Oxaliplatin, Capecitabine and Endostar as First Line Treatment for Patients With Advanced Colorectal Cancer (OXCE)
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|ClinicalTrials.gov Identifier: NCT00853684|
Recruitment Status : Unknown
Verified September 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting
First Posted : March 2, 2009
Last Update Posted : September 18, 2009
|Condition or disease||Intervention/treatment||Phase|
|Advanced Colorectal Cancer||Drug: OXCE Drug: Endostar||Phase 2|
Among the different combination regimens of new drugs in CRC treatment, the combination of capecitabine and oxaliplatin seems especially attractive. Both drugs have a different and relatively mild toxicity profile. In phase II studies that used the recommended dose of XELOX (capecitabine 1000 mg/m2 twice daily on days 1-14 with intravenous oxaliplatin 130 mg/m2 on day 1 every 3 weeks), RRs were between 42% and 55%, with PFS times of 6.0 to 7.7 months, which showed that the XELOX combination was effective in the first-line treatment of patients with metastatic CRC. (Cassidy et al, 2004; Scheithauer et al, 2003)
Colorectal carcinomas (CRC) are characterised by enhanced VEGF expression and the corresponding high microvascular densities, indicating increased angiogenic activity and leading to worse patient survival.(Zheng et al, 2003; Des Guetz et al, 2006) Recently, the final results of XELOX-1/NO16966, a study of first line therapy, confirmed that bevacizumab+chemotherapy (XELOX or FOLFOX) was superior to chemotherapy alone in terms of PFS (HR 0.83; p=0.0023) although the OS data did not reach statistical significance (HR 0.89; p=0.0769). (Saltz et al, 2008)
The bevacizumab data provide a treatment option for patients with metastatic CRC based on VEGF inhibition. It is hypothesized that other anti-angiogenic agents such as endostar, may augment the effect of chemotherapy regimens in CRC. Endostar, a recombinant human endostatin which expressed and purified in E. coli, was approved by the SFDA for the treatment of non-small-cell lung cancer in 2005. Ling et al. found that endostar suppressed the VEGF-stimulated proliferation, migration, and tube formation of human umbilical vein endothelial cells (HUVECs) in vitro, and the antiangiogenic effects of endostar were correlated with the VEGF-triggered signaling. (Ling et al, 2007) A Chinese phase III clinical trial in advanced non-small-cell lung cancer, endostar--a new angiogenesis inhibitor prolonged the overall survival, time to progression and improved response rate. (Wang et al, 2005) Based on these results, we design this phase II clinical trial of oxaliplatin, capecitabine and endostar as first line treatment, to evaluate whether endostar can bring survival benefits to patients with advanced colorectal cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Oxaliplatin, Capecitabine and Endostar as First Line Treatment for Patients With Advanced Colorectal Cancer|
|Study Start Date :||February 2009|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||March 2011|
|Experimental: oxaliplatin, capecitabine plus endostar||
Oxaliplatin 130 mg/m2 iv drip D1, Capecitabine 1000 mg/m2 bid d1-14. Every three weeks.
Other Name: Capecitabine(Xeloda®)
Endostar 7.5 mg/m2 iv drip D1-14. Every 3 weeks.
Other Name: Endostar (a recombinant human endostatin)
- Time to progression [ Time Frame: 6 months ]
- Overall survival [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853684
|Contact: Weiguo Cao, MD||+86 21 6415 email@example.com|
|Department of Oncology, Ruijin Hospital, Medical School of Shanghai Jiaotong University||Recruiting|
|Shanghai, Shanghai, China, 200035|
|Contact: Daoyuan Wang, MD +86-13601628114 firstname.lastname@example.org|
|Principal Investigator: Weiguo Cao, MD|
|Study Chair:||Weiguo Cao, MD||Department of Oncology, Ruijin Hospital, Medical School of Shanghai Jiaotong University|