scholarly journals Preliminary Safety Data from Randomized Phase II Study Comparing Dose-Escalated Weekly Paclitaxel Versus Standard-Dose Weekly Paclitaxel for Patients with Previously Treated Advanced Gastric Cancer

2012 ◽  
Vol 23 ◽  
pp. xi99
Author(s):  
M. Nakamura ◽  
K. Shitara ◽  
S. Yuki ◽  
D. Takahari ◽  
C. Kondo ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Standard Dose ◽  
Safety Data ◽  
Weekly Paclitaxel ◽  
Randomized Phase Ii ◽  
Previously Treated

Randomized phase II study comparing dose-escalated weekly paclitaxel versus standard dose weekly paclitaxel for patients with previously treated advanced gastric cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4076-4076
Author(s):  
Kohei Shitara ◽  
Satoshi Yuki ◽  
Daisuke Takahari ◽  
Michio Nakamura ◽  
Chihiro Kondo ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Dose Escalation ◽  
Standard Dose ◽  
Phase Iii ◽  
Weekly Paclitaxel ◽  
Subset Analysis ◽  
Randomized Phase Ii ◽  
Previously Treated

4076 Background: Retrospective analyses of neutropenia during chemotherapy of weekly paclitaxel (wPTX) suggested better overall survival (OS) among patients with neutropenia. We conducted a randomized phase II trial comparing dose-escalated wPTX with dose adjustments determined by degree of neutropenia versus standard-dose wPTX for patients with previously treated advanced gastric cancer (AGC). Methods: Ninety-patients with AGC that progressed during one or more previous chemotherapy regimens were randomized to a standard dose of wPTX (80 mg/m2, standard dose arm) or an escalated dose of wPTX (80 mg/m2 on day 1, 100 mg/m2 on day 8, and 120 mg/m2 on day 15 unless severe toxicity nor neutropenia<1.5 x 109/L is observed, escalated dose arm) to assess superiority with a one-sided alpha of 0.3 and a power of 0.8. Results: The primary endpoint of median OS showed a trend towards longer survival in the dose-escalated arm (11.8 vs. 9.6 months; hazard ratio [HR], 0.75; 95% CI, 0.45-1.22; one-sided P=0.12). Median progression-free survival (PFS) was significantly longer in the dose-escalated arm (4.3 vs. 2.5 months, HR, 0.55; 95% CI, 0.34-0.90; P=0.017). Objective response rate was 30.3% with dose-escalation and 17.1% with standard dose (P=0.2). The disease control rate (DCR) was significantly higher with dose-escalation (78.8% vs. 48.6%, P=0.009). Subset-analysis according to stratification factors including ECOG PS, presence of measurable lesions and lines of previous chemotherapy indicated that OS benefit of the dose escalation is more prominent in PS 0-1 patients (N=81, median 13.6 vs. 9.8 months, HR 0.68, 95% CI 0.41-1.11) than PS2 patients with significant interaction (p=0.01) Conclusions: Dose escalated wPTX was associated with sufficiently longer OS in patients with pretreated AGC. In addition, significant longer PFS and higher DCR associated with dose-escalation and subset analysis according PS warrant further investigations in phase III trials, especially in patients with favorable PS patients. Clinical trial information: UMIN000004055.

scholarly journals Randomized Phase II Study of CPT-11 vs PTX; +/- S1 in Advanced Gastric Cancer Refractory to S1 or S1 + Platinum

2014 ◽  
Vol 25 ◽  
pp. ii28
Author(s):  
Goto Masahiro ◽  
Imamura Hiroshi ◽  
Kawase Tomono ◽  
Kimura Yutaka ◽  
Ueda Shugo ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Randomized Phase Ii

Phase II study of weekly paclitaxel by one-hour infusion for advanced gastric cancer

Surgery Today ◽  
2008 ◽  
Vol 38 (11) ◽  
pp. 1013-1020 ◽  
Author(s):  
Yasunori Emi ◽  
Manabu Yamamoto ◽  
Ikuo Takahashi ◽  
Hiroyuki Orita ◽  
Yoshihiro Kakeji ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Weekly Paclitaxel

Phase II study of weekly paclitaxel in patients with advanced gastric cancer in Japan

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 4226-4226
Author(s):  
H. Baba ◽  
Y. Emi ◽  
Y. Kakeji ◽  
E. Tokunaga ◽  
S. Ushiro ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Weekly Paclitaxel
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