Phase II Trial of Chemotherapy plus Bevacizumab as Second-Line Therapy for Patients with Metastatic Colorectal Cancer That Progressed on Bevacizumab with Chemotherapy: The Gunma Clinical Oncology Group (GCOG) trial 001 SILK Study

Oncology ◽  
2012 ◽  
Vol 83 (3) ◽  
pp. 151-157 ◽  
Author(s):  
Soichi Tsutsumi ◽  
Keiichiro Ishibashi ◽  
Nobuyuki Uchida ◽  
Hitoshi Ojima ◽  
Yasuo Hosouchi ◽  
...  

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3591-3591 ◽  
Author(s):  
M. R. Moore ◽  
C. Jones ◽  
G. Harker ◽  
F. Lee ◽  
B. Ardalan ◽  
...  

3591 Background: DJ-927, a novel oral tubulin depolymerization inhibitor, causes apoptosis and DNA cell division arrest. It is not a substrate for the MDR and has excellent activity in preclinical colorectal cancer models. Methods: We are conducting a two-stage, multi-center, phase II trial to assess the efficacy of DJ-927 administered initially as second-line therapy following failure of irinotecan or oxaliplatin based therapy (n= 39). DJ-927 is given as a single oral dose on day 1 of a 21-day cycle at a dose range of 27 - 35 mg/m2. Results: Thirty-nine patients were enrolled, including 14 with prior irinotecan based therapy and 25 who had received prior oxaliplatin therapy. The median age was 56 years (range: 30–87) and the median ECOG PS at baseline was 1 (range: 0–2). A total of 155 courses (range: 1–24) have been administered with a median of 2 courses. Nine patients required dose reduction due to toxicity. Thirty-seven patients were evaluable for efficacy. There were 2 CRs and 2 PRs (10.3%) reported that were confirmed as per RECIST criteria. Fourteen patients (35.9%) had SD, including 6 patients (15.4%) with SD >12 weeks. The most common Grade 3 or 4 AEs were neutropenia (48.7%), fatigue (10.3%), neuropathy (7.8%), and nausea (5.0%).Six patients experienced febrile neutropenia, all requiring hospitalization but tolerated treatment with subsequent dose reduction. There were 13 episodes (33.3%) of peripheral neuropathy reported; however, only 3 (7.8%) were grade 3 or 4. Six patients withdrew due to adverse events. Conclusions: The results of this study indicate activity of DJ-927 as second line therapy in patients with metastatic colorectal cancer. Severe toxicity was generally limited to reversible neutropenia and peripheral neuropathy. This novel oral agent is well tolerated and warrants further evaluation in combination with other active agents. [Table: see text]



2006 ◽  
Vol 24 (2) ◽  
pp. 154-159 ◽  
Author(s):  
Mohamed Hebbar ◽  
Christophe Tournigand ◽  
Gérard Lledo ◽  
May Mabro ◽  
Thierry André ◽  
...  


2005 ◽  
Vol 23 (16_suppl) ◽  
pp. 3583-3583 ◽  
Author(s):  
A. L. A. Fields ◽  
D. A. Rinaldi ◽  
C. A. Henderson ◽  
C. J. Germond ◽  
L. Chu ◽  
...  






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 ◽  
...  


2006 ◽  
Vol 38 (4) ◽  
pp. 201
Author(s):  
Duk-Joo Lee ◽  
Ho-Suk Oh ◽  
Jung-Hye Choi ◽  
Young-Yeul Lee ◽  
In-Soon Kim ◽  
...  


Sign in / Sign up

Export Citation Format

Share Document