A randomised phase II multicentre trial of irinotecan (CPT-II) using four different schedules in patients with metastatic colorectal cancer
In: British journal of cancer, Jg. 91 (2004), Heft 8, S. 1434-1441
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Zugriff:
The purpose of this phase II trial was to compare the efficacy, safety and pharmacokinetics of four irinotecan schedules for the treatment of metastatic colorectal cancer. In total, 174 5-fluorouracil pretreated patients were randomised to: arm A (n=41), 350 mg m-2irinotecan as a 90-min i.v. infusion q3 weeks; arm B (n = 38), 125 mg m 2irinotecan as a 90-min i.v. infusion weekly x 4 weeks q6 weeks; arm C (n = 46), 250 mgm 2 irinotecan as a 90-min i.v. infusion q2 weeks; or arm D (n = 49), 10mg m day irinotecan as a 14-day continuous infusion q3 weeks. No significant differences in efficacy across the four arms were observed, although a shorter time to treatment failure was noted for arm D (1.7 months; P = 0.02). Overall response rates were in the range 5 11%. Secondary end points included median survival (6.4-9.4 months), and time to progression (2.7-3.8 months) and treatment failure (1.7 - 3.2 months). Similarly, there were no significant differences in the incidence of grade 3 4 toxicities, although the toxicity profile between arms A, B, and C and D did differ. Generally, significantly less haematologic toxicity, alopecia and cholinergic syndrome were observed in arm D; however, there was a trend for increased gastrointestinal toxicity. Innotecan is an effective and safe second-line treatment for colorectal cancer. The schedules examined yielded equivalent results, indicating that there is no advantage of the prolonged vs short infusion schedules.
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A randomised phase II multicentre trial of irinotecan (CPT-II) using four different schedules in patients with metastatic colorectal cancer
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Autor/in / Beteiligte Person: | SCHOEMAKER, N. E ; KUPPENS, I. E. L. M ; VOZNYI, E ; NORUM, J ; FENNELLY, D ; TVEIT, K. M ; GARIN, A ; GRUIA, G ; MOURIER, A ; SIBAUD, D ; LEFEBVRE, P ; BEIJNEN, J. H ; MOISEYENKO, V ; SCHELLENS, J. H. M ; TEN BOKKEL HUININK, W. W ; GLIMELIUS, B ; KJAER, M ; STARKHAMMER, H ; RICHEL, D. J ; SMAALAND, R ; BERTELSEN, K ; POULSEN, J. P |
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Zeitschrift: | British journal of cancer, Jg. 91 (2004), Heft 8, S. 1434-1441 |
Veröffentlichung: | Basingstoke: Nature Publishing Group, 2004 |
Medientyp: | academicJournal |
Umfang: | print, 1 p.1/4 |
ISSN: | 0007-0920 (print) |
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