A Four-Arm, Randomized, Multicenter Phase II Trial of Oxaliplatin Combined with Varying Schedules of 5-Fluorouracil as First-line Therapy in Previously Untreated Advanced Colorectal Cancer

2008 ◽  
Vol 7 (2) ◽  
pp. 134-139 ◽  
Author(s):  
Ramesh K. Ramanathan ◽  
Georg A. Bjarnason ◽  
Stephen Alan Bernard ◽  
Philip Desimone ◽  
Theodore Braich ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase Ii ◽  
Advanced Colorectal Cancer ◽  
Phase Ii Trial ◽  
First Line ◽  
First Line Therapy ◽  
Multicenter Phase ◽  
Line Therapy

A Phase II Trial of Irinotecan, 5-Fluorouracil and Leucovorin Combined with Celecoxib and Glutamine as First-Line Therapy for Advanced Colorectal Cancer

Oncology ◽  
2005 ◽  
Vol 69 (1) ◽  
pp. 63-70 ◽  
Author(s):  
Chong-Xian Pan ◽  
Patrick Loehrer ◽  
David Seitz ◽  
Paul Helft ◽  
Beth Juliar ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase Ii ◽  
Advanced Colorectal Cancer ◽  
Phase Ii Trial ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

Novel cancer vaccines in combination with oxaliplatin-based chemotherapy as first-line therapy in advanced colorectal cancer: A randomized phase II study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3006-3006
Author(s):  
Hiroaki Tanaka ◽  
Shoichi Hazama ◽  
Ko Tahara ◽  
Ryoichi Shimizu ◽  
Fumiaki Sugiura ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase Ii ◽  
Median Duration ◽  
Advanced Colorectal Cancer ◽  
Negative Group ◽  
First Line ◽  
Cancer Vaccination ◽  
First Line Therapy ◽  
Line Therapy ◽  
Hla Genotype

3006 Background: A phase I cancer vaccination trial using five novel HLA-A24-binding peptides derived from not only three oncoantigens, RNF43 (ring finger protein 43), TOMM34 (34 kDa translocase of the outer mitochondrial membrane), and KOC1 (IMP-3; IGF-II mRNA binding protein 3) but also antiangiogenic cancer vaccine targeting VEGFR1 (vascular endothelial growth factor receptor 1) and VEGFR2 had revealed safety and immunogenicity in advanced colorectal cancer (CRC) as presented at 2011 ASCO Oral Abstract Session (No. 2510). We further performed a phase II trial to evaluate the benefit of the cancer vaccination in combination with oxaliplatin-based chemotherapy as first-line therapy. Methods: Ninety-six chemotherapy naïve CRC pts were enrolled to evaluate primarily response rates (RR), and secondarily OS and PFS. Each of the five peptides (3 mg each) was mixed with 1.5 ml of IFA and subcutaneously administered weekly for 12 weeks and after then biweekly. Chemotherapy was performed simultaneously as mFOLFOX6 or XELOX with/without bevacizumab. All enrolled pts had received the therapy without knowing HLA-A status double-blindly, and the HLA genotype were key-opened at analysis point and then, the endpoints are evaluated between HLA-A*2402 positive and HLA-A*2402 negative group. Results: Between February 2009 and November 2012, a total of 96 pts were enrolled in this study. The cutoff date for the main analysis was January 31, 2013 (median duration of follow-up of 26.5months). mFOLFOX6 and XELOX were administered to 93 and 3 pts, respectively. Bevacizumab was used for 5 pts. RR, the primary study end point, was 61.5% (CR 1, PR 58, SD 33, PD 4). It seemed superior as compared to other reports. The median duration to reach the best responses (14 weeks; range 8-69) was surprisingly long and indicated the delayed effect of vaccination. PFS and OS were 8.2 m and 20.7 m, respectively. The HLA genotype will be key-opened at March 2013 and the endpoints will be presented between HLA-A*2402 positive and negative group at the meeting. Conclusions: The phase II cancer vaccine therapy demonstrated the promising response, and warrants further clinical studies. Clinical trial information: UMIN000001791.

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