A phase i study of combined docetaxel and repeated high activity 186Re-HEDP in castration-resistant prostate cancer (CRPC) metastatic to bone (the TAXIUM trial)

European Journal of Nuclear Medicine and Molecular Imaging

Volumn 38, Issue 11, 2011, Pages 1990-1998

  Van Dodewaard De Jong, Joyce M ^a   De Klerk, John M H ^a   Bloemendal, Haiko J ^a   Van Bezooijen, Bart P J ^a   De Haas, Marie J ^a   Wilson, Richard H ^b   O'Sullivan, Joe M ^b  

^a MEANDER MEDICAL CENTER   (Netherlands)

^b QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

Author keywords

186Re HEDP; Chemoradiation; Docetaxel; Prostate carcinoma; Radionuclide

Indexed keywords

DOCETAXEL; ETIDRONIC ACID RE 186;

ACUTE KIDNEY FAILURE; ADULT; AGED; ALOPECIA; ANEMIA; ARTHRALGIA; ARTICLE; BONE METASTASIS; BONE PAIN; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CASTRATION RESISTANT PROSTATE CANCER; CLINICAL ARTICLE; CONSTIPATION; DIARRHEA; DRUG ACTIVITY; DRUG DOSE ESCALATION; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; HUMAN; HYPERGLYCEMIA; HYPOKALEMIA; LEG CRAMP; LEG EDEMA; LEUKOPENIA; MOUTH PAIN; MOUTH ULCER; MUCOSA INFLAMMATION; MYALGIA; NAIL DISEASE; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; POLLAKISURIA; SENSORY NEUROPATHY; SIDE EFFECT; TASTE DISORDER; THROMBOCYTOPENIA; TOXICITY TESTING; XEROSTOMIA;

AGED; BONE NEOPLASMS; CHEMORADIOTHERAPY; ETIDRONIC ACID; HUMANS; MALE; MIDDLE AGED; ORCHIECTOMY; ORGANOMETALLIC COMPOUNDS; PROSTATIC NEOPLASMS; RADIOTHERAPY DOSAGE; TAXOIDS; TREATMENT OUTCOME;

EID: 80255141929     PISSN: 16197070     EISSN: 16197089     Source Type: Journal    
DOI: 10.1007/s00259-011-1883-0     Document Type: Article

References (29)

1. NJ Vogelzang ED Crawford A Zietman 1998 Current clinical trial design issues in hormone-refractory prostate carcinoma. Consensus Panel Cancer 82 2093 2101 9610688 10.1002/(SICI)1097-0142(19980601)82:11<2093::AID-CNCR3>3.0. CO;2-X 1:STN:280:DyaK1c3nt1aiuw%3D%3D (Pubitemid 28240815)
2. NW Clarke 2006 Management of the spectrum of hormone refractory prostate cancer Eur Urol 50 428 439 16797118 10.1016/j.eururo.2006.05.017 1:CAS:528:DC%2BD28XhtVSrs77K (Pubitemid 44189073)
3. IF Tannock R de Wit WR Berry J Horti A Pluzanska KN Chi, et al. 2004 Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer N Engl J Med 351 1502 1512 15470213 10.1056/NEJMoa040720 1:CAS:528:DC%2BD2cXot1Kmu7s%3D (Pubitemid 39315317)
4. DP Petrylak CM Tangen MH Hussain PN Lara Jr JA Jones ME Taplin, et al. 2004 Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer N Engl J Med 351 1513 1520 15470214 10.1056/NEJMoa041318 1:CAS:528:DC%2BD2cXot1Kmu7c%3D (Pubitemid 39315318)
5. M Roqué MJ Martinez P Alonso E Català JL Garcia M Ferrandiz 2003 Radioisotopes for metastatic bone pain Cochrane Database Syst Rev 4 CD003347 14583970
6. SH Han JM de Klerk S Tan AD van het Schip BH Derksen A van Dijk, et al. 2002 The PLACORHEN study: a double-blind, placebo-controlled, randomized radionuclide study with (186)Re-etidronate in hormone-resistant prostate cancer patients with painful bone metastases. Placebo Controlled Rhenium study J Nucl Med 43 1150 1156 12215552 1:CAS:528:DC%2BD38Xns1elsr0%3D (Pubitemid 34988760)
7. H Palmedo A Manka-Waluch P Albers IG Schmidt-Wolf M Reinhardt S Ezziddin, et al. 2003 Repeated bone-targeted therapy for hormone-refractory prostate carcinoma: randomized phase II trial with the new, high-energy radiopharmaceutical rhenium-188 hydroxyethylidenediphosphonate J Clin Oncol 21 2869 2875 12885803 10.1200/JCO.2003.12.060 1:CAS:528:DC%2BD2cXpsVKjtr4%3D (Pubitemid 46621835)
8. JM O'Sullivan AR Norman VR McCready G Flux FM Buffa B Johnson, et al. 2006 A phase 2 study of high-activity 186Re-HEDP with autologous peripheral blood stem cell transplant in progressive hormone-refractory prostate cancer metastatic to bone Eur J Nucl Med Mol Imaging 33 1055 1061 16572306 10.1007/s00259-005-0010-5 (Pubitemid 44215671)
9. SM Tu RE Millikan B Mengistu ES Delpassand RJ Amato LC Pagliaro, et al. 2001 Bone-targeted therapy for advanced androgen-independent carcinoma of the prostate: a randomised phase II trial Lancet 357 336 341 11210994 10.1016/S0140-6736(00)03639-4 1:STN:280:DC%2BD3M7is1yjtQ%3D%3D (Pubitemid 32128538)
10. MJ Morris N Pandit-Taskar J Carrasquillo CR Divgi S Slovin WK Kelly, et al. 2009 Phase I study of samarium-153 lexidronam with docetaxel in castration-resistant metastatic prostate cancer J Clin Oncol 27 2436 2442 19364960 10.1200/JCO.2008.20.4164 1:CAS:528:DC%2BD1MXmvVOhsL4%3D
11. K Fizazi P Beuzeboc J Lumbroso V Haddad C Massard M Gross-Goupil, et al. 2009 Phase II trial of consolidation docetaxel and samarium-153 in patients with bone metastases from castration-resistant prostate cancer J Clin Oncol 27 2429 2435 19364971 10.1200/JCO.2008.18.9811 1:CAS:528:DC%2BD1MXmvVOhs7Y%3D
12. MG Lam TB Bosma PP van Rijk BA Zonnenberg 2009 (188)Re-HEDP combined with capecitabine in hormone-refractory prostate cancer patients with bone metastases: a phase I safety and toxicity study Eur J Nucl Med Mol Imaging 36 1425 1433 19319526 10.1007/s00259-009-1119-8 1:CAS:528:DC%2BD1MXps1Ckt78%3D
13. SM Tu P Mathew FC Wong D Jones MM Johnson CJ Logothetis 2009 Phase I study of concurrent weekly docetaxel and repeated samarium-153 lexidronam in patients with castration-resistant metastatic prostate cancer J Clin Oncol 27 3319 3324 19414670 10.1200/JCO.2008.20.5393 1:CAS:528:DC%2BD1MXpvFejt7o%3D
14. MG Lam JM de Klerk PP van Rijk BA Zonnenberg 2007 Bone seeking radiopharmaceuticals for palliation in cancer patients with osseous metastases Anticancer Agents Med Chem 7 381 397 17630915 10.2174/187152007781058596 1:CAS:528:DC%2BD2sXmsV2htrc%3D (Pubitemid 47099046)
15. MG Lam A Hoekstra JM de Klerk PP van Rijk BA Zonnenberg 2009 Radiation safety considerations for the bone seeking radiopharmaceuticals 89SrCl2, 186Re-HEDP and 153Sm-EDTMP Nuklearmedizin 48 37 43 19212610 1:CAS:528: DC%2BD1MXksVOqtr0%3D
16. SH Han JM de Klerk BA Zonnenberg S Tan PP van Rijk 2001 186Re-etidronate. Efficacy of palliative radionuclide therapy for painful bone metastases Q J Nucl Med 45 84 90 11456380 1:STN:280:DC%2BD3MvgsFCmsw%3D%3D (Pubitemid 32586345)
17. JM de Klerk BA Zonnenberg AD van het Schip A van Dijk AW Huiskes PP van Rijk 1999 Can bone marrow scintigraphy predict platelet toxicity after treatment with 186Re-HEDP? Nucl Med Commun 20 833 836 10533189 10.1097/00006231- 199909000-00009 (Pubitemid 29508706)
18. SH Han BA Zonnenberg JM de Klerk JM Quirijnen AD van het Schip A van Dijk, et al. 1999 186Re-etidronate in breast cancer patients with metastatic bone pain J Nucl Med 40 639 642 10210223 1:STN:280:DyaK1M3isV2huw%3D%3D (Pubitemid 29171806)
19. JM De Klerk BA Zonnenberg GH Blijham AD van Het Schip A Hoekstra SH Han, et al. 1997 Treatment of metastatic bone pain using the bone seeking radiopharmaceutical Re-186-HEDP Anticancer Res 17 1773 1777 9179233 (Pubitemid 27263160)
20. JM Quirijnen SH Han BA Zonnenberg JM de Klerk AD van het Schip A van Dijk, et al. 1996 Efficacy of rhenium-186-etidronate in prostate cancer patients with metastatic bone pain J Nucl Med 37 1511 1515 8790203 1:CAS:528: DyaK28XlvF2mtr4%3D (Pubitemid 26321632)
21. JM de Klerk AD van het Schip BA Zonnenberg A van Dijk JM Quirijnen GH Blijham, et al. 1996 Phase 1 study of rhenium-186-HEDP in patients with bone metastases originating from breast cancer J Nucl Med 37 244 249 8667053 (Pubitemid 26150896)
22. JM de Klerk EB van Dieren AD van het Schip A Hoekstra BA Zonnenberg A van Dijk, et al. 1996 Bone marrow absorbed dose of rhenium-186-HEDP and the relationship with decreased platelet counts J Nucl Med 37 38 41 8543998 (Pubitemid 26123422)
23. JM de Klerk BA Zonnenberg AD van het Schip A van Dijk SH Han JM Quirijnen, et al. 1994 Dose escalation study of rhenium-186-hydroxyethylidene diphosphonate in patients with metastatic prostate cancer Eur J Nucl Med 21 1114 1120 7530199 10.1007/BF00181067 (Pubitemid 24304438)
24. JM de Klerk AD van het Schip BA Zonnenberg A van Dijk MP Stokkel SH Han, et al. 1994 Evaluation of thrombocytopenia in patients treated with rhenium-186-HEDP: guidelines for individual dosage recommendations J Nucl Med 35 1423 1428 8071686 (Pubitemid 24280446)
25. JM de Klerk A van Dijk AD van het Schip BA Zonnenberg PP van Rijk 1992 Pharmacokinetics of rhenium-186 after administration of rhenium-186-HEDP to patients with bone metastases J Nucl Med 33 646 651 1373767
26. FM Buffa GD Flux MJ Guy JM O'Sullivan VR McCready SJ Chittenden, et al. 2003 A model-based method for the prediction of whole-body absorbed dose and bone marrow toxicity for 186Re-HEDP treatment of skeletal metastases from prostate cancer Eur J Nucl Med Mol Imaging 30 1114 1124 12761596 10.1007/s00259-003-1197-y 1:CAS:528:DC%2BD3sXlslGrt7Y%3D (Pubitemid 36988223)
27. JM O'Sullivan VR McCready G Flux AR Norman FM Buffa S Chittenden, et al. 2002 High activity rhenium-186-HEDP with autologous peripheral blood stem cell rescue: a phase I study in progressive hormone refractory prostate cancer metastatic to bone Br J Cancer 86 1715 1720 12087455 10.1038/sj.bjc.6600348 (Pubitemid 34712913)
28. K Liepe J Kotzerke 2007 A comparative study of 188Re-HEDP, 186Re-HEDP, 153Sm-EDTMP and 89Sr in treatment of painful skeletal metastases Nucl Med Commun 28 623 630 17625384 10.1097/MNM.0b013e32825a6adc 1:CAS:528:DC%2BD2sXnsFOjt7k%3D (Pubitemid 47067049)
29. H Palmedo S Guhlke H Bender J Sartor G Schoeneich J Risse, et al. 2000 Dose escalation study with rhenium-188 hydroxyethylidene diphosphonate in prostate cancer patients with osseous metastases Eur J Nucl Med 27 123 130 10755716 10.1007/s002590050017 1:CAS:528:DC%2BD3cXovVWlsw%3D%3D (Pubitemid 30102016)