Phase I study of paclitaxel in combination with a multidrug resistance modulator, PSC 833 (valspodar), in refractory malignancies

Journal of Clinical Oncology

Volumn 18, Issue 5, 2000, Pages 1124-1134

  Fracasso, Paula M ^a   Westerveldt, Peter ^a   Fears, Carole A ^a   Rosen, D Marc ^a   Zuhowski, Eleanor G ^a   Cazenave, Lorraine A ^a   Litchman, Manuel ^a   Egorin, Merrill J ^a  

^a UNIVERSITY OF MARYLAND GREENEBAUM CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PACLITAXEL; VALSPODAR;

ADULT; AGED; ARTICLE; BONE MARROW SUPPRESSION; CANCER; CLINICAL ARTICLE; DRUG BLOOD LEVEL; FEMALE; HUMAN; MALE; MULTIDRUG RESISTANCE; NEUTROPENIA; PRIORITY JOURNAL; THROMBOCYTOPENIA; TREATMENT FAILURE;

EID: 0033993578     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/jco.2000.18.5.1124     Document Type: Article

References (30)

1. Gottesman MM, Pastan I: Biochemistry of multidrug resistance mediated by the multidrug transporter. Ann Rev Biochem 62:385-427, 1993
2. Goldstein LJ, Pastan I, Gottesman MM: Multidrug resistance in human cancer. Crit Rev Oncol Hematol 12:243-253, 1992
3. Ford JM, Yang, J-M, Hait WN: P-glycoprotein-mediated multidrug resistance: Experimental and clinical strategies for its reversal, in Hait WN (ed): Drug Resistance. Norwell, MA, Kluwer Academic Publishers, 1996, pp 3-38
4. Twentyman PR: Cyclosporins as drug resistance modifiers. Biochem Pharmacol 43:109-117, 1992
5. Gaveriaux C, Boesch D, Jachez B, et al: SDZ PSC 833, a non-immunosuppressive cyclosporin analog, is a very potent multidrug-resistance modifier. J Cell Pharmacol 2:225-234, 1991
6. Boesch D, Muller K, Pourtier-Manzanedo A, et al: Restoration of daunomycin retention in multidrug-resistant P388 cells by submicromolar concentrations of SDZ PSC 833, a nonimmunosuppressive cyclosporin derivative. Exp Cell Res 196:26-32, 1991
7. Twentyman PR, Bleehen NM: Resistance modification by PSC-833, a novel non-immunosuppressive cyclosporin A. Eur J Cancer 27:1639-1642, 1991
8. Keller RP, Altermatt HJ, Nooter K, et al: SDZ PSC 833, a non-immunosuppressive cyclosporine: Its potency in overcoming P-glycoprotein-mediated multidrug resistance of murine leukemia. Int J Cancer 50:593-597, 1992
9. Boesch D, Gaveriaux C, Jachez B, et al: In vivo circumvention of P-glycoprotein-mediated multidrug resistance of tumor cells with SDZ PSC 833. Cancer Res 57:4226-4233, 1991
10. Boote DJ, Dennis IF, Twentyman RJ, et al: Phase I study of etoposide with SDZ PSC 833 as a modulator of multidrug resistance in patients with cancer. J Clin Oncol 14:610-618, 1996
11. Collins HL, Fisher GA, Hausdorff J, et al: Phase I trial of paclitaxel in combination with SDZ PSC 833, a multidrug resistance modulator. Proc Am Soc Clin Oncol 14:181a, 1995 (abstr 406)
12. Fracasso PM, Fisher GA, Wiehl JG, et al: Phase I trial of paclitaxel (Taxol® and SDZ PSC 833 in patients with solid tumors. Proc Am Soc Clin Oncol 14:486a, 1995 (abstr 1585)
13. Glantz MJ, Choy H, Kearns CM, et al: Paclitaxel disposition in plasma and central nervous systems of humans and rats with brain tumors. J Natl Cancer Inst 87:1077-1081, 1995
14. D'Argenio DZ, Schumitzky A: A program package for simulation and parameter estimation in pharmacokinetic systems. Comput Programs Biomed 9:115-134, 1979
15. Gianni L, Kearns CM, Giani A, et al: Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans. J Clin Oncol 13:180-190, 1995
16. Kearns CM, Gianni L, Egorin MJ: Paclitaxel pharmacokinetics and pharmacodynamics. Semin Oncol 22:16-23, 1995 (suppl 6)
17. Levitt D, Pearce T: SDZ PSC 833 Investigator's Brochure. Basel, Switzerland, Sandoz Pharma Ltd, 1994
18. Covelli A: SDZ PSC 833 Investigator's Brochure. Basel, Switzerland, Sandoz Pharma Ltd, 1996
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 12:241-248, 1994
20. Aisner J, Belani CP, Kearns C, et al: Feasibility and pharmacokinetics of paclitaxel, carboplatin, and concurrent radiotherapy for regionally advanced squamous cell carcinoma of the head and neck and for regionally advanced non-small cell lung cancer. Semin Oncol 22:17-21, 1995 (suppl 12)
21. Sivasailam S, Aisner J, Castellanos P, et al: Pilot trial of weekly carboplatin (C) and paclitaxel (P) combined with radiation therapy (RT) in patients (pts) with unresectable head and neck squamous cell carcinoma (SCCHN). Proc Am Soc Clin Oncol 16:391a, 1997 (abstr 1395)
22. Fisher GA, Sikic B: Clinical studies with modulators of multidrug resistance. Hematol Oncol Clin North Am 9:363-383, 1995
23. Bradshow DM, Arceci RJ: Clinical relevance of transmembrane drug efflux as a mechanism of multidrug resistance. J Clin Oncol 16:3674-3690, 1998
24. Yahanda AM, Adler KM, Fisher GA, et al: Phase I trial of etoposide with cyclosporine as a modulator of multidrug resistance. J Clin Oncol 10:1624-1634, 1992
25. Lum BL, Kaubisch S, Yahanda AM, et al: Alteration of etoposide pharmacokinetics and pharmacodynamics by cyclosporine in a phase I trial to modulate multidrug resistance. J Clin Oncol 10:1635-1642, 1992
26. Erlichman C, Moore M, Thiessen JJ, et al: Phase I pharmacokinetic study of cyclosporin A combined with doxorubicin. Cancer Res 53:4837-4842, 1993
27. Bartlett NL, Lum BL, Fisher GA, et al: Phase I trial of doxorubicin with cyclosporine as a modulator of multidrug resistance. J Clin Oncol 12:835-842, 1994
28. Giaccone G, Linn SC, Welink J, et al: A dose-finding and pharmacokinetic study of reversal of multidrug resistance with SDZ PSC 833 in combination with doxorubicin in patients with solid tumors. Clin Cancer Res 3:2005-2015, 1997
29. Rowinsky EK: The development and clinical utility of the taxane class of antimicrotubule chemotherapy agents. Ann Rev Med 48:353-374, 1997
30. Fields A, Hochster H, Runowicz C, et al: SDZ PSC 833/paclitaxel in paclitaxel refractory ovarian carcinoma: A phase II trial with renewed responses. Proc Am Soc Clin Oncol 16:351a, 1997 (abstr 1254)