A randomized, double-blind, placebo-controlled, Phase II study with and without enzastaurin in combination with docetaxel-based chemotherapy in patients with castration-resistant metastatic prostate cancer

Investigational New Drugs

Volumn 31, Issue 4, 2013, Pages 1044-1050

  Dreicer, Robert ^a   Garcia, Jorge ^a   Rini, Brian ^a   Vogelzang, Nicholas ^b   Srinivas, Sandy ^c   Somer, Bradley ^d   Shi, Peipei ^e   Kania, Marek ^e   Raghavan, Derek ^a,f  

^a TAUSSIG CANCER INSTITUTE   (United States)

^b Developmental Therapeutics Committee and Co Chair of the Genitourinary Committee   (United States)

^c STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^d WEST CLINIC   (United States)

^e ELI LILLY AND COMPANY   (United States)

^f LEVINE CANCER INSTITUTE   (United States)

Author keywords

Docetaxel; Enzastaurin; Prostate cancer; Prostate specific antigen

Indexed keywords

DOCETAXEL; ENZASTAURIN; PLACEBO; PREDNISONE;

ADULT; AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CASTRATION RESISTANT PROSTATE CANCER; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HUMAN; HYPERGLYCEMIA; LOADING DRUG DOSE; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SIDE EFFECT; SURVIVAL TIME; THROMBOSIS;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DOUBLE-BLIND METHOD; HUMANS; INDOLES; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; PLACEBOS; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; TAXOIDS; TREATMENT OUTCOME;

EID: 84880922571     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-013-9940-0     Document Type: Article

References (17)

1. Kantoff P, Higano C, Shore N et al (2010) Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 363:411-422
2. de Bono J, Oudard S, Ozguroglu M et al. (2010) Cabazitaxel or mitoxantrone with prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel: Final results of a multinational phase III trial (TROPIC). J Clin Oncol 28 (Suppl 15):abstract 4508
3. de Bono J, Logothetis C, Molina A et al (2011) Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 364:1995-2005
4. Scher H, Fizazi K, Saad F et al (2012) Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 367:1187-1197
5. Tannock I, de Wit R, Berry W et al (2004) Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351:1502-1512
6. Berthold D, Pond G, Roessner M et al (2008) Treatment of hormone-refractory prostate cancer with docetaxel or mitoxantrone: relationships between prostate-specific antigen, pain, and quality of life, response and survival in the TAX-327 study. Clin Cancer Res 14:2763-2767
7. Kelly W, Halabi S, Carducci M et al (2012) Randomized, double-blind, placebo-controlled phase III trial comparing docetaxel and prednisone with or without bevacizumab in men with metastatic castration-resistant prostate cancer: CALGB 90401. J Clin Oncol 30:1534-1540
8. Scher H, Jia X, Chi K et al (2011) Randomized, open-label phase III trial of docetaxel plus high-dose calcitriol versus docetaxel plus prednisone for patients with castration-resistant prostate cancer. J Clin Oncol 29:2191-2198
9. Jarvis W, Grant S (1999) Protein kinase C targeting in antineoplastic treatment strategies. Invest New Drugs 17:227-240
10. Parker P, Murray-Rust J (2004) PKC at a glance. J Cell Sci 117:131-132
11. Graff J, McNulty A, Hanna K et al (2005) The protein kinase Cbeta-selective inhibitor, enzastaurin (LY317615.HCl), suppresses signaling through the AKT pathway, induces apoptosis, and suppresses growth of human colon cancer and glioblastoma xenografts. Cancer Res 65:7462-7469
12. Dreicer R, Garcia J, Hussain M et al (2011) Oral enzastaurin in prostate cancer: a two-cohort phase II trial in patients with PSA progression in the non-metastatic castrate state and following docetaxel-based chemotherapy for castrate metastatic disease. Invest New Drugs 29:1441-1448
13. Small E, Demkow T, Gerritsen W et al. (2009) A phase III trial of GVAX immunotherapy for prostate cancer in combination with docetaxel versus docetaxel plus prednisone in symptomatic, castration-resistant prostate cancer. In American Society of Clinical Oncology - Genitourinary Cancers Symposium 2009, Orlando, FL:abstract 7
14. Chen Y, LaCasce A (2009) Enzastaurin. Expert Opin Investig Drugs 17:939-944
15. Wick W, Puduvalli, VK Chamberlain MC, et al. Phase III Study of Enzastaurin Compared With Lomustine in the Treatment of Recurrent Intracranial Glioblastoma. J Clin Oncol 28:1168-1174
16. Ysebaert L, Morschhauser F (2011) Enzastaurin hydrochloride for lymphoma: reassessing the results of clinical trials in light of recent advances in the biology of B-cell malignancies. Expert Opin Investig Drugs 20:1167-1174, Enzastaurin hydrochloride for lymphoma: reassessing the results of clinical trials in light of recent advances in the biology of B-cell malignancies
17. Galanis E, Buckner JC (2010) Enzastaurin in the Treatment of Recurrent Glioblastoma: A Promise That Did Not Materialize. J Clin Oncol 28:1097-1098