A phase i study of bortezomib, etoposide and carboplatin in patients with advanced solid tumors refractory to standard therapy

Investigational New Drugs

Volumn 27, Issue 1, 2009, Pages 53-62

  Lieu, Christopher ^a   Chow, Laura ^a   Pierson, A Scott ^a   Eckhardt, S Gail ^a,b   O'Bryant, Cindy L ^a   Morrow, Mark ^a   Tran, Zung Vu ^a   Wright, John J ^c   Gore, Lia ^a  

^a UNIVERSITY OF COLORADO   (United States)

^b CHILDREN S HOSPITAL COLORADO   (United States)

^c EPN   (United States)

Author keywords

Bortezomib; Combination chemotherapy; Phase I clinical trial; Proteasome inhibitor

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BASIC FIBROBLAST GROWTH FACTOR; BORTEZOMIB; CARBOPLATIN; CYCLIN DEPENDENT KINASE 2; ENDOTHELIAL LEUKOCYTE ADHESION MOLECULE 1; ETOPOSIDE; I KAPPA B; PADGEM PROTEIN; PROTEIN P21; PROTEIN P27; VASCULOTROPIN; ANTINEOPLASTIC AGENT; BORONIC ACID DERIVATIVE; PYRAZINE DERIVATIVE; TUMOR MARKER;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ALOPECIA; ANEMIA; ANGIOGENESIS; ANGIOSARCOMA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTROCYTOMA; BREAST ADENOCARCINOMA; CANCER GROWTH; CLINICAL ARTICLE; CLINICAL TRIAL; COLON CARCINOMA; CONSTIPATION; DIARRHEA; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; EDEMA; ENDOMETRIUM CARCINOMA; ESOPHAGUS CARCINOMA; EWING SARCOMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; GERM CELL TUMOR; HEAD AND NECK CARCINOMA; HUMAN; HYPERBILIRUBINEMIA; HYPOALBUMINEMIA; HYPOKALEMIA; HYPONATREMIA; IMMUNOHISTOCHEMISTRY; KIDNEY CARCINOMA; LEIOMYOSARCOMA; LUNG NON SMALL CELL CANCER; MALE; MAXIMUM TOLERATED DOSE; MELANOMA; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; OVARY CARCINOMA; PANCREAS CARCINOMA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SIDE EFFECT; SOLID TUMOR; STOMACH CARCINOMA; THROMBOCYTOPENIA; VOMITING; CHEMICALLY INDUCED DISORDER; DOSE RESPONSE; DRUG ADMINISTRATION; MIDDLE AGED; NEOPLASM;

ADULT; AGED; ANEMIA; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BORONIC ACIDS; CARBOPLATIN; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; ETOPOSIDE; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NAUSEA; NEOPLASMS; NEUTROPENIA; PYRAZINES; THROMBOCYTOPENIA; TUMOR MARKERS, BIOLOGICAL;

EID: 62749089391     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10637-008-9154-z     Document Type: Article

References (42)

1. MA Read AS Neish FW Luscinskas 1995 The proteasome pathway is required for cytokine-induced endothelial-leukocyte adhesion molecule expression Immunity 2 493 506 doi:10.1016/1074-7613(95)90030-6
2. I Zavrski C Jakob P Schmid 1995 Proteasome: an emerging target for cancer therapy Anticancer Drugs 16 475 481 doi:10.1097/00001813-200506000-00002
3. AL Goldberg 1995 Functions of the proteasome: the lysis at the end of the tunnel Science 268 522 523 doi:10.1126/science.7725095
4. PJ Elliott JS Ross 2001 The proteasome: a new target for novel drug therapies Am J Clin Pathol 116 637 646 doi:10.1309/44HW-5YCJ-FLLP-3R56
5. CC Li RM Dai DL Longo 1995 Inactivation of NF-kappa B inhibitor I kappa B alpha: ubiquitin-dependent proteolysis and its degradation product Biochem Biophys Res Commun 215 292 301 doi:10.1006/bbrc.1995.2465
6. J Adams 2002 Proteasome inhibitors as new anticancer drugs Curr Opin Oncol 14 628 634 doi:10.1097/00001622-200211000-00007
7. J Adams 2001 Proteasome inhibition in cancer: development of PS-341 Semin Oncol 28 613 619 doi:10.1016/S0093-7754(01)90034-X (Pubitemid 33134421)
8. J Adams M Behnke S Chen 1998 Potent and selective inhibitors of the proteasome: dipeptidyl boronic acids Bioorg Med Chem Lett 8 333 338 doi:10.1016/S0960-894X(98)00029-8
9. BA Teicher G Ara R Herbst 1999 The proteasome inhibitor PS-341 in cancer therapy Clin Cancer Res 5 2638 2645 (Pubitemid 29437352)
10. J Adams 2002 Development of the proteasome inhibitor PS-341 Oncologist 7 9 16 doi:10.1634/theoncologist.7-1-9
11. R Bold 2004 Development of the proteasome inhibitor Velcade (bortezomib) in Adams J and Kauffman M Cancer Invest 22 328 329 doi:10.1081/CNV-120030223
12. RJ Bold S Virudachalam DJ McConkey 2001 Chemosensitization of pancreatic cancer by inhibition of the 26S proteasome J Surg Res 100 11 17 doi:10.1006/jsre.2001.6194
13. JC Cusack 2003 Rationale for the treatment of solid tumors with the proteasome inhibitor bortezomib Cancer Treat Rev 29 Suppl 1 21 31 doi:10.1016/S0305-7372(03)00079-3
14. SA Shah MW Potter TP McDade 2001 26S proteasome inhibition induces apoptosis and limits growth of human pancreatic cancer J Cell Biochem 82 110 122 doi:10.1002/jcb.1150
15. D Yin H Zhou T Kumagai 2005 Proteasome inhibitor PS-341 causes cell growth arrest and apoptosis in human glioblastoma multiforme (GBM) Oncogene 24 344 354 doi:10.1038/sj.onc.1208225
16. M Boccadoro G Morgan J Cavenagh 2005 Preclinical evaluation of the proteasome inhibitor bortezomib in cancer therapy Cancer Cell Int 5 18 doi:10.1186/1475-2867-5-18
17. Millenium Pharmaceuticals (2004) Velcade (bortezomib) for injection. Investigator's brochure, March 18, 2004. Millenium Pharmaceuticals, Cambridge MA, USA
18. C Aghajanian S Soignet DS Dizon 2002 A phase I trial of the novel proteasome inhibitor PS341 in advanced solid tumor malignancies Clin Cancer Res 8 2505 2511 (Pubitemid 34856332)
19. GK Dy JP Thomas G Wilding 2005 A phase I and pharmacologic trial of two schedules of the proteasome inhibitor, PS-341 (bortezomib, Velcade), in patients with advanced cancer Clin Cancer Res 11 3410 3416 doi:10.1158/1078-0432.CCR-04- 2068
20. CN Papandreou DD Daliani D Nix 2004 Phase I trial of the proteasome inhibitor bortezomib in patients with advanced solid tumors with observations in androgen-independent prostate cancer J Clin Oncol 22 2108 2121 doi:10.1200/JCO.2004.02.106
21. DJ Park HJ Lenz 2004 The role of proteasome inhibitors in solid tumors Ann Med 36 296 303 doi:10.1080/07853890410029031
22. Spano JP, Bay JO, Blay JY, Rixe O (2005) Proteasome inhibition: a new approach for the treatment of malignancies. Bull Cancer 92:E61-66, 945-952.
23. Anonymous (2003) APEX (Assessment of Proteasome inhibition for extending remissions) trial: phase III randomized, multicenter, placebo-controlled trial to evaluate the efficacy and safety of bortezomib versus dexamethasone in patients with recurrent or treatment-resistant multiple myeloma. Clin Adv Hematol Oncol 1:190
24. PG Richardson C Mitsiades 2005 Bortezomib: proteasome inhibition as an effective anticancer therapy Future Oncol 1 161 167 doi:10.1517/14796694.1.2.161
25. NB Davis DA Taber RH Ansari 2004 Phase II trial of PS-341 in patients with renal cell cancer: a University of Chicago phase II consortium study J Clin Oncol 22 115 119 doi:10.1200/JCO.2004.07.165
26. MH Shah D Young HL Kindler 2004 Phase II study of the proteasome inhibitor bortezomib (PS-341) in patients with metastatic neuroendocrine tumors Clin Cancer Res 10 6111 6118 doi:10.1158/1078-0432.CCR-04-0422
27. SN Markovic SM Geyer F Dawkins 2005 A phase II study of bortezomib in the treatment of metastatic malignant melanoma Cancer 103 2584 2589 doi:10.1002/cncr.21108
28. H Mackay D Hedley P Major 2005 A phase II trial with pharmacodynamic endpoints of the proteasome inhibitor bortezomib in patients with metastatic colorectal cancer Clin Cancer Res 11 5526 5533 doi:10.1158/1078-0432.CCR-05-0081
29. RG Maki AS Kraft K Scheu 2005 A multicenter Phase II study of bortezomib in recurrent or metastatic sarcomas Cancer 103 1431 1438 doi:10.1002/cncr.20968
30. WA Messersmith SD Baker L Lassiter 2006 Phase I trial of bortezomib in combination with docetaxel in patients with advanced solid tumors Clin Cancer Res 12 1270 1275 doi:10.1158/1078-0432.CCR-05-1942
31. PG Richardson C Mitsiades T Hideshima KC Anderson 2006 Bortezomib: proteasome inhibition as an effective anticancer therapy Annu Rev Med 57 33 47 doi:10.1146/annurev.med.57.042905.122625
32. P Meresse E Dechaux C Monneret E Bertounesque 2004 Etoposide: discovery and medicinal chemistry Curr Med Chem 11 2443 2466 (Pubitemid 39172359)
33. G Los E Verdegaal HP Noteborn 1991 Cellular pharmacokinetics of carboplatin and cisplatin in relation to their cytotoxic action Biochem Pharmacol 42 357 363 doi:10.1016/0006-2952(91)90723-I
34. J Cosaert E Quoix 2002 Platinum drugs in the treatment of non-small-cell lung cancer Br J Cancer 87 825 833 doi:10.1038/sj.bjc.6600540
35. J Glaholm L Repetto JR Yarnold 1998 Carboplatin (JM8), etoposide (VP16) and thoracic irradiation for small cell lung cancer (S.C.L.C.): an evaluation of lung toxicity Radiother Oncol 12 31 37 doi:10.1016/0167-8140(88)90190-9
36. CJ Ryan DF Bajorin 2002 Chemotherapy for good-risk germ-cell tumors Semin Urol Oncol 20 244 250 doi:10.1053/suro.2002.37208
37. PA Bunn Jr K Kelly 1998 New chemotherapeutic agents prolong survival and improve quality of life in non-small cell lung cancer: a review of the literature and future directions Clin Cancer Res 4 1087 1100 (Pubitemid 28213318)
38. SM Russo JE Tepper AS Baldwin Jr 2001 Enhancement of radiosensitivity by proteasome inhibition: implications for a role of NF-kappaB Int J Radiat Oncol Biol Phys 50 183 193 doi:10.1016/S0360-3016(01)01446-8
39. N Mitsiades CS Mitsiades PG Richardson 2003 The proteasome inhibitor PS-341 potentiates sensitivity of multiple myeloma cells to conventional chemotherapeutic agents: therapeutic applications Blood 101 2377 2380 doi:10.1182/blood-2002-06-1768
40. T Fujita K Washio D Takabatake 2005 Proteasome inhibitors can alter the signaling pathways and attenuate the P-glycoprotein-mediated multidrug resistance Int J Cancer 117 670 682 doi:10.1002/ijc.21063
41. AH Calvert DR Newell LA Gumbrell 1989 Carboplatin dosage: prospective evaluation of a simple formula based on renal function J Clin Oncol 7 1748 1756 (Pubitemid 19272848)
42. American Society of Clinical Oncology 1994 Recommendations for the use of hematopoietic colony-stimulating factors: evidence-based, clinical practice guidelines J Clin Oncol 12 2471 2508