Phase I and pharmacokinetic study of tomudex combined with 5- fluorouracil plus levofolinic acid in advanced head and neck cancer and colorectal cancer

Clinical Cancer Research

Volumn 5, Issue 12, 1999, Pages 3948-3955

  Caponigro, Francesco ^a   Avallone, Antonio ^a   McLeod, Howard ^b   Cartenì, Giacomo ^c   De Vita, Ferdinando ^d   Casaretti, Rossana ^a   Morsman, Janine ^b   Blackie, Robert ^e   Budillon, Alfredo ^a   De Lucia, Luigi ^f   Gravina, Adriano ^a   Catalano, Giuseppe ^d   Comella, Pasquale ^a   Comella, Giuseppe ^a  

^a NATIONAL CANCER INSTITUTE   (Italy)

^b UNIVERSITY OF ABERDEEN   (United Kingdom)

^c CARDARELLI HOSPITAL   (Italy)

^d FEDERICO II UNIVERSITY HOSPITAL   (Italy)

^e UNIVERSITY OF GLASGOW   (United Kingdom)

^f Ospedale Civile   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

DIHYDROPYRIMIDINE DEHYDROGENASE; FLUOROURACIL; FOLINIC ACID; RALTITREXED; SEROTONIN 3 ANTAGONIST;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; AREA UNDER THE CURVE; ARTICLE; BLOOD TOXICITY; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ACTIVITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG POTENTIATION; DRUG TOLERABILITY; ENZYME ACTIVITY; FEMALE; HEAD AND NECK CANCER; HUMAN; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; NAUSEA; NEPHROTOXICITY; PHASE 1 CLINICAL TRIAL; PHLEBITIS; PRIORITY JOURNAL; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, SQUAMOUS CELL; COLORECTAL NEOPLASMS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; HEAD AND NECK NEOPLASMS; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; QUINAZOLINES; THIOPHENES;

EID: 0033372553     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (25)

1. Herman, R. Systemic treatment of colorectal cancer. Eur. J. Cancer, 29: 583-586, 1993.
2. Jackman, A. L., Taylor, G. A., Gibson, W., Kimbell, R., Brown, M., Calvert, A. H., Judson, I. R., and Hughes, L. R. ICI D1694, a quinazoline antifolate thymidylate synthase inhibitor that is a potent inhibitor of L 1210 tumor cell growth in vitro and in vivo: a new agent for clinical study. Cancer Res., 51: 5579-5586, 1991.
3. Clarke, S. J., Hanwell, J., de Boer, M., Planting, A., Verweij, J., Walker, M., Smith, R., Jackman, A. L., Hughes, L. R., Kennealey, G. T., and Judson, I. R. Phase I trial of ZD 1694, a new folate-based thymidylate synthase inhibitor, in patients with solid tumors. J. Clin. Oncol., 14: 1495-1503, 1996.
4. Sorensen, J. M., Jordan, E., Grem, J. L., Hamilton, J. M., Arbuck,S. G., Johnston, P., Kohler, D. R., Goldspiel, B. R., and Allegra, C. J. Phase I trial of ZD 1694 (Tomudex), a direct inhibitor of thymidylate synthase. Ann. Oncol., 5 (Suppl. 5): 132, 1994.
5. Zalcberg, J. R., Cunningham, D., Van Cutsem, E., Francois, E., Schornagel, J., Adenis, A., Green, M., Iveson, A., Azob, M., and Seymour, I. ZD 1694: a novel thymidylate synthase inhibitor with substantial activity in the treatment of patients with advanced colorectal cancer. J. Clin. Oncol., 14: 716-721, 1996.
6. Cunningham, D., Zalcberg, J. R., Rath, U., Oliver, I., Van Cutsem, E., Svensson, C., Seitz, J. F., Harper, P., Kerr, D., Perez Manga, G., and the Tomudex Colorectal Cancer Study Group. Final results of a randomised trial comparing Tomudex with 5-fluorouracil plus leucovorin in advanced colorectal cancer. Ann. Oncol., 7: 961-965, 1996.
7. Pazdur, R., and Vincent, M. Raltitrexed (Tomudex) versus 5-fluorouracil and leucovorin (5-FU + LV) in patients with advanced colorectal cancer (ACC): results of a randomized, multicenter, North American trial. Proc. Am. Soc. Clin. Oncol., 16: 228, 1997.
8. Cocconi, G., Cunningham, D., Van Cutsem, E., Francois, E., Gustavsson, B., Van Hazel, G., Kerr, D., Passinger, K., and Hietschold, S. M., on behalf of the Tomudex Colorectal Cancer Study Group. Open, randomized, multicenter trial of raltitrexed versus fluorouracil plus high-dose leucovorin in patients with advanced colorectal cancer. J. Clin. Oncol., 16: 2943-2952, 1998.
9. Longo, G. S. A., Izzo, J., Chang, Y. M., Tong, W. P., Zielinski, Z., Garlick, R., Chan, T. C., and Bertino, J. R. Pretreatment of colon carcinoma cells with Tomudex enhances 5-fluorouracil cytotoxicity. Clin. Cancer Res., 4: 469-473, 1998.
10. Yan, J. M., Lu, Z. H., Shao, L. N., and Diasio, R. B. The effect of Tomudex on dihydropyrimidine dehydrogenase activity. Proc. Am. Assoc. Cancer Res., 38: 615, 1997.
11. Budillon, A., Barbarulo, D., Di Gennaro, E., Manzo, C., Comella, G., and Caponigro, F. In vitro cytotoxicity of Tomudex in combination with 5-fluorouracil and levofolinic acid in head and neck and colon cancer cell lines. Ann. Oncol., 9 (Suppl. 4): 133, 1998.
12. Wattanatorn, W., McLeod, H. L., Cassidy, J., and Kendle, K. E. High-performance liquid chromatographic assay of 5-fluorouracil in human erythrocytes, plasma, and whole blood. J. Chromat. B, 692: 233-237, 1997.
13. D'Argenio, D. Z., and Schumitzky, A. A program package for simulation and parameter estimation in pharmacokinetic systems. Comput. Prog. Biomed., 9: 115-134, 1979.
14. Harris, B. E., Song, R., Soong, S., and Diasio, R. B. Relationship between dihydropyrimidine dehydrogenase activity and plasma 5-fluorouracil levels with evidence for circadian variation of enzyme activity and plasma drug levels in cancer patients receiving 5-fluorouracil by protracted continuous infusion. Cancer Res., 50: 197-201, 1990.
15. McLeod, H. L., Sludden, J., Hardy, S. C., Lock, R. E., Hawksworth, G. M., and Cassidy, J. Autoregulation of drug metabolism by 5-fluorouracil. Eur. J. Cancer, 34: 1623-1627, 1998.
16. McLeod, H. L., Sludden, J., Murray, G. I., Keenan, R. A., Davidson, A. I., and Park, K. Characterisation of dihydropyrimidine dehydrogenase in human colorectal tumors. Br. J. Cancer, 77: 461-465, 1998.
17. Schwartz, G. K., Bertino, J. L., Kemeny, N., Saltz, L., Sugarman, A., Kelsen, D. K., Tong, W., Lowery, C., and Smith, M. Interim results of Phase I trial suggests that Tomudex (raltitrexed) may act synergistically with 5-fluorouracil in patients with advanced colorectal cancer. Ann. Oncol., 9 (Suppl. 4): 36, 1998.
18. Harstrick, A., Meyer, S., Hilger, R., Muller, C., Dohman, D., and Kloppel, R. Combination therapy with infusional 5-FU and Tomudex for patients with advanced colorectal cancer. A Phase I study. Ann. Oncol., 9 (Suppl. 4): 35, 1998.
19. Aherne, G. W., Ward, E., Lawrence, N., Dobinson, D., Clarke, S. J., Musgrave, H., Sutcliffe, R., Stephens, T., and Jackman, A. L. Comparison of plasma and tissue levels of ZD 1694 (Tomudex), a highly polyglutamatable quinazoline thymidylate synthase inhibitor, in preclinical models. Br. J. Cancer, 77: 221-226, 1998.
20. Port, R. E., Edler, L., Herrmann, R., and Feldmann, U. Pharmacokinetics of 5-fluorouracil after short systemic infusion: plasma level at the end of the distribution phase as an indicator of the total area under the plasma concentration-time curve. Ther. Drug Monit., 13: 96-102, 1991.
21. Moore, M. J., Erlichman, C., Thiessen, J. J., Bunting, P. S., Hardy, R., Kerr, I., and Soldin, S. Variability in the pharmacokinetics of cyclophosphamide, methotrexate and 5-fluorouracil in women receiving adjuvant treatment for breast cancer. Cancer Chemother. Pharmacol., 33: 472-476, 1994.
22. Etienne, M. C., Lagrange, J. L., Dassonville, O., Fleming, R., Thyss, A., Renee, N., Schneider, M., Demard, F., and Milano, G. Population study of dihydropyrimidine dehydrogenase in cancer patients. J. Clin. Oncol., 12: 2248-2253, 1994.
23. Comlla, P., Palmieri, G., Lorusso, V., Catalano, G., Nicolella, D., Ianniello, G. P., Casaretti, R., Montella, M., Frasci, G., Perna, M., and Comella, G. Double biochemical modulation of 5-fluorouracil by methotrexate and levofolinic acid in the treatment of advanced digestive tract malignancies. Eur. J. Cancer, 32: 1719-1726, 1996.
24. Caponigro, F., Comella, P., Marcolin, P., Russo Spena, F., Biglietto, M., Cartenì, G., De Lucia L., Avallone, A., Gravina, A., and Comella, G. Phase II trial of cisplatin, methotrexate, levofolinic acid and 5-fluorouracil in locally advanced and metastatic squamous cell carcinoma of the head and neck. Cancer (Phila.), 85: 952-959, 1999.
25. Kelland, L. R., Kimbell, R., Hardcastle, A., Aherne, G. W., and Jackman, A. L. Relationships between resistance to cisplatin and antifolates in sensitive and resistant tumour cell lines. Eur. J. Cancer, 31: 981-986, 1995.