TY - JOUR
T1 - Phase II trial of T138067, a novel microtubule inhibitor, in patients with metastatic, refractory colorectal carcinoma
AU - Berlin, Jordan D.
AU - Venook, Alan
AU - Bergsland, Emily
AU - Rothenberg, Mace
AU - Lockhart, A. Craig
AU - Rosen, Lee
PY - 2008/1
Y1 - 2008/1
N2 - Background: This study was conducted before the approval of oxaliplatin, cetuximab, and bevacizumab and was designed to evaluate a novel microtubule targeting agent, T138067, in patients with metastatic colorectal cancer (CRC) previously treated with irinotecan and 5-fluorouracil. Patients and Methods: Patients from 3 institutions were enrolled over 4 months and treated with T138067 on days 1, 8, and 15 of a 21-day cycle. Disease evaluation was performed after 9 weeks. Results: Treatment was tolerable with moderate hematologic and gastrointestinal toxicity. Neurotoxicity, an expected side effect, was minimal. Among 23 evaluable patients, there were no responses. Median time to tumor progression was 1.4 months and median survival was 9.3 months. Conclusion: T138067 at this dose and schedule was well tolerated by patients with CRC. However, there was no evidence of clinical activity for T138067 in 5-fluorouracil/irinotecan-refractory CRC. The long median survival likely reflects availability of other agents and/or patient selection.
AB - Background: This study was conducted before the approval of oxaliplatin, cetuximab, and bevacizumab and was designed to evaluate a novel microtubule targeting agent, T138067, in patients with metastatic colorectal cancer (CRC) previously treated with irinotecan and 5-fluorouracil. Patients and Methods: Patients from 3 institutions were enrolled over 4 months and treated with T138067 on days 1, 8, and 15 of a 21-day cycle. Disease evaluation was performed after 9 weeks. Results: Treatment was tolerable with moderate hematologic and gastrointestinal toxicity. Neurotoxicity, an expected side effect, was minimal. Among 23 evaluable patients, there were no responses. Median time to tumor progression was 1.4 months and median survival was 9.3 months. Conclusion: T138067 at this dose and schedule was well tolerated by patients with CRC. However, there was no evidence of clinical activity for T138067 in 5-fluorouracil/irinotecan-refractory CRC. The long median survival likely reflects availability of other agents and/or patient selection.
KW - Chemotherapy
KW - Hematologic toxicity
KW - Neurologic toxicity
KW - Targeted therapy
UR - http://www.scopus.com/inward/record.url?scp=39149136517&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=39149136517&partnerID=8YFLogxK
U2 - 10.3816/CCC.2008.n.006
DO - 10.3816/CCC.2008.n.006
M3 - Article
C2 - 18279576
AN - SCOPUS:39149136517
VL - 7
SP - 44
EP - 47
JO - Clinical Colorectal Cancer
JF - Clinical Colorectal Cancer
SN - 1533-0028
IS - 1
ER -
