Multicenter phase II study of trabectedin in patients with metastatic castration-resistant prostate cancer

Annals of Oncology

Volumn 23, Issue 5, 2012, Pages 1234-1240

  Michaelson, M D ^a   Bellmunt, J ^b   Hudes, G R ^c   Goel, S ^d   Lee, R J ^a   Kantoff, P W ^e   Stein, C A ^d   Lardelli, P ^f   Pardos, I ^f   Kahatt, C ^f   Nieto, A ^f   Cullell Young, M ^f   Lewis, N L ^c   Smith, M R ^a  

^a MASSACHUSETTS GENERAL HOSPITAL CANCER CENTER   (United States)

^b HOSPITAL DEL MAR   (Spain)

^c FOX CHASE CANCER CENTER   (United States)

^d ALBERT EINSTEIN CANCER CENTER   (United States)

^e DANA FARBER CANCER INSTITUTE   (United States)

^f PHARMAMAR S A   (Spain)

Author keywords

Chemotherapy; Docetaxel; Prostate cancer; Second line; Trabectedin

Indexed keywords

PROSTATE SPECIFIC ANTIGEN; TRABECTEDIN;

ADULT; ADVERSE OUTCOME; AGED; ARTICLE; CANCER CHEMOTHERAPY; CASTRATION RESISTANT PROSTATE CANCER; CLINICAL EVALUATION; CONTROLLED STUDY; DISEASE MARKER; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEBRILE NEUTROPENIA; HUMAN; HYPERTRANSAMINASEMIA; MAJOR CLINICAL STUDY; MALE; METASTASIS; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA AND VOMITING; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; THROMBOCYTOPENIA;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, ALKYLATING; COHORT STUDIES; DIOXOLES; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; ORCHIECTOMY; PROSTATIC NEOPLASMS; SARCOMA; TETRAHYDROISOQUINOLINES; TREATMENT FAILURE; TREATMENT OUTCOME;

EID: 81055124701     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdr399     Document Type: Article

References (21)

1. Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin 2010; 60: 277-300.
2. IARC. GLOBOCAN 2008: Cancer Incidence, Mortality and Prevalence Worldwide (2008 Estimates). http://www-dep.iarc.fr/.
3. de Bono JS, Oudard S, Ozguroglu M et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet 2010; 376: 1147-1154.
4. Kantoff PW, Higano CS, Shore ND et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010; 363: 411-422.
5. Reid AH, Attard G, Danila DC et al. Significant and sustained antitumor activity in post-docetaxel, castration-resistant prostate cancer with the CYP17 inhibitor abiraterone acetate. J Clin Oncol 2010; 28: 1489-1495.
6. Danila DC, Morris MJ, de Bono JS et al. Phase II multicenter study of abiraterone acetate plus prednisone therapy in patients with docetaxel-treated castrationresistant prostate cancer. J Clin Oncol 2010; 28: 1496-1501.
7. Poindessous V, Koeppel F, Raymond E et al. Marked activity of irofulven toward human carcinoma cells: comparison with cisplatin and ecteinascidin. Clin Cancer Res 2003; 9: 2817-2825.
8. Rinehart KL, Gravalos LG, Faircloth G, Jimeno J. ET743: preclinical antitumor development of a marine derived natural product. Proc Am Assoc Cancer Res 1995; 36: 390.
9. Demetri GD, Chawla SP, von Mehren M et al. Efficacy and safety of trabectedin in patients with advanced or metastatic liposarcoma or leiomyosarcoma after failure of prior anthracyclines and ifosfamide: results of a randomized phase II study of two different schedules. J Clin Oncol 2009; 27: 4188-4196.
10. Bubley GJ, Carducci M, Dahut W et al. Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 1999; 17: 3461-3467.
11. Scher HI, Halabi S, Tannock I et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol 2008; 26: 1148-1159.
12. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981; 47: 207-214.
13. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989; 10: 1-10.
14. Gurtler JS, Goldstein L, Delprete S et al. Trabectedin in third line breast cancer: a multicenter, randomized, phase II study comparing two administration regimens. J Clin Oncol 2005; 23: 625; ASCO Annual Meeting Proceedings.
15. Zelek L, Yovine A, Brain E, et al. A phase II study of Yondelis (trabectedin, ET-743) as a 24-h continuous intravenous infusion in pretreated advanced breast cancer. Br J Cancer 2006; 94: 1610-1614.
16. Schurko B, Oh WK. Docetaxel chemotherapy remains the standard of care in castration-resistant prostate cancer. Nat Clin Pract Oncol 2008; 5: 506-507.
17. Pal SK, Sartor O. Phase III data for abiraterone in an evolving landscape for castration-resistant prostate cancer. Maturitas 2010; 68: 103-105.
18. D'Incalci M, Galmarini CM. A review of trabectedin (ET-743): a unique mechanism of action. Mol Cancer Ther 2010; 9: 2157-2163.
19. Schoffski P, Taron M, Jimeno J, et al. Predictive impact of DNA repair functionality on clinical outcome of advanced sarcoma patients treated with trabectedin: a retrospective multicentric study. Eur J Cancer 2011; 47: 1006-1012.
20. Jimeno J, Aracil M, Tercero JC. Adding pharmacogenomics to the development of new marine-derived anticancer agents. J Transl Med 2006; 4: 3.
21. Tercero JC, Jimeno J, Martinez N, et al. Predicting sarcoma patients response to trabectedin treatment with molecular markers detected by immunohistochemistry. In: Third AACR International Conference on Molecular Diagnostics in Cancer Therapeutic Development, Sep 22-25, Philadelphia, PA, 2008. Abstract B28, p. 44. AACR, Philadelphia, PA.