A phase i trial of samarium-153-lexidronam complex for treatment of clinically nonmetastatic high-risk prostate cancer: First report of a completed study

International Journal of Radiation Oncology Biology Physics

Volumn 79, Issue 3, 2011, Pages 732-737

  Valicenti, Richard K ^a   Trabulsi, Edouard ^b   Intenzo, Charles ^b   Lavarino, Jorosali ^a   Xu, Yihuan ^b   Chervoneva, Inna ^b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b THOMAS JEFFERSON UNIVERSITY   (United States)

Author keywords

Hormonal therapy; Prostate cancer; Radiation therapy; Samarium 153

Indexed keywords

GLEASON SCORES; HEMATOLOGIC TOXICITY; HORMONAL THERAPY; MAXIMUM TOLERATED DOSE; NATIONAL CANCER INSTITUTE; PHASE I; PHASE II; POSTOPERATIVE THERAPY; PROSTATE CANCERS; PROSTATE SPECIFIC ANTIGEN; RADIATION THERAPY; RADIATION THERAPY ONCOLOGY GROUPS; SIDE EFFECT; UP TIME;

ANTIGENS; DISEASES; SAMARIUM; TOXICITY;

RADIOTHERAPY;

BICALUTAMIDE; FLUTAMIDE; GOSERELIN; HEMOGLOBIN; LEUPRORELIN; LEXIDRONAM SAMARIUM SM 153; PROSTATE SPECIFIC ANTIGEN;

ADULT; AGED; ANDROGEN DEPRIVATION THERAPY; ARTICLE; BLOOD TOXICITY; CANCER HORMONE THERAPY; CANCER RADIOTHERAPY; CANCER STAGING; DERMATITIS; DOSE RESPONSE; DRUG DOSE ESCALATION; EXTERNAL BEAM RADIOTHERAPY; FEASIBILITY STUDY; FOLLOW UP; GLEASON SCORE; HIGH RISK PATIENT; HUMAN; LEUKOCYTE; MALE; MAXIMUM TOLERATED DOSE; PATIENT SAFETY; PHASE 1 CLINICAL TRIAL; POSTOPERATIVE CARE; PRIORITY JOURNAL; PROSTATE CANCER; PROSTATECTOMY; RADIATION DOSE; SIDE EFFECT; THROMBOCYTE; TREATMENT PLANNING;

AGED; AGED, 80 AND OVER; COMBINED MODALITY THERAPY; FEASIBILITY STUDIES; HUMANS; LEUKOPENIA; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; ORGANOMETALLIC COMPOUNDS; ORGANOPHOSPHORUS COMPOUNDS; PROSPECTIVE STUDIES; PROSTATE-SPECIFIC ANTIGEN; PROSTATECTOMY; PROSTATIC NEOPLASMS; RADIOTHERAPY DOSAGE; THROMBOCYTOPENIA;

EID: 79551468928     PISSN: 03603016     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2009.11.011     Document Type: Article

References (19)

1. A. Jemal, R. Siegel, and E. Ward Cancer statistics CA Cancer J Clin 59 2009 225 249
2. M.V. Pilepich, K. Winter, and M.J. John Phase III Radiation Therapy Oncology Group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate Int J. Radiat Oncol Biol Phys 50 2001 1243 1252
3. M.S. Soloway, S.W. Hardeman, and D. Hickey Stratification of patients with metastatic prostate cancer base on extent of disease on initial bone scan Cancer 61 1998 195 202
4. A. Porter, A.J.B. McEwan, and J.E. Powe Results of a randomized Phase-III trial to evaluate the efficacy of strontium-89 adjuvant to local field external beam irradiation in the management of endocrine resistant metastatic prostate cancer Int J Radiat Oncol Biol Phys 25 1993 805 813
5. A.N. Serafini Samarium sm-153 lexidronam for the palliation of bone pain associated with metastases Cancer 88 2000 2934 2939
6. E. Silberstein Systemic radiopharmaceutical therapy of painful osteoblastic metastases Semin Radiat Oncol 10 2000 240 249
7. C. Collins, J.F. Eary, and G. Donaldson Samerium-153-EDTMP in bone metastases of hormone refractory prostate carcinoma: A Phase II trial J Nucl Med 34 1993 1839 1844
8. T.F. Sandeman, R.S. Budd, and J.J. Martin Samarium 153-labeled EDTMP for bone metastases from cancer of the prostate Clin Oncol 4 1992 160 164
9. 153 Sm-ethylenediaminetetramethylenophosphate (EDTMP) in the treatment of patients with painful bone metastases Eur J Cancer 33 1997 1583 1591
10. A.N. Serafini, S.J. Houston, and L. Resche Palliation of pain associated with metastatic bone cancer using Samarium 153 lexidronam: A double-blind placebo-controlled clinical rail J Clin Oncol 16 1998 1574 1581
11. O. Sartor, R.H. Reid, and P.J. Hoskin Quadramet 424Sm10/11 study group samarium 153-lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer Urology 63 2004 940 945
12. S. Tu, R. Millikan, and B. Mengistu Bone-targeted therapy for advanced androgen independent carcinoma of the prostate: A randomized Phase II trial Lancet 357 2001 336 341
13. S.M. Tu, J. Kim, and L.C. Pagliaro Therapy tolerance in selected patients with androgen-independent prostate cancer following strontium-89 combined with chemotherapy J Clin Oncol 23 2005 7904 7910
14. J.R. Berenson, O. Yellin, and R. Patet A Phase I study of samarium lexidronam/bortezomib combination therapy for the treatment of relapsed or refractory multiple myeloma Clin Cancer Res 15 2009 1069 1075
15. E.N. Atkinson, and B.W. Brown Confidence limits for probability of response in multistage Phase II clinical trials Biometrics 41 1985 741 744
16. W.J. Conover Practical nonparametric statistics 2nd ed. 1980 Wiley New York
17. G.E. Hanks, T.F. Pajak, and A. Porter Phase III trial of long-term HT after neoadjuvant HT and radiotherapy in locally advanced carcinoma of the prostate. The Radiation Therapy Oncology Group Protcol 92-02 J Clin Oncol 21 2003 3972 3978
18. M.V. Pilepich, K. Winter, and C.A. Lawton Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma - Long-term results of Phase III RTOG 85-31 Int J Radiat Oncol Biol Phys 61 2005 1285 1290
19. S.A. Rosenthal, K. Bae, and K.J. Pienta Phase III multi-institutional trial of adjuvant chemotherapy with paclitaxel, estramustine, and oral etoposide combined with long-term androgen suppression therapy and radiotherapy versus long-term androgen suppression plus radiotherapy alone for high-risk prostate cancer: Preliminary toxicity analysis of RTOG 99-02 Int J Radiat Oncol Biol Phys 73 2009 672 678