A phase I clinical and pharmacokinetic study of tipifarnib in combination with docetaxel in patients with advanced solid malignancies

Current Medical Research and Opinion

Volumn 23, Issue 5, 2007, Pages 991-1003

  Awada, Ahmad ^a   Zhang, Steven ^b,c   Gil, Thierry ^a   De Valeriola, Dominique ^a   Lalami, Yassine ^a   De Porre, Peter ^b,c   Piccart Gebhart, Martine J ^a  

^a JULES BORDET INSTITUTE   (Belgium)

^b JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^c Jules Bordet Institute ^*

Author keywords

Docetaxel; Farnesyltransferase inhibitor; Pharmacokinetics; Phase I; Solid cancer; Tipifarnib

Indexed keywords

AMOXICILLIN; CIPROFLOXACIN; CLAVULANIC ACID; DOCETAXEL; METHYLPREDNISOLONE; TIPIFARNIB;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ANTIBIOTIC PROPHYLAXIS; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; BONE MARROW SUPPRESSION; BREAST CANCER; CHOLELITHIASIS; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; MALE; MAXIMUM ALLOWABLE CONCENTRATION; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NAUSEA AND VOMITING; PHASE 1 CLINICAL TRIAL; PHLEBITIS; PHOTOSENSITIVITY; RASH; SINGLE DRUG DOSE; STOMATITIS; THROMBOCYTOPENIA; TREATMENT RESPONSE;

EID: 34249022680     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079907X178810     Document Type: Article

References (35)

1. End DW, Smets G, Todd AV, et al. Characterization of the antitumor effects of the selective farnesyl protein transferase inhibitor R115777 in vivo and in vitro. Cancer Res 2001;61: 131-7
2. Punt CJ, van Maanen L, Bol CJ, et al. Phase I and pharmacokinetic study of the orally administered farnesyl transferase inhibitor R115777 in patients with advanced solid tumors. Anticancer Drugs 2001;12:193-7
3. Cloughesy TF, Kuhn J, Wen P, et al. Phase II trial of R115777 (Zarnestra) in patients with recurrent glioma not taking enzyme inducing antiepileptic drugs (EIAED): a North American Brain Tumor Consortium (NABTC) report. Proc Am Soc Clin Oncol 2002;21:80a [abstract]
4. Cortes J, Albitar M, Thomas D, et al. Efficacy of the farnesyl transferase inhibitor R115777 in chronic myeloid leukemia and other hematologic malignancies. Blood 2003;101:1692-7
5. Cortes J, Garcia-Manero G, O'Brien S, et al. A phase I study of tipifarnib in combination with imatinib mesylate (IM) for patients (Pts) with chronic myeloid leukemia (CML) in chronic phase (CP) who failed IM therapy. Blood 2004;104:176 [abstract]
6. Gotlib J, Loh M, Lancet JE, et al. Phase I/II study of tipifarnib (ZARNESTRA, farnesyltransferase inhibitor [FTI] R115777) in patients with myeloproliferative disorders (MPDs): interim results. Blood 2003;102:921a [abstract]
7. Gotlib J, MauroM, O'DwyerME, et al. Tipifarnib (ZARNESTRA) and Imatinib (GLEEVEC) combination therapy in patients with advanced chronic myelogenous leukemia (CML): preliminary results of a phase I study. Blood 2003;102:909a [abstract]
8. Harousseau JL, Reiffers J, Lowenberg B, et al. Zarnestra (R115777) in patients with relapsed and refractory acute myelogenous leukemia (AML): results of a multicenter phase 2 study. Blood 2003,102:176a [abstract]
9. Johnston SR, Hickish T, Ellis P, et al. Phase II study of the efficacy and tolerability of two dosing regimens of the farnesyl transferase inhibitor, R115777, in advanced breast cancer. J Clin Oncol 2003;21:2492-9
10. Karp JE, Lancet JE, Kaufmann SH, et al. Clinical and biologic activity of the farnesyltransferase inhibitor R115777 in adults with refractory and relapsed acute leukemias: a phase 1 clinical-laboratory correlative trial. Blood 2001;97:3361-9
11. Kurzrock R, Kantarjian HM, Cortes JE, et al. Farnesyltransferase inhibitor R115777 in myelodysplastic syndrome: clinical and biologic activities in the phase 1 setting. Blood 2003;102:4527-34
12. Kurzrock R, Albitar M, Cortes JE, et al. Phase II study of R115777, a farnesyl transferase inhibitor, in myelodysplastic syndrome. J Clin Oncol 2004;22:1287-92
13. Lancet JE, Gotlib J, Gojo I, et al. Tipifarnib (ZARNESTRA™) in previously untreated poor-risk AML of the elderly: updated results of a multicenter phase 2 trial. Blood 2004;104:249a [abstract]
14. Mesa RA. Tipifarnib: farnesyl transferase inhibition at a crossroads. Expert Rev Anticancer Ther 2006;6:313-9
15. Belani CP. Optimizing chemotherapy for advanced non-small cell lung cancer: focus on docetaxel. Lung Cancer 2005;50(Suppl 2):S3-8
16. Escobar PF, Rose PG. Docetaxel in ovarian cancer. Expert Opin Pharmacother 2005;6:2719-26
17. Lyseng-Williamson KA, Fenton C. Docetaxel: a review of its use in metastatic breast cancer. Drugs 2005;65:2513-31
18. Trudeau ME. Docetaxel (Taxotere): an overview of first-line monotherapy. Semin Oncol 1995;22:17-21
19. Skrzat SG, Bowden CR, End DW. Interaction of the farnesyl protein transferase inhibitor R115777 with cytotoxic chemotherapies in vitro and in vivo. Proc Am Assoc Cancer Res 1999;40:523 [abstract]
20. Engels FK, Ten Tije AJ, Baker SD, et al. Effect of cytochrome P450 3A4 inhibition on the pharmacokinetics of docetaxel. Clin Pharmacol Ther 2004;75:448-54
21. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-55
22. Zhang S, Zannikos P, Awada A, et al. Pharmacokinetics of tipifarnib after oral and intravenous administration in subjects with advanced cancer. J Clin Pharmacol 2006;46:1116-27
23. Gibaldi M, Perrier D. Pharmacokinetics. New York, NY: Marcel Dekker, 1982
24. Lebowitz PF, Eng-Wong J, Widemann BC, et al. A phase I trial and pharmacokinetic study of tipifarnib, a farnesyltransferase inhibitor, and tamoxifen in metastatic breast cancer. Clin Cancer Res 2005;11:1247-52
25. Patnaik A, Eckhardt SG, Izbicka E, et al. A phase I, pharmacokinetic, and biological study of the farnesyltransferase inhibitor tipifarnib in combination with gemcitabine in patients with advanced malignancies. Clin Cancer Res 2003;9: 4761-71
26. Baker SD, Zhao M, Lee CK, et al. Comparative pharmacokinetics of weekly and every-three-weeks docetaxel. Clin Cancer Res 2004;10:1976-83
27. Fakih MG, Creaven PJ, Ramnath N, et al. Phase I and pharmacokinetic study of weekly docetaxel, cisplatin, and daily capecitabine in patients with advanced solid tumors. Clin Cancer Res 2005;11:5942-9
28. Witta SE, Gustafson DL, Pierson AS, et al. A phase I and pharmacokinetic study of exisulind and docetaxel in patients with advanced solid tumors. Clin Cancer Res 2004;10:7229-37
29. Vici P, Belli F, Di LL, et al. Docetaxel in patients with anthracycline-resistant advanced breast cancer. Oncology 2001;60:60-5
30. Valero V, Jones SE, Von Hoff DD, et al. A phase II study of docetaxel in patients with paclitaxel-resistant metastatic breast cancer. J Clin Oncol 1998;16:3362-8
31. Muro K, Hamaguchi T, Ohtsu A, et al. A phase II study of single-agent docetaxel in patients with metastatic esophageal cancer. Ann Oncol 2004;15:955-9
32. Clark TB, Kemeny NE, Conti JA, et al. Phase II trial of docetaxel (Taxotere) for untreated advanced colorectal carcinoma. Cancer Invest 1998;16:314-8
33. Bonneterre J, Spielman M, Guastalla JP, et al. Efficacy and safety of docetaxel (Taxotere) in heavily pretreated advanced breast cancer patients: the French compassionate use programme experience. Eur J Cancer 1999;35:1431-9
34. Alexopoulos CG, Rigatos G, Efremidis AP, et al. A phase II study of the effectiveness of docetaxel (Taxotere) in women with advanced breast cancer previously treated with polychemotherapy. Hellenic Cooperative Interhospital Group in Oncology. Cancer Chemother Pharmacol 1999;44:253-8
35. Rao S, Cunningham D, de Gramont A, et al. Phase III double-blind placebo-controlled study of farnesyl transferase inhibitor R115777 in patients with refractory advanced colorectal cancer. J Clin Oncol 2004;22:3950-7