A phase I pharmacokinetic study of bexarotene with vinorelbine and cisplatin in patients with advanced non-small-cell lung cancer (NSCLC)

Cancer Chemotherapy and Pharmacology

Volumn 69, Issue 3, 2012, Pages 815-824

  Wakelee, Heather A ^a   Middleton, Gary ^b   Dunlop, David ^c   Ramlau, Rodryg ^d   Leighl, Natasha ^e   Hao, Desiree ^f   Lopez Anaya, Arturo ^g,i   Zatloukal, Petr ^h   Jacobs, Charlotte D ^a  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b ROYAL SURREY COUNTY HOSPITAL   (United Kingdom)

^c BEATSON WEST OF SCOTLAND CANCER CENTRE   (United Kingdom)

^d POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

^e PRINCESS MARGARET HOSPITAL   (Canada)

^f TOM BAKER CANCER CENTRE   (Canada)

^g EISAI INC   (United States)

^h CHARLES UNIVERSITY   (Czech Republic)

ⁱ Forest Laboratories Inc   (United States)

Author keywords

Bexarotene; Cisplatin; Non small cell lung cancer; Pharmacokinetics; Vinorelbine

Indexed keywords

ANTILIPEMIC AGENT; ATORVASTATIN; BEXAROTENE; CISPLATIN; CYTOCHROME P450 3A4; FENOFIBRATE; NAVELBINE; RETINOL;

ADVANCED CANCER; ALOPECIA; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; CANCER STAGING; CLINICAL ARTICLE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DRUG ABSORPTION; DRUG CAPSULE; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE REDUCTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; FATIGUE; FEMALE; FEVER; FLUSHING; HEADACHE; HEARING IMPAIRMENT; HUMAN; HYPERTRIGLYCERIDEMIA; INSOMNIA; LETHARGY; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; RESPIRATORY TRACT DISEASE; SIDE EFFECT; SINGLE DRUG DOSE; STEADY STATE; THORAX PAIN; TINNITUS; VOMITING;

ADMINISTRATION, ORAL; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG INTERACTIONS; FEMALE; HUMANS; HYPOLIPIDEMIC AGENTS; INFUSIONS, INTRAVENOUS; LUNG NEOPLASMS; MALE; MIDDLE AGED; RETINOID X RECEPTORS; TETRAHYDRONAPHTHALENES; VINBLASTINE;

EID: 84859757171     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-011-1771-0     Document Type: Article

References (30)

1. Andersson A, Fagerberg J, Lewensohn R, Ehrsson H (1996) Pharmacokinetics of cisplatin and its monohydrated complex in humans. J Pharm Sci 85:824-827 (Pubitemid 26269476)
2. Blumenschein GR Jr, Khuri FR, von Pawel J, Gatzemeier U, Miller WH Jr, Jotte RM, Le Treut J, Sun SL, Zhang JK, Dziewanowska ZE, Negro-Vilar A (2008) Phase III trial comparing carboplatin, paclitaxel, and bexarotene with carboplatin and paclitaxel in chemotherapy-naive patients with advanced or metastatic non-small-cell lung cancer: SPIRIT II. J Clin Oncol 26:1879-1885
3. Boehm MF, McClurg MR, Pathirana C, Mangelsdorf D, White SK, Hebert J, Winn D, Goldman ME, Heyman RA (1994) Synthesis of high specific activity [3H]-9-cis-retinoic acid and its application for identifying retinoids with unusual binding properties. J Med Chem 37:408-414 (Pubitemid 24079951)
4. Brabender J, Danenberg KD, Metzger R, Schneider PM, Lord RV, Groshen S, Tsao-Wei DD, Park J, Salonga D, Holscher AH, Danenberg PV (2002) The role of retinoid X receptor messenger RNA expression in curatively resected non-small cell lung cancer. Clin Cancer Res 8:438-443 (Pubitemid 34193962)
5. Brabender J, Metzger R, Salonga D, Danenberg KD, Danenberg PV, Holscher AH, Schneider PM (2005) Comprehensive expression analysis of retinoic acid receptors and retinoid X receptors in non-small cell lung cancer: implications for tumor development and prognosis. Carcinogenesis 26:525-530 (Pubitemid 41214140)
6. Calvert H, Judson I, van der Vijgh WJ (1993) Platinum complexes in cancer medicine: pharmacokinetics and pharmacodynamics in relation to toxicity and therapeutic activity. Cancer Surv 17:189-217
7. Chambon P (1996) A decade of molecular biology of retinoic acid receptors. Faseb J 10:940-954
8. clinicaltrials.gov (2008) NCT00411632
9. Duvic M, Hymes K, Heald P, Breneman D, Martin AG, Myskowski P, Crowley C, Yocum RC (2001) Bexarotene is effective and safe for treatment of refractory advanced-stage cutaneous T-cell lymphoma: multinational phase II-III trial results. J Clin Oncol 19:2456-2471 (Pubitemid 32391217)
10. Gauvin A, Pinguet F, Culine S, Astre C, Cupissol D, Bressolle F (2002) Blood and plasma pharmacokinetics of vinorelbine in elderly patients with advanced metastatic cancer. Cancer Chemother Pharmacol 49:48-56
11. Hermann TW, Yen WC, Tooker P, Fan B, Roegner K, Negro-Vilar A, Lamph WW, Bissonnette RP (2005) The retinoid X receptor agonist bexarotene (Targretin) synergistically enhances the growth inhibitory activity of cytotoxic drugs in non-small cell lung cancer cells. Lung Cancer 50:9-18 (Pubitemid 41297464)
12. Howell SR, Shirley MA, Grese TA, Neel DA, Wells KE, Ulm EH (2001) Bexarotene metabolism in rat, dog, and human, synthesis of oxidative metabolites, and in vitro activity at retinoid receptors. Drug Metab Dispos 29:990-998 (Pubitemid 32605914)
13. Inui N, Sasaki S, Suda T, Chida K, Nakamura H (2003) The loss of retinoic acid receptor alpha, beta and alcohol dehydrogenase3 expression in non-small cell lung cancer. Respirology 8:302-309 (Pubitemid 37163115)
14. Jehl F, Quoix E, Leveque D, Pauli G, Breillout F, Krikorian A, Monteil H (1991) Pharmacokinetic and preliminary metabolic fate of navelbine in humans as determined by high performance liquid chromatography. Cancer Res 51:2073-2076
15. Khuri FR, Lotan R (2004) Retinoids in lung cancer: friend, foe, or fellow traveler? J Clin Oncol 22:3435-3437 (Pubitemid 41103646)
16. Khuri FR, Rigas JR, Figlin RA, Gralla RJ, Shin DM, Munden R, Fox N, Huyghe MR, Kean Y, Reich SD, Hong WK (2001) Multiinstitutional phase I/II trial of oral bexarotene in combination with cisplatin and vinorelbine in previously untreated patients with advanced non-small-cell lung cancer. J Clin Oncol 19:2626-2637 (Pubitemid 32441367)
17. Leveque D, Jehl F, Quoix E, Breillout F (1992) Clinical pharmacokinetics of vinorelbine alone and combined with cisplatin. J Clin Pharmacol 32:1096-1098 (Pubitemid 23033661)
18. Mahmood I (2005) Interspecies pharmacokinetic scaling: principles and application of allometric scaling. Pine House Publishers, Maryland
19. Marquet P, Lachatre G, Debord J, Eichler B, Bonnaud F, Nicot G (1992) Pharmacokinetics of vinorelbine in man. Eur J Clin Pharmacol 42:545-547
20. Martin SJ, Bradley JG, Cotter TG (1990) HL-60 cells induced to differentiate towards neutrophils subsequently die via apoptosis. Clin Exp Immunol 79:448-453 (Pubitemid 20082275)
21. Miller VA, Benedetti FM, Rigas JR, Verret AL, Pfister DG, Straus D, Kris MG, Crisp M, Heyman R, Loewen GR, Truglia JA, Warrell RP Jr (1997) Initial clinical trial of a selective retinoid X receptor ligand, LGD1069. J Clin Oncol 15:790-795 (Pubitemid 27074250)
22. Picard E, Seguin C, Monhoven N, Rochette-Egly C, Siat J, Borrelly J, Martinet Y, Martinet N, Vignaud JM (1999) Expression of retinoid receptor genes and proteins in non-small-cell lung cancer. J Natl Cancer Inst 91:1059-1066 (Pubitemid 29293045)
23. Ramlau R, Zatloukal P, Jassem J, Schwarzenberger P, Orlov SV, Gottfried M, Pereira JR, Temperley G, Negro-Vilar R, Rahal S, Zhang JK, Negro-Vilar A, Dziewanowska ZE (2008) Randomized phase III trial comparing bexarotene (L1069-49)/cisplatin/vinorelbine with cisplatin/vinorelbine in chemotherapy-naive patients with advanced or metastatic non-small-cell lung cancer: SPIRIT I. J Clin Oncol 26:1886-1892
24. Rizvi NA, Marshall JL, Dahut W, Ness E, Truglia JA, Loewen G, Gill GM, Ulm EH, Geiser R, Jaunakais D, Hawkins MJ (1999) A phase I study of LGD1069 in adults with advanced cancer. Clin Cancer Res 5:1658-1664 (Pubitemid 29334442)
25. Rodon J, Jacobs CD, Chu Q, Rowinsky EK, Lopez-Anaya A, Takimoto CH, Wakelee HA (2011) A phase I pharmacokinetic study of bexarotene with paclitaxel and carboplatin in patients with advanced non-small cell lung cancer (NSCLC). Cancer Chemother Pharmacol. doi:10.1007/s00280-011-1770-1
26. Shirley MA, Wheelan P, Howell SR, Murphy RC (1997) Oxidative metabolism of a rexinoid and rapid phase II metabolite identification by mass spectrometry. Drug Metab Dispos 25:1144-1149 (Pubitemid 27446584)
27. Sporn MB, Roberts AB (1984) Role of retinoids in differentiation and carcinogenesis. J Natl Cancer Inst 73:1381-1387 (Pubitemid 15243581)
28. van de Merbel NC, van Veen JH, Wilkens G, Loewen G (2002) Validated liquid chromatographic method for the determination of bexarotene in human plasma. J Chromatogr B Anal Technol Biomed Life Sci 775:189-195 (Pubitemid 34756415)
29. Wakelee H, Middleton G, Dunlop D, Kelly C, Ramlau R, Leighl NB, Hao D, Zatloukal P, Loewen G, Cox K, Jacobs C (2005) Effect of bexarotene on vinorelbine and cisplatin pharmacokinetics (PK) during a Phase I study in patients with advanced non-small cell lung cancer (NSCLC). Lung Cancer 49(Suppl 2):S274 (Abstr #P-592)
30. Wakelee H, Takimoto CH, Lopez-Anaya A, Chu Q, Middleton G, Dunlop D, Ramlau R, Leighl N, Rowinsky EK, Hao D, Zatloukal P, Jacobs CD, Rodon J (2011) The effect of bexarotene on atorvastatin pharmacokinetics: results from a phase I trial of bexarotene plus chemotherapy in patients with advanced non-small cell lung cancer. Cancer Chemother Pharmacol. doi: 10.1007/s00280-011-1772-z