Phase I clinical and pharmacokinetic study of E7070, a novel sulfonamide given as a 5-day continuous infusion repeated every 3 weeks in patients with solid tumours. A study by the EORTC Early Clinical Study Group (ECSG)

European Journal of Cancer

Volumn 39, Issue 8, 2003, Pages 1097-1104

  Terret, C ^a   Zanetta, S ^b   Roche H ^a   Schellens, J H M ^c   Faber, M N ^d   Wanders, J ^d   Ravic, M ^e   Droz, J P ^b  

^a INSTITUT CLAUDIUS REGAUD   (France)

^b CENTRE LÉON BÉRARD   (France)

^c NETHERLANDS CANCER INSTITUTE   (Netherlands)

^d NDDO Oncology   (Netherlands)

^e EISAI CO LTD   (Japan)

Author keywords

E7070; Pharmacokinetics; Phase I trial; Sulfonamide

Indexed keywords

ALKALINE PHOSPHATASE; AMINOTRANSFERASE; ANTINEOPLASTIC AGENT; BILIRUBIN; INDISULAM; N (3 CHLORO 7 INDOYL) 1,4 BENZENEDISULFONAMIDE; SULFONAMIDE; UNCLASSIFIED DRUG;

ADENOCARCINOMA; ADRENAL TUMOR; ADULT; ALKALINE PHOSPHATASE BLOOD LEVEL; ALOPECIA; AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; BILIRUBIN BLOOD LEVEL; BONE MARROW SUPPRESSION; BREAST TUMOR; CLINICAL ARTICLE; CLINICAL TRIAL; COLITIS; COLORECTAL TUMOR; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DOSE RESPONSE; DRUG CLEARANCE; DRUG HALF LIFE; DRUG INTERMITTENT THERAPY; DRUG MEGADOSE; DRUG TOLERABILITY; ENDOMETRIUM TUMOR; FEMALE; HUMAN; HUMAN TISSUE; HYPOGLYCEMIA; HYPOKALEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; KIDNEY DISTAL TUBULE; KIDNEY TUMOR; LEUKOPENIA; LIVER TOXICITY; LIVER TUMOR; LUNG TUMOR; MALAISE; MALE; MAXIMUM TOLERATED DOSE; MUCOSA INFLAMMATION; NAUSEA; NEUTROPENIA; NONLINEAR SYSTEM; OSTEOSARCOMA; OVARY TUMOR; PELVIS TUMOR; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RISK FACTOR; SARCOMA; SIDE EFFECT; SOLID TUMOR; STOMACH TUMOR; STOMATITIS; THROMBOCYTOPENIA; TUBULAR DYSFUNCTION; UTERINE CERVIX TUMOR; UTERUS SARCOMA; VOMITING;

EID: 0038402755     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0959-8049(03)00128-X     Document Type: Article

References (10)

1. Owa T., Yoshino H., Okauchhi T.et al. Discovery of novel antitumor sulfonamides targeting G1 phase of the cell cycle. J. Med. Chem. 42:1999;3789-3799.
2. Ozawa Y., Sugi N.H., Nagasu T.et al. E7070, a novel sulphonamide agent with potent antitumour activity in vitro and in vivo. Eur. J. Cancer. 37:2001;2275-2282.
3. Fukuoka K., Usuda J., Iwamoto Y.et al. Mechanisms of action of the novel sulfonamide anticancer agent E7070 on cell cycle progression in human non-small cell lung cancer cells. Invest. New Drugs. 19:2001;219-227.
4. Rigas J.R., Tong W.P., Kris M.G., Orazem J.P., Young C.W., Warrell R.P. Jr. Phase I clinical and pharmacological study of chloroquinoxaline sulfonamide. Cancer Res. 52:1992;6619-6623.
5. Division of Cancer Treatment National Cancer Institute National Cancer Institute guidelines for reporting of adverse drug reactions. 1998;NCI, Bethesda.
6. World Health Organization WHO Handbook for Reporting Results of Cancer Treatment. Offset Publication 48. 1979;WHO, Geneva, Switzerland.
7. Raymond E., ten Bokkel Huinink W.W., Taieb J.et al. Phase I and pharmacokinetic study of E7070, a novel chloroindolyl sulphonamide cell-cycle inhibitor, administered as a one-hour infusion every three weeks in patients with advanced cancer. J. Clin. Oncol. 20:2002;3508-3521.
8. Punt C.J., Fumoleau P., van de Walle B., Faber M.N., Ravic M., Campone M. Phase I and pharmacokinetic study of E7070, a novel sulfonamide, given at a daily times five schedule in patients with solid tumors. A study by the EORTC-Early Clinical Studies Group (ECSG). Ann Oncol. 12:2001;1289-1293.
9. Dittrich C., Dumez H., Calvert H.et al. Phase I and pharmacokinetics study of E7070 in patients with solid tumors as single IV infusion, weekly × 4, Q six weeks. Proc. Am. Assoc. Can. Res. 41:2000;609. (abstr).
10. Van Kesteren Ch., Mathôt R.A.A., Raymond E.et al. Population pharmacokinetics of the novel anticancer agent E7070 during four phase I studies: model building and validation. J. Clin. Oncol. 20:2002;4065-4073.