Phase II protocol for the evaluation of new treatments in patients with advanced gastric carcinoma: results of ECOG 5282

1999 ◽  
Vol 16 (4) ◽  
pp. 261-266 ◽  
Author(s):  
Y Novik ◽  
LM Ryan ◽  
DG Haller ◽  
R Asbury ◽  
JP Dutcher ◽  
...  
Cancer ◽  
1999 ◽  
Vol 86 (4) ◽  
pp. 572-576 ◽  
Author(s):  
Ramesh K. Ramanathan ◽  
Stuart Lipsitz ◽  
Robert F. Asbury ◽  
Raman Qazi ◽  
Bernard R. Greenberg ◽  
...  

2007 ◽  
Vol 25 (22) ◽  
pp. 3217-3223 ◽  
Author(s):  
Arnaud D. Roth ◽  
Nicola Fazio ◽  
Roger Stupp ◽  
Stephen Falk ◽  
Jürg Bernhard ◽  
...  

PurposeThis randomized phase II trial evaluated two docetaxel-based regimens to see which would be most promising according to overall response rate (ORR) for comparison in a phase III trial with epirubicin-cisplatin-fluorouracil (ECF) as first-line advanced gastric cancer therapy.Patients and MethodsChemotherapy-naïve patients with measurable unresectable and/or metastatic gastric carcinoma, a performance status ≤ 1, and adequate hematologic, hepatic, and renal function randomly received ≤ eight 3-weekly cycles of ECF (epirubicin 50 mg/m2on day 1, cisplatin 60 mg/m2on day 1, and fluorouracil [FU] 200 mg/m2/d on days 1 to 21), TC (docetaxel initially 85 mg/m2on day 1 [later reduced to 75 mg/m2as a result of toxicity] and cisplatin 75 mg/m2on day 1), or TCF (TC plus FU 300 mg/m2/d on days 1 to 14). Study objectives included response (primary), survival, toxicity, and quality of life (QOL).ResultsORR was 25.0% (95% CI, 13% to 41%) for ECF, 18.5% (95% CI, 9% to 34%) for TC, and 36.6% (95% CI, 23% to 53%) for TCF (n = 119). Median overall survival times were 8.3, 11.0, and 10.4 months for ECF, TC, and TCF, respectively. Toxicity was acceptable, with one toxic death (TC arm). Grade 3 or 4 neutropenia occurred in more treatment cycles with docetaxel (TC, 49%; TCF, 57%; ECF, 34%). Global health status/QOL substantially improved with ECF and remained similar to baseline with both docetaxel regimens.ConclusionTime to response and ORR favor TCF over TC for further evaluation, particularly in the neoadjuvant setting. A trend towards increased myelosuppression and infectious complications with TCF versus TC or ECF was observed.


1993 ◽  
Vol 29 ◽  
pp. S101 ◽  
Author(s):  
A Sulkes ◽  
F Cavalli ◽  
A van Oosterom ◽  
S Kaye ◽  
J Wanders ◽  
...  

1986 ◽  
Vol 111 (S1) ◽  
pp. S85-S85 ◽  
Author(s):  
W. Queißer ◽  
H. Flechtner ◽  
M. E. Heim ◽  
H. Henß ◽  
H. Arnold ◽  
...  

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