A phase I safety and pharmacologic study of a twice weekly dosing regimen of the oral taxane BMS-275183

Clinical Cancer Research

Volumn 13, Issue 13, 2007, Pages 3906-3912

  Bröker, Linda E ^a   Veltkamp, Stephan A ^b   Heath, Elisabeth I ^c   Kuenen, Bart C ^a   Gall, Helen ^a   Astier, Ludovic ^d   Parker, Susan ^d   Kayitalire, Louis ^d   Lorusso, Patricia M ^c   Schellens, Jan H M ^b,e   Giaccone, Giuseppe ^a  

^a VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^b ANTONI VAN LEEUWENHOEK HOSPITAL   (Netherlands)

^c KARMANOS CANCER INSTITUTE   (United States)

^d BRISTOL MYERS SQUIBB   (United States)

^e UTRECHT UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

BMS 275183; PROSTATE SPECIFIC ANTIGEN; TAXANE DERIVATIVE; UNCLASSIFIED DRUG;

ABDOMINAL CRAMP; ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER PATIENT; CANCER THERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; EPISTAXIS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; FLATULENCE; FLUSHING; HEMATURIA; HUMAN; LUNG NON SMALL CELL CANCER; MALE; MELANOMA; MOTOR NEUROPATHY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAIL DISEASE; NAUSEA; NEUROPATHY; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; PRURITUS; QT PROLONGATION; RASH; SENSORY NEUROPATHY; SIDE EFFECT; STOMATITIS; TASTE DISORDER; THROMBOCYTOPENIA; URINARY FREQUENCY; VOMITING; XEROSTOMIA;

ADMINISTRATION, ORAL; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; BRIDGED COMPOUNDS; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; NEOPLASMS; TAXOIDS; TIME FACTORS; TREATMENT OUTCOME;

EID: 34447121324     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-06-2875     Document Type: Article

References (21)

1. Mastalerz H, Cook D, Fairchild CR, et al. The discovery of BMS-275183: an orally efficacious novel taxane. Bioorg Med Chem 2003;11:4315-23.
2. Sparreboom A, van Asperen J, Mayer U, et al. Limited oral bioavailability and active epithelial excretion of paclitaxel (Taxol) caused by P-glycoprotein in the intestine. Proc Natl Acad Sci U S A 1997;94:2031-5.
3. Trump DL, Egorin MJ, Ramesh R, et al. A new oral taxane (BMS-275183): phase I trial with evaluation of pharmacokinetics, pharmacodynamics and bioavailability [abstract]. Proc Am Soc Clin Oncol 2002;21:100a.
4. Rose WC, Long BH, Fairchild CR, Lee FY, Kadow JF. Preclinical pharmacology of BMS-275183, an orally active taxane. Clin Cancer Res 2001;7:2016-21.
5. Huizing MT, Giaccone G, van Warmerdam LJ, et al.; The European Cancer Centre. Pharmacokinetics of paclitaxel and carboplatin in a dose-escalating and dose-sequencing study in patients with non-small-cell lung cancer. J Clin Oncol 1997;15:317-29.
6. Liu G, Franssen E, Fitch MI, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997;15:110-5.
7. Sparreboom A, van Tellingen O, Nooijen WJ, Beijnen JH. Nonlinear pharmacokinetics of paclitaxel in mice results from the pharmaceutical vehicle Cremophor EL. Cancer Res 1996;56:2112-5.
8. Szebeni J, Muggia FM, Alving CR. Complement activation by Cremophor EL as a possible contributor to hypersensitivity to paclitaxel: an in vitro study. J Natl Cancer Inst 1998;90:300-6.
9. van Tellingen O, Huizing MT, Panday VR, Schellens JH, Nooijen WJ, Beijnen JH. Cremophor EL causes (pseudo-) non-linear pharmacokinetics of paclitaxel in patients. Br J Cancer 1999;81:330-5.
10. Bröker LE, de Vos FY, van Groeningen CJ, et al. Phase I trial with BMS-275183, a novel oral taxane with promising antitumor activity. Clin Cancer Res 2006;12:1760-7.
11. Cortes JE, Pazdur R. Docetaxel. J Clin Oncol 1995;13:2643-55.
12. Rowinsky EK, Donehower RC. Paclitaxel (taxol). N Engl J Med 1995;332:1004-14.
13. Williams C, Collingwood M, Simera I, Grafton C. Short versus long duration infusions of paclitaxel for any adenocarcinoma. Cochrane Database Syst Rev 2003;CD003911.
14. Mielke S, Sparreboom A, Steinberg SM, et al. Association of paclitaxel pharmacokinetics with the development of peripheral neuropathy in patients with advanced cancer. Clin Cancer Res 2005;11:4843-50.
15. Division of Cancer Treatment NCI. Guidelines for reporting of adverse drug reactions. Bethesda (MD): 1998.
16. World Health Organization Offset Publication No. 48. WHO handbook for reporting results of cancer treatment. Geneva (Switzerland): 1979.
17. Marchetti S, Pluim D, Van Tellingen O, et al. The novel orally available taxane derivative BMS-275183 is a substrate for P-glycoprotein (PgP, MDR1) and MRP2 and interacts with benzimidazole proton pump inhibitors [abstract]. Proc Am Assoc Cancer Res 2006;47:1272.
18. Huizing MT, Keung AC, Rosing H, et al. Pharmacokinetics of paclitaxel and metabolites in a randomized comparative study in platinum-pretreated ovarian cancer patients. J Clin Oncol 1993;11:2127-35.
19. Schiller JH, Storer B, Tutsch K, et al. Phase I trial of 3-hour infusion of paclitaxel with or without granulocyte colony-stimulating factor in patients with advanced cancer. J Clin Oncol 1994;12:241-8.
20. Goh BC, Lee SC, Wang LZ, et al. Explaining interindividual variability of docetaxel pharmacokinetics and pharmacodynamics in Asians through phenotyping and genotyping strategies. J Clin Oncol 2002;20:3683-90.
21. Henningsson A, Marsh S, Loos WJ, et al. Association of CYP2C8, CYP3A4, CYP3A5, and ABCB1 polymorphisms with the pharmacokinetics of paclitaxel. Clin Cancer Res 2005;11:8097-104.