Phase I study of 3-week schedule of irinotecan combined with cisplatin in patients with advanced solid tumors

被引:31
作者
de Jonge, MJA
Sparreboom, A
Planting, AST
van der Burg, MEL
de Boer-Dennert, MM
ter Steeg, J
Jacques, C
Verweij, J
机构
[1] Rotterdam Canc Inst, Daniel den Hoed Klin, Dept Med Oncol, NL-3075 EA Rotterdam, Netherlands
[2] Univ Rotterdam Hosp, Rotterdam, Netherlands
[3] Rhone Poulenc Rorer, Antony, France
关键词
D O I
10.1200/JCO.2000.18.1.187
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: To assess the feasibility, pharmacokinetic interaction, and possible sequence-dependent effects of the irinotecan/cisplatin combination given every 3 weeks, and to assess the influence of additional granulocyte colony-stimulating factor (G-CSF) on the hematalogic toxicity. Patients and Methods: Patients who had received no more than one prior combination chemotherapy regimen or two single-agent regimens were entered, Treatment consisted of a 90-minute irinotecan infusion followed by a 3-hour cisplatin infusion on day 1, with cycles repeated once every 3 weeks. After the maximum-tolerated dose was determined, the sequence of administration war; reversed. In a separate cohort of six patients, we assessed the effect of G-CSF on the experienced hematologic toxicity and dose-intensity. Irinotecan doses ranged from 175 to 300 mg/m(2) and cisplatin doses ranged from 60 to 80 mg/m(2). Results: Fifty-two patients entered the study; one was not eligible, and two were not assessable for response. Twenty-five patients were pretreated, and 26 were not. Fifty-one patients received a total of 223 courses. The dose-limiting toxicity was a combination of neutropenic fever, diarrhea, and fatigue at a dose level combining irinotecan 300 mg/m(2) with cisplatin 80 mg/m(2), Neutropenia was common (grades 3 to 4, 68%). Irinotecan pharmacokinetics were linear over the dose range studied. No sequence-dependent side effects were observed. Tumor responses included three complete responses and eight partial responses. Conclusion: For phase II studies, we recommend irinotecan 260 mg/m(2) combined with cisplatin 80 mg/m(2) once every 3 weeks for chemotherapy-naive patients in good physical condition, and irinotecan 200 mg/m(2) combined with cisplatin 80 mg/m(2) for other patients. (C) 2000 by American Society of Clinical Oncology.
引用
收藏
页码:187 / 194
页数:8
相关论文
共 43 条
  • [21] MALIEPAARD M, P 8 C DNA TOP 1997
  • [22] CPT-11 IN COMBINATION WITH CISPLATIN FOR ADVANCED NON-SMALL-CELL LUNG-CANCER
    MASUDA, N
    FUKUOKA, M
    TAKADA, M
    KUSUNOKI, Y
    NEGORO, S
    MATSUI, K
    KUDOH, S
    TAKIFUJI, N
    NAKAGAWA, K
    KISHIMOTO, S
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 1992, 10 (11) : 1775 - 1780
  • [23] PHASE-I STUDY OF IRINOTECAN AND CISPLATIN WITH GRANULOCYTE-COLONY-STIMULATING FACTOR SUPPORT FOR ADVANCED NON-SMALL-CELL LUNG-CANCER
    MASUDA, N
    FUKUOKA, M
    KUDOH, S
    KUSUNOKI, Y
    MATSUI, K
    NAKAGAWA, K
    HIRASHIMA, T
    TAMANOI, M
    NITTA, T
    YANA, T
    NEGORO, S
    TAKIFUJI, N
    TAKADA, M
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 1994, 12 (01) : 90 - 96
  • [24] PHASE-I AND PHARMACOLOGICAL STUDY OF IRINOTECAN IN COMBINATION WITH CISPLATIN FOR ADVANCED LUNG-CANCER
    MASUDA, N
    FUKUOKA, M
    KUDOH, S
    KUSUNOKI, Y
    MATSUI, K
    TAKIFUJI, N
    NAKAGAWA, K
    TAMANOI, M
    NITTA, T
    HIRASHIMA, T
    NEGORO, S
    TAKADA, M
    [J]. BRITISH JOURNAL OF CANCER, 1993, 68 (04) : 777 - 782
  • [25] INHIBITION OF CIS-DIAMMINEDICHLOROPLATINUM (II)-INDUCED DNA INTERSTRAND CROSS-LINK REMOVAL BY 7-ETHYL-10-HYDROXY-CAMPTOTHECIN IN HST-1 HUMAN SQUAMOUS-CARCINOMA CELLS
    MASUMOTO, N
    NAKANO, S
    ESAKI, T
    FUJISHIMA, H
    TATSUMOTO, T
    NIHO, Y
    [J]. INTERNATIONAL JOURNAL OF CANCER, 1995, 62 (01) : 70 - 75
  • [26] Mori K, 1997, EUR J CANCER, V33, P503
  • [27] A phase I study of irinotecan and infusional cisplatin for advanced non-small-cell lung cancer
    Mori, K
    Ohnishi, T
    Yokoyama, K
    Tominaga, K
    [J]. CANCER CHEMOTHERAPY AND PHARMACOLOGY, 1997, 39 (04) : 327 - 332
  • [28] MORI K, 1997, P AN M AM SOC CLIN, V16, pA476
  • [29] REED E, 1988, ATOM SPECTROSC, V9, P93
  • [30] Rivory LP, 1997, CLIN CANCER RES, V3, P1261