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

References

• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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]
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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]
   Google Scholar
• 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]
   Google Scholar
• Gotlib J, Mauro M, O’Dwyer ME, 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]
   Google Scholar
• 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]
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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]
   Google Scholar
• Mesa RA. Tipifarnib: farnesyl transferase inhibition at a crossroads. Expert Rev Anticancer Ther 2006;6:313–9
   PubMed Web of Science ®Google Scholar
• Belani CP. Optimizing chemotherapy for advanced non-small cell lung cancer: focus on docetaxel. Lung Cancer 2005;50(Suppl 2):S3–8
   PubMedGoogle Scholar
• Escobar PF, Rose PG. Docetaxel in ovarian cancer. Expert Opin Pharmacother 2005;6:2719–26
   PubMed Web of Science ®Google Scholar
• Lyseng-Williamson KA, Fenton C. Docetaxel: a review of its use in metastatic breast cancer. Drugs 2005;65:2513–31
   Google Scholar
• Trudeau ME. Docetaxel (Taxotere): an overview of first-line monotherapy. Semin Oncol 1995;22:17–21
   PubMed Web of Science ®Google Scholar
• Skrzat SG, Bowden CR, End DW. Interaction of the farnesyl protein transferase inhibitor R115777 with cytotoxic chemo-therapies in vitro and in vivo. Proc Am Assoc Cancer Res 1999;40:523 [abstract]
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Gibaldi M, Perrier D. Pharmacokinetics. New York, NY: Marcel Dekker, 1982
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Baker SD, Zhao M, Lee CK, et al. Comparative pharmacokinetics of weekly and every-three-weeks docetaxel. Clin Cancer Res 2004;10:1976–83
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Vici P, Belli F, Di LL, et al. Docetaxel in patients with anthracycline-resistant advanced breast cancer. Oncology 2001;60:60–5
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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 polychemo-therapy. Hellenic Cooperative Interhospital Group in Oncology. Cancer Chemother Pharmacol 1999;44:253–8
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar