scholarly journals Randomized Phase II trial of paclitaxel plus valproic acid vs paclitaxel alone as second-line therapy for patients with advanced gastric cancer

2015 ◽  
pp. 939 ◽  
Author(s):  
Sachio Fushida ◽  
Masahide Kaji ◽  
Katsunobu Oyama ◽  
Yasuo Hirono ◽  
Hideaki Nazuka ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Valproic Acid ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Randomized Phase Ii

scholarly journals Randomized phase II trial of nimotuzumab plus irinotecan versus irinotecan alone as second-line therapy for patients with advanced gastric cancer

2014 ◽  
Vol 18 (4) ◽  
pp. 824-832 ◽  
Author(s):  
Taroh Satoh ◽  
Kyung Hee Lee ◽  
Sun Young Rha ◽  
Yasutsuna Sasaki ◽  
Se Hoon Park ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Randomized Phase Ii

Mitomycin C plus S-1 as second-line therapy in patients with advanced gastric cancer: a noncomparative phase II study

2008 ◽  
Vol 19 (3) ◽  
pp. 303-307 ◽  
Author(s):  
Se Hoon Park ◽  
Young Saing Kim ◽  
Junshik Hong ◽  
Jinny Park ◽  
Eunmi Nam ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Mitomycin C ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy

E7208: A randomized phase II trial of irinotecan and cetuximab (IC) versus IC plus ramucirumab (ICR) in second line therapy of KRAS wild type colorectal cancer (CRC).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. TPS793-TPS793 ◽  
Author(s):  
Howard S. Hochster ◽  
Paul J. Catalano ◽  
Edith P. Mitchell ◽  
Deirdre Jill Cohen ◽  
Peter J. O'Dwyer ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Bowel Perforation ◽  
Second Line ◽  
Wild Type ◽  
First Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Randomized Phase Ii ◽  
Grade 3

TPS793 Background: Anti-angiogenic therapy for CRC has been accepted as standard therapy with approval of bevacizumab (bev) in both first-line and second-line settings. At the time this study was started, the benefit of continuing an anti-angiogenic in second line therapy was unproven. Ramucirumab (RAM, IMC 1121b) is a humanized antibody directed against the VEGF-R2 receptor, which may prove to have different activity compared to anti-VEGF antibody (bev). Additionally, while combining the anti-EGFR antibody, cetuximab (CMAB), with bev in first-line unselected patients was not effective, it is unknown whether the same may be true with RAM plus CMAB in a second-line setting for KRAS-selected patients. Methods: The study was designed as a randomized phase II trial with 147 patients assigned to IC = irinotecan (I) 180 mg/m2 IV plus CMAB 500 mg/m2 IV q2w versus ICR = IC plus RAM 8 mg/kg IV q2w. Eligibility included prior treatment on one prior oxaliplatin and bev-containing regimen and progression within 42 days of last bev, PS 0-1, KRAS codon 12,13 wild-type and standard other chemo and bev criteria. Doses were modified for neutropenia, diarrhea, mucositis, rash and grade 3 other toxicities. The study was activated 10/8/10. The first 35 patients were enrolled and accrual was held 6/24/12 for toxicity analysis per protocol. More grade 3 events of mucositis, diarrhea, neutropenia and perforation events (including peri-rectal abscesses) were seen in the ICR arm. The study has been modified reflect the actual doses received, and now uses modified ICR (mICR) = I 150 mg/m2, CMAB 400 mg/m2 and RAM 6 mg/kg IV q2w. The study was re-activataed in May 2014. An additional 100 pts will be accrued to the revised study, giving 85% power to detect improved median PFS from 4.5 to 7.65 months. New eligibility criteria include any progression from first-line chemo (on or off), normal albumin, no bowel perforation or obstruction in last 6 months. This study is now open to accrual in ECOG-ACRIN and in SWOG with endorsement, and via CTSU. Clinical trial information: NCT01079780.

E7208: A randomized phase II trial of irinotecan and cetuximab (IC) versus IC plus ramucirumab (ICR) in second-line therapy of KRAS wild-type colorectal cancer (CRC).

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. TPS3665-TPS3665 ◽  
Author(s):  
Howard S. Hochster ◽  
Paul J. Catalano ◽  
Edith P. Mitchell ◽  
Deirdre Jill Cohen ◽  
Peter J. O'Dwyer ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Second Line ◽  
Wild Type ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Randomized Phase Ii
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