TY - JOUR
T1 - Phase I study of spiroplatin
AU - Tanis, Bea C.
AU - Vermorken, Jan B.
AU - Ten Bokkel Huinink, Wim W.
AU - Klein, Ina
AU - Gall, Helen
AU - Van Oosterom, Allan T.
AU - Simonetti, Godelaine
AU - Gordon McVie, J.
AU - Van Der Vijgh, Wim J F
AU - Pinedo, Herbert M.
PY - 1991
Y1 - 1991
N2 - Spiroplatin was investigated in a multicentre phase I study. 67 patients with advanced solid tumours received 151 cycles either by short-term or prolonged infusion, repeated every 3 weeks, at 2.5-40 mg/m2. Myelosuppression and renal toxicity were dose-limiting. Proteinuria, which was dose- and schedule-dependent, indicated glomerular and tubular damage. The maximum tolerated doses (MTD) for poor-risk and good-risk patients were 35 and 40 mg/m2, respectively. The area under the curve (AUC) at the MTD did not correspond with the AUC at the LD10 in mice with ratios of 0.3 for free platinum and 2.6 for total platinum; these were not suitable for predicting the MTD. 1 complete response was observed in a patient with breast cancer and lung metastases and 1 partial response in a patient with adenocarcinoma of the lung. The recommended dose for phase II studies was 30 mg/m2 by 4 h infusion every 3 weeks.
AB - Spiroplatin was investigated in a multicentre phase I study. 67 patients with advanced solid tumours received 151 cycles either by short-term or prolonged infusion, repeated every 3 weeks, at 2.5-40 mg/m2. Myelosuppression and renal toxicity were dose-limiting. Proteinuria, which was dose- and schedule-dependent, indicated glomerular and tubular damage. The maximum tolerated doses (MTD) for poor-risk and good-risk patients were 35 and 40 mg/m2, respectively. The area under the curve (AUC) at the MTD did not correspond with the AUC at the LD10 in mice with ratios of 0.3 for free platinum and 2.6 for total platinum; these were not suitable for predicting the MTD. 1 complete response was observed in a patient with breast cancer and lung metastases and 1 partial response in a patient with adenocarcinoma of the lung. The recommended dose for phase II studies was 30 mg/m2 by 4 h infusion every 3 weeks.
UR - http://www.scopus.com/inward/record.url?scp=0025872859&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0025872859&partnerID=8YFLogxK
U2 - 10.1016/0277-5379(91)90513-D
DO - 10.1016/0277-5379(91)90513-D
M3 - Article
C2 - 1827311
AN - SCOPUS:0025872859
SN - 0277-5379
VL - 27
SP - 268
EP - 273
JO - European Journal of Cancer and Clinical Oncology
JF - European Journal of Cancer and Clinical Oncology
IS - 3
ER -