, repeated weekly for 6 weeks of an 8-week cycle. Patients maintained a reduced calcium diet and increased oral hydration. Prostate-specific antigen (PSA) response was the primary end point, which was defined as a 50% reduction in PSA level confirmed 4 weeks later. RESULTS: Thirty of 37 patients (81%; 95% confidence interval [CI], 68% to 94%) achieved a PSA response. Twenty-two patients (59%; 95% CI, 43% to 75%) had a confirmed > 75% reduction in PSA. Eight of the 15 patients with measurable disease (53%; 95% CI, 27% to 79%) had a confirmed partial response. Median time to progression was 11.4 months (95% CI, 8.7 to 14 months), and median survival was 19.5 months (95% CI, 15.3 months to incalculable). Overall survival at 1 year was 89% (95% CI, 74% to 95%). Treatment-related toxicity was generally similar to that expected with single-agent docetaxel. Pharmacokinetics of either calcitriol or docetaxel were not affected by the presence of its companion drug in an exploratory substudy. CONCLUSION: The combination of weekly oral high-dose calcitriol and weekly docetaxel is a well-tolerated regimen for AIPC. PSA and measurable disease response rates as well as time to progression and survival are promising when compared with contemporary phase II studies of single-agent docetaxel in AIPC. Further study of this regimen is warranted.
Authors: Renee C Prins; Brooks L Rademacher; Solange Mongoue-Tchokote; Joshi J Alumkal; Julie N Graff; Kristine M Eilers; Tomasz M Beer Journal: Urol Oncol Date: 2010-03-06 Impact factor: 3.498
Authors: Naing Lin Shan; Joseph Wahler; Hong Jin Lee; Min Ji Bak; Soumyasri Das Gupta; Hubert Maehr; Nanjoo Suh Journal: J Steroid Biochem Mol Biol Date: 2016-12-05 Impact factor: 4.292
Authors: L J Peppone; S Hebl; J Q Purnell; M E Reid; R N Rosier; K M Mustian; O G Palesh; A J Huston; M N Ling; G R Morrow Journal: Osteoporos Int Date: 2009-12-04 Impact factor: 4.507
Authors: Sara Karami; Paul Brennan; Philip S Rosenberg; Marie Navratilova; Dana Mates; David Zaridze; Vladimir Janout; Helena Kollarova; Vladimir Bencko; Vsevolod Matveev; Neonila Szeszenia-Dabrowska; Ivana Holcatova; Meredith Yeager; Stephen Chanock; Idan Menashe; Nathaniel Rothman; Wong-Ho Chow; Paolo Boffetta; Lee E Moore Journal: PLoS One Date: 2009-09-15 Impact factor: 3.240
Authors: Adebusola A Alagbala; Michael T Moser; Candace S Johnson; Donald L Trump; Barbara A Foster Journal: J Steroid Biochem Mol Biol Date: 2007-02-05 Impact factor: 4.292