A phase I and pharmacokinetic study of losoxantrone and paclitaxel in patients with advanced solid tumors

Clinical Cancer Research

Volumn 5, Issue 2, 1999, Pages 299-308

  Diab, Sami G ^a   Baker, Sharyn D ^b   Joshi, Amita ^d   Burris, Howard A ^c   Cobb, Patrick W ^c   Villalona Calero, Miguel A ^b   Eckhardt, S Gail ^b   Weiss, Geoffrey R ^a   Rodriguez, Gladys I ^b   Drengler, Ronald ^a   Kraynak, Maura ^b   Hammond, Lisa ^b   Finizio, Michael ^d   Von Hoff, Daniel D ^b   Rowinsky, Eric K ^b  

^a UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^b CTRC Institute for Drug Development   (United States)

^c BROOKE ARMY MEDICAL CENTER   (United States)

^d DUPONT COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LOSOXANTRONE; PACLITAXEL; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BONE MARROW SUPPRESSION; CARDIOTOXICITY; CLINICAL ARTICLE; CLINICAL TRIAL; DOSE RESPONSE; DRUG EFFICACY; DRUG RESPONSE; DRUG SCREENING; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; PRIORITY JOURNAL; SOLID TUMOR; THROMBOCYTOPENIA;

ADULT; AGED; ANTHRAQUINONES; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEASIBILITY STUDIES; FOLLOW-UP STUDIES; HEART FAILURE, CONGESTIVE; HUMANS; IMMUNOSUPPRESSION; MIDDLE AGED; NAUSEA; NEOPLASMS; PACLITAXEL; PYRAZOLES; PYRAZOLONES; TREATMENT OUTCOME;

EID: 0033048531     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (24)

1. Judson, I. R. Anthrapyrazoles: true successors to the anthracyclines? Anti-Cancer Drugs, 2: 223-231, 1991.
2. Doroshow, J. H. Prevention of doxorubicin-induced killing of MCF-7 human breast cancer cells by oxygen radical scavengers and iron chelating agents. Biochem. Biophys. Res. Commun., 135: 330-335, 1986.
3. Doroshow, J. H., and Davies, K. J. Redox cycling of anthracyclines by cardiac mitochondria. II. Formation of superoxide anion, hydrogen peroxide, and hydroxyl radical. J. Biochem., 261: 3068-3074, 1986.
4. Showalter, H. D., Johnson, J. L., Hoftiezer, J. M., Turner, W. R., Werbel, L. M., Leopold, W. R., Shillis, J. L., Jackson, R. C., and Elslager, E. F. Anthrapyrazole anticancer agents. Synthesis and structure-activity relationships against murine leukemias. J. Med. Chem., 30: 121-131, 1987.
5. Graham, M. A., Newell, D. R., Butler, J., and Hoey, B. The effect of the anthrapyrazole antitumour agent CI941 on rat liver microsome and cytochrome P-450 reductase mediated free radical processes. Inhibition of doxorubicin activation in vitro. Biochem. Pharmacol., 36: 3345-3351, 1987.
6. Fisher, G. R., and Patterson, L. H. Lack of involvement of reactive oxygen in the cytotoxicity of mitoxantrone, CI941 and ametantrone in MCF-7 cells: comparison with doxorubicin. Cancer Chemother. Pharmacol., 30: 451-458, 1992.
7. Fry, D. W., Boritzki, T. J., Besserer, J. A., and Jackson, R. C. In vitro DNA strand scission and inhibition of nucleic acid synthesis in L1210 leukemia cells by a new class of DNA complexers, the anthra[1,9-cd]pyrazol-6(2H)-ones (anthrapyrazoles). Biochem. Pharmacol., 34: 3499-3508, 1985.
8. Leteurtre, F., Kohlhagen, G., Paull, K. D., and Pommier, Y. Topoisomerase II inhibition and cytotoxicity of the anthrapyrazoles DuP 937 and DuP 941 (losoxantrone) in the National Cancer Institute preclinical antitumor drug discovery screen. J. Natl. Cancer Inst. (Bethesda), 86: 1239-1244, 1994.
9. Leopold, W. R., Nelson, J. M., Plowman, J., and Jackson, R. C. Anthrapyrazoles, a new class of intercalating agents with high-level, broad spectrum activity against murine tumors. Cancer Res., 45: 5532-5539, 1985.
10. Dexter, D. L., Diamond, M., Creveling, J., and Chen, S-F. Chemotherapy of mammary carcinomas arising in ras transgenic mice. Invest. New Drugs, 11: 161-168, 1993.
11. Foster, B. J., Newell, D. R., Graham, M. A., Gumbrell, L. A., Jenns, K. E., Kaye, S. B., and Calvert, A. H. Phase I trial of the anthrapyrazole CI-941: prospective evaluation of a pharmacokinetically guided dose-escalation. Eur. J. Cancer, 28: 463-469, 1992.
12. Talbot, D. C., Smith, I. E., Mansi, J. L., Judson, I., Calvert, A. H., and Ashley, S. E. Anthrapyrazole CI941: a highly active new agent in the treatment of advanced breast cancer. J. Clin. Oncol., 9: 2141-2147, 1991.
13. Calvert, H., Smith, I., Jones, A., ten Bokkel Huinink, W., Hedley, D., Francher, D., and Azarina, N. Phase II study of losoxantrone in previously treated and untreated patients with advanced breast cancer (CA). Proc. Am. Soc. Clin. Oncol., 13: 71, 1994.
14. Gianni, L., Munzone, E., Capri, G., Fulfaro, F., Tarenzi, E., Villani, F., Spreafico, C., Laffranchi, A., Caraceni, A., Martini, C., Stefanelli, M., Valagussa, P., and Bonadonna, G. Paclitaxel by 3 hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer: high antitumor efficacy and cardiac effects in a dose-finding and sequence-finding study. J. Clin. Oncol., 13: 2688-2699, 1995.
15. Gianni, L., Vigano, L., Locatelli, A., Capri, G., Giani, A., Tarenzi, E., and Bonadonna, G. Human pharmacokinetic characterization and in vitro study of the interaction between doxorubicin and paclitaxel in patients with breast cancer. J. Clin. Oncol., 15: 1906-1915, 1997.
16. Seidman, A. D., Tiersten, A., Hudis, C., Gollub, M., Barren, S., Yao, T. J., Lepore, J., Gilewski, T., Currie, V., Crown, J., Hakes, T., Baselga, J., Sklarin, N., Moynihan, M., Tong, W., Egorin, M., Kearns, C., Springs, D., and Norton, L. Phase II trial of paclitaxel by 3-hour infusion as initial and salvage chemotherapy for metastatic breast cancer. J. Clin. Oncol., 13: 2575-2581, 1995.
17. Nabholtz, J. M., Gelmon, K., Bontenbal, M., Spielmann, M., Catimel, G., Conte, P., Klaassen, U., Namer, M., Bonneterre, J., Fumoleau, P., and Winograd, B. Multicenter, randomized comparative study of two doses of paclitaxel in patients with metastatic breast cancer. J. Clin. Oncol., 14: 1858-1867, 1996.
18. Huizing, M. T., Keung, A. C., Rosing, H., van der Kuij, V., ten Bokkel Huinink, W. W., Mandjes, I. M., Dubbelman, A. C., Pinedo, H. M., and Beijnen, J. H. Pharmacokinetics of paclitaxel and metabolites in a randomized comparative study in platinum-pretreated ovarian cancer patients. J. Clin. Oncol., 11: 2127-2135, 1993.
19. Graham, M. A., Newell, D. R., and Calvert, A. H. Determination of the anthrapyrazole anticancer drug CI-941 in plasma and urine by solid-phase extraction and high-performance liquid chromatography. J. Chromatogr. A., 491: 253-261, 1989.
20. Gibaldi, M., and Perrier, D. Pharmacokinetics. New York: Marcel Dekker, 1982.
21. Kaufman, P. A., Harris, R., Skillings, J., Walde, D., Hong, A., Verma, S., Guevin, R., Joseph, J., and Finizio, M. Losoxantrone and paclitaxel versus paclitaxel in patients with metastatic breast cancer: a Phase III randomized study. Breast Cancer Res. Treat., 46: 1, 1997.
22. Sparano, J. A., Hu, P., Rao, R. M., Falkson, C. I., Wolff, A. C., and Wood, W. C. Phase II trial of Doxorubicin plus paclitaxel plus G-CSF in metastatic breast cancer (MBC): an Eastern Cooperative Oncology Group Study (E4195). Breast Cancer Res. Treat., 46: 1, 1997.
23. Holmes, F. A., Madden, T., Newman, R. A., Valero, V., Theriault, R. L., Fraschini, G., Walters, R. S., Booser, D. J., Buzdar, A. U., Willey, J., and Hortobagyi, G. N. Sequence-dependent alteration of doxorubicin pharmacokinetics by paclitaxel in a Phase I study of paclitaxel and doxorubicin in patients with metastatic breast cancer. J. Clin. Oncol., 14: 2713-2721, 1996.
24. Schiller, J. H., Storer, B., Tutsch, K., Arzoomanian, R., Alberti, D., and Feierabend Spriggs, D. 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.