A Phase 1 clinical study of temsirolimus (CCI-779) in Japanese patients with advanced solid tumors

Japanese Journal of Clinical Oncology

Volumn 40, Issue 8, 2010, Pages 732-738

  Fujisaka, Yasuhito ^a   Yamada, Yasuhide ^a   Yamamoto, Noboru ^a   Horiike, Atsushi ^a   Tamura, Tomohide ^a  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

Author keywords

Advanced solid tumor; CCI 779; Phase 1 study; Temsirolimus

Indexed keywords

DIPHENHYDRAMINE; RAPAMYCIN; TEMSIROLIMUS;

ADULT; ADVANCED CANCER; AGED; ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; COLON CANCER; COLORECTAL CANCER; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG ERUPTION; DRUG FATALITY; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSGEUSIA; EPISTAXIS; FEMALE; FLUSHING; HEART SUPRAVENTRICULAR ARRHYTHMIA; HEMATOCRIT; HUMAN; HYPERCHOLESTEROLEMIA; HYPERGLYCEMIA; HYPERTENSION; HYPERTRIGLYCERIDEMIA; HYPOPHOSPHATEMIA; KIDNEY CARCINOMA; LEUKOCYTE; LUNG INFECTION; LUNG NON SMALL CELL CANCER; LUNG SMALL CELL CANCER; LYMPHOCYTE; MALAISE; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MONOCYTE; NAIL DISEASE; NAUSEA; NEUTROPHIL COUNT; ONYCHIA; PHARYNGITIS; PHASE 1 CLINICAL TRIAL; PHLEBITIS; RECOMMENDED DRUG DOSE; SIDE EFFECT; SOLID TUMOR; SOMNOLENCE; STOMATITIS; THROMBOCYTE; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT PLANNING;

ADULT; AGED; ANTI-ALLERGIC AGENTS; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; CARCINOMA, RENAL CELL; COLORECTAL NEOPLASMS; DIARRHEA; DIPHENHYDRAMINE; DISORDERS OF EXCESSIVE SOMNOLENCE; DRUG ADMINISTRATION SCHEDULE; DRUG ERUPTIONS; FEVER; HUMANS; HYPERGLYCEMIA; HYPERTRIGLYCERIDEMIA; HYPOPHOSPHATEMIA; INFUSIONS, INTRAVENOUS; INTESTINAL PERFORATION; KIDNEY NEOPLASMS; LUNG NEOPLASMS; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; NEUTROPENIA; PREMEDICATION; SIROLIMUS; STOMATITIS; TREATMENT OUTCOME;

EID: 77955265956     PISSN: 03682811     EISSN: 14653621     Source Type: Journal    
DOI: 10.1093/jjco/hyq047     Document Type: Article

References (24)

1. Brown EJ, Beal PA, Keith CT, Chen J, Shin TB, Schreiber SL. Control of p70 S6 kinase by kinase activity of FRAP in vivo. Nature 1995;377:441-6.
2. Wang SI, Puc J, Li J, Bruce JN, Cairns P, Sidransky D, et al. Somatic mutations of PTEN in glioblastoma multiforme. Cancer Res 1997;57:4183-6.
3. Cantley LC, Neel BG. New insights into tumor suppression: PTEN suppresses tumor formation by restraining the phosphoinositide 3-kinase/AKT pathway. Proc Natl Acad Sci USA 1999;96:4240-5.
4. Yu K, Toral-Barza L, Discafani C, Zhang WG, Skotnicki J, Frost P, et al. mTOR, a novel target in breast cancer: the effect of CCI-779, an mTOR inhibitor, in preclinical models of breast cancer. Endocr Relat Cancer 2001;8:249-58.
5. Dudkin L, Dilling MB, Cheshire PJ, Harwood FC, Hollingshead M, Arbuck SG, et al. Biochemical correlates of mTOR inhibition by the rapamycin ester CCI-779 and tumor growth inhibition. Clin Cancer Res 2001;7:1758-64.
6. Neshat MS, Mellinghoff IK, Tran C, Stiles B, Thomas G, Petersen R, et al. Enhanced sensitivity of PTEN-deficient tumors to inhibition of FRAP/mTOR. Proc Natl Acad Sci USA 2001;98:10314-9.
7. Grunwald V, DeGraffenried L, Russel D, Friedrichs WE, Ray RB, Hidalgo M. Inhibitors of mTOR reverse doxorubicin resistance conferred by PTEN status in prostate cancer cells. Cancer Res 2002;62:6141-5.
8. Geoerger B, Kerr K, Tang CB, Fung KM, Powell B, Sutton LN, et al. Antitumor activity of the rapamycin analog CCI-779 in human primitive neuroectodermal tumor/medulloblastoma models as single agent and in combination chemotherapy. Cancer Res 2001;61:1527-32.
9. Podsypanina K, Lee RT, Politis C, Hennessy I, Crane A, Puc J, et al. An inhibitor of mTOR reduces neoplasia and normalizes p70/S6 kinase activity in Pten+/-mice. Proc Natl Acad Sci USA 2001;98:10320-5.
10. DeGraffenried LA, Fulcher L, Friedrichs WE, Grunwald V, Ray RB, Hidalgo M. Reduced PTEN expression in breast cancer cells confers susceptibility to inhibitors of the PI3 kinase/Akt pathway. Ann Oncol 2004;15:1510-6.
11. Japan Antibiotics Research Association. Guidelines of Clinical Evaluation of Anticancer Drugs. Tokyo: Mix 1991 (in Japanese).
12. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-16.
13. Motzer RJ, Hudes GR, Curti BD, McDermott DF, Escudier BJ, Negrier S, et al. Phase I/II trial of temsirolimus combined with interferon alfa for advanced renal cell carcinoma. J Clin Oncol 2007;25:3958-64.
14. Atkins MB, Hidalgo M, Stadler WM, Logan TF, Dutcher JP, Hudes GR, et al. Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma. J Clin Oncol 2004;22:909-18.
15. Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007;356:2271-81.
16. Chan S, Scheulen ME, Johnston S, Mross K, Cardoso F, Dittrich C, et al. Phase II study of temsirolimus (CCI-779), a novel inhibitor of mTOR, in heavily pretreated patients with locally advanced or metastatic breast cancer. J Clin Oncol 2005;23:5314-22.
17. Pandya KJ, Dahlberg S, Hidalgo M, Cohen RB, Lee MW, Schiller JH, et al. A randomized, phase II trial of two dose levels of temsirolimus (CCI-779) in patients with extensive-stage small-cell lung cancer who have responding or stable disease after induction chemotherapy: a trial of the Eastern Cooperative Oncology Group (E1500). J Thorac Oncol 2007;2:1036-41.
18. Chang SM, Wen P, Cloughesy T, Greenberg H, Schiff D, Conrad C, et al. Phase II study of CCI-779 in patients with recurrent glioblastoma multiforme. Invest New Drugs 2005;23:357-61.
19. Witzig TE, Geyer SM, Ghobrial I, Inwards DJ, Fonseca R, Kurtin P, et al. Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol 2005;23:5347-56.
20. Hess G, Herbrecht R, Romaguera J, Verhoef G, Crump M, Gisselbrecht C, et al. Phase III study to evaluate temsirolimus compared with investigator's choice therapy for the treatment of relapsed or refractory mantle cell lymphoma. J Clin Oncol 2009;27:3822-9.
21. Wyeth Pharmaceuticals Inc. Toriselw full prescribing information. 2007. http://www.fda.gov/cder/foi/label/2007/022088lbl.pdf.
22. Raymond E, Alexandre J, Faivre S, Vera K, Materman E, Boni J, et al. Safety and pharmacokinetics of escalated doses of weekly intravenous infusion of CCI-779, a novel mTOR inhibitor, in patients with cancer. J Clin Oncol 2004;22:2336-47.
23. Hidalgo M, Buckner JC, Erlichman C, Pollack MS, Boni JP, Dukart G, et al. A phase I and pharmacokinetic study of temsirolimus (CCI-779) administered intravenously daily for 5 days every 2 weeks to patients with advanced cancer. Clin Cancer Res 2006;12:5755-63.
24. European Public Assessment Report on Torisel. 2008. http://www.emea.europa.eu/humandocs/Humans/EPAR/torisel/torisel.htm (22 September 2008, date last accessed).