A phase I and pharmacokinetic study of novel taxane BMS-188797 and cisplatin in patients with advanced solid tumours

British Journal of Cancer

Volumn 94, Issue 1, 2006, Pages 79-84

  Du Bois, A ^a   Jung, B ^a   Loehr, A ^a   Schaller Kranz, T ^b   Cohen, M ^b   Frickhofen, N ^a  

^a DR HORST SCHMIDT KLINIKEN   (Germany)

^b BRISTOL MYERS SQUIBB   (United States)

Author keywords

BMS 188797; Cisplatin; Taxane

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BMS 188797; CISPLATIN; PACLITAXEL DERIVATIVE; TAXANE DERIVATIVE;

ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ANEMIA; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; COLITIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DOSE RESPONSE; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG HALF LIFE; DRUG INFUSION; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; HEARING DISORDER; HUMAN; HYPERSENSITIVITY; HYPERSENSITIVITY REACTION; INFECTION; LEUKOPENIA; MALE; MOTOR NEUROPATHY; MYALGIA; NAUSEA; NEUROPATHY; NEUTROPENIA; OVARY CARCINOMA; PERITONITIS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; REMISSION; SENSORY NEUROPATHY; SEPSIS; SIDE EFFECT; SOLID TUMOR; STANDARDIZATION; STEADY STATE; STOMATITIS; THROMBOCYTOPENIA; TIME; UTERINE CERVIX CARCINOMA;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CISPLATIN; FEMALE; HALF-LIFE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; TAXOIDS;

EID: 30644474901     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6602886     Document Type: Article

References (18)

1. Advani R, Fisher GA, Cho CD, Lum BL, Yuen A, Jambalos C, Grekowicz A, Bulanhagui CA, Chen T, Cunningham M, Gallant G, Gollerkeri A, Guld T, Cohen M, Guo R, Sikic BI (2002) Phase I study of weekly BMS-188797 in combination with carboplatin in patients with advanced malignancies. Proc Am Soc Clin Oncol 21: 101a (abstract 402)
2. Advani R, Fisher GA, Lum BL, Jambalos C, Cho CD, Cohen M, Gollerkeri A, Sikic BI (2003) Phase I and pharmacokinetic study of BMS-188797, a new taxane analog, administered on a weekly schedule in patients with advanced malignancies. Clin Cancer Res 9: 5187-5194
3. Bilenker JH, Stevenson JP, Gallagher ML, Vaughn D, Cohen MB, O'Dwyer PJ (2004) Phase I trial of the novel taxane BMS-184476 administered in combination with carboplatin every 21 days. Br J Cancer 91: 213-218
4. Choy H (2001) Taxanes in combined modality therapy for solid tumors. Crit Rev Oncol Hematol 37: 237-247
5. du Bois A, Lueck HJ, Meier W, Adams HP, Mobus V, Costa S, Bauknecht T, Richter B, Warm M, Schroder W, Olbricht S, Nitz U, Jackisch C, Emons G, Wagner U, Kuhn W, Pfisterer J, for the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group (2003) A randomized clinical trial of cisplatin/paclitaxel versus carboplatin/paclitaxel as first-line treatment of ovarian cancer. J Natl Cancer Inst 95: 1320-1329
6. Gibaldi M, Perrier D (1982) Noncompartmental analysis based on statistical moment theory. In: M Dekker (ed) Pharmacokinetics 2nd edn, 409-417. New York, NY: Marcel-Dekker
7. Goldstein LG, Vaders L, Rogatko A, Bulanhagui C, Choe S, Tarby C, Sonnichsen D, Gustafson N, Gallant G (2001) Phase I Study of BMS-188797, a new taxane analog, given weekly in patients with advanced malignancies. Proc Am Soc Clin Oncol 20: 866 (abstract 2093)
8. Neijt JP, Engelholm SA, Tuxen MK, Sorensen PG, Hansen M, Sessa C, de Swart CA, Hirsch FR, Lund B, van Houwelingen HC (2000) Exploratory phase III study of paclitaxel and cisplatin versus paclitaxel and carboplatin in advanced ovarian cancer. J Clin Oncol 18: 3084-3092
9. Piccart MJ, Bertelsen K, James K, Cassidy J, Mangioni C, Simonsen E, Stuart G, Kaye S, Vergote I, Blom R, Grimshaw R, Atkinson RJ, Swenerton KD, Trope C, Nardi M, Kaern J, Tumolo S, Timmers P, Roy JA, Lhoas F, Lindvall B, Bacon M, Birt A, Andersen JE, Zee B, Paul J, Baron B, Pecorelli S (2000) Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin- cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results. J Natl Cancer Inst 92: 699-708
10. Plummer R, Ghielmini M, Calvert P, Voi M, Renard J, Gallant G, Gupta E, Calvert H, Sessa C (2002) Phase I and pharmacokinetic study of the new taxane analog BMS-184476 given weekly in patients with advanced malignancies. Clin Cancer Res 8: 2788-2797
11. Rosati G, Riccardi F, Tucci A, De Rosa P, Pacilio G (2000) A phase II study of paclitaxel/cisplatin combination in patients with metastatic breast cancer refractory to anthracycline-based chemotherapy. Tumori 86: 207-210
12. Rose WC, Fairchild C, Lee FY (2001) Preclinical antitumor activity of two novel taxanes. Cancer Chemother Pharmacol 47: 97-105
13. Rowinsky EK, Eisenhauer EA, Chaudhry V, Arbuck SG, Donehower RC (1993) Clinical toxicities encountered with paclitaxel (Taxol). Semin Oncol 20(4 suppl 3): 1-15
14. Smit EF, van Meerbeeck JP, Lianes P, Debruyne C, Legrand C, Schramel F, Smit H, Gaafar R, Biesma B, Manegold C, Neymark N, Giaccone G, European Organization for Research and Treatment of Cancer Lung Cancer Group (2003) Three-arm randomized study of two cisplatin-based regimens and paclitaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group-EORTC 08975. J Clin Oncol 21: 3909-3917
15. Sullivan DM, Dellaportas AM, Mahany JJ, Kvols LL, Rago R, Dinwoodie WR, Lush RM, Gallant G, Bulanhagui D, Cunningham M, Choe SY, Guo R, Tarby CA, Gustafson N, Gollerkeri A (2001) A phase I of BMS-188797, a novel taxane, in combination with carboplatin administered every 21 days. Clin Cancer Res 7(Suppl): 3811s (abstract 786)
16. Sullivan DM, Rago R, Ruckdeschel JC, Dellaportas AM, Mahany JJ, Lush RM, Dalton WS, Bulanhagui D, Gupta E, Tarby C, Sonnichsen D, Gustafson N, Gallant G (2000) Phase I and pharmacokinetic study of BMS-188797, a new taxane analog, given every three weeks in patients with advanced malignancies. Clin Cancer Res 6(Suppl): 4579s (abstract 566)
17. Sun W, Stevenson JP, Gallagher ML, Vaughn D, Hahn SM, Haller DG, Cohen M, Kopit J, Gallant G, O'Dwyer PJ (2003) Phase I and pharmacokinetic trial of the novel taxane BMS-184476 administered as a 1-h intravenous infusion in combination with cisplatin every 21 days. Clin Cancer Res 9: 5221-5227
18. Thiebaut F, Tsuruo T, Hamada H, Gottesman MM, Pastan I, Willingham MC (1987) Cellular localization of the multidrug-resistance gene product P-glycoprotein in normal human tissue. Proc Natl Acad Sci USA 84: 7735-7738