gms | German Medical Science

27. Deutscher Krebskongress

Deutsche Krebsgesellschaft e. V.

22. - 26.03.2006, Berlin

Phase I study of four different schedules of pemetrexed, gemcitabine and cisplatin in patients with locally advanced or metastatic solid tumors

Meeting Abstract

  • corresponding author presenting/speaker Corinna Lübbing - Allgem. Krankenhaus St. Georg, Hamburg, Deutschland
  • Emine Yilmaz - Allgem. Krankenhaus St. Georg, Hamburg
  • Tobias Graefe - Allgem. Krankenhaus St. Georg, Hamburg
  • Claus Bolling - Allgem. Krankenhaus St. Georg, Hamburg
  • Henrik Depenbrock - Allgem. Krankenhaus St. Georg, Hamburg
  • Ute Ohnmacht - Lilly Deutschland GmBH, Bad Homburg
  • Sigrun Müller-Hagen - Onkologische Gemeinschaftspraxis, Hamburg
  • Axel-Rainer Hanauske - Allgem. Krankenhaus St. Georg, Hamburg

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPO448

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/dkk2006/06dkk558.shtml

Veröffentlicht: 20. März 2006

© 2006 Lübbing et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Objective: Determination of the maximum tolerated dose (MTD) of four different schedules of Premetrexed (P) in combination with Gemcitabine (G) and Cisplatin (C). Secondary objectives were to determine dose limiting toxicities (DLTs), the recommended dose and schedule for subsequent studies and to collect anecdotal data of antitumor activity.

Methods: The following schedules were studied: In the q21d schedule PGC was administered on day (d) 1 and G on d8. Three q28d schedules were studied: A GP was administered d1 and GC d15, B GC was given d1 and PC d 15 and C: PGC on d1 and d15. Pemetrexed was administered intravenous (IV) over 10 minutes (min), G IV over 30 min and C IV over 120 min. We used standard pre- and postmedication.

Results: 60 patients (pts, 43 male, age range 39-77) were enrolled in this trial, one patient is still under treatment. To date a total of 22/34/102/11 courses were administered in schedule q21d/A/B/C. In the q21d schedule 4 patients of 7 in 2 dose levels (level 2 PGC 500/800/40 mg/m²) experienced DLTs, which did not qualify for MTD. Dose escalation was stopped in favour of the q28d schedules. In schedule A 12 pts were enrolled into 3 dose levels (level 3: 500/1000 /50). 4 DLTs occurred, the MTD was reached due thrombocytopenia which caused cycle delay. In schedule B 30 pts were treated in 8 dose levels (level 7: 600/1250/ 70, level 8 600/1250/60). 1 DLT was observed on dose level 7 (elevated creatinine clearance), 1 DLT on dose level 8 (fatigue an syncope) In arm C 4 pts were treated in 1 dose level (500/800/40), 4 DLTs were observed with fatigue qualifying for MTD. Tumor types were: head and neck (18), prostate (7), NSCLC (6), CUP (6), stomach (5), sarcoma (5), mesothelioma (4), esophagus (2), kidney (2), others( 5). We observed 1/2/7/0 partial responses and 7/4/11/1 stable diseases. The most commonly observed toxicity was neutropenia grade IV (in 6/6/11/2 pts).

Conclusion: The PGC combination is feasible and demonstrates clinical antitumor activity. The MTD has been reached in all schedules. In schedule B treatment continues at dose level 7. Schedule q21d, A and C were discontinued due to toxicities. Schedule B seems to be the best tolerated schedule with most pts enrolled, most courses administered and highest tolerated doses. The recommended dose for further studies has still to be confirmed.