A Randomized Study of GEMOX With or Without Cetuximab in Locally Advanced and Metastatic BTC (BTC)
|ClinicalTrials.gov Identifier: NCT01267344|
Recruitment Status : Completed
First Posted : December 28, 2010
Last Update Posted : May 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma Adenocarcinoma of Gallbladder||Drug: gemcitabine, oxaliplatin Drug: cetuximab, gemcitabine, oxaliplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Study of Gemcitabine Plus Oxaliplatin (GEMOX) With or Without Cetuximab in Locally Advanced and Metastatic Biliary Tract Cancer (BTC)|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||May 2015|
U.S. FDA Resources
Active Comparator: GEMOX
Intravenous infusion of gemcitabine 800 mg/m2 at a fixed rate of 10 mg/m2/min followed by oxaliplatin 85 mg/m2 2-hour infusion, every 2 weeks.
Drug: gemcitabine, oxaliplatin
GEMOX (intravenous infusion of gemcitabine 800 mg/m2 at a fixed rate of 10 mg/m2/min followed by oxaliplatin 85 mg/m2 2-hour infusion, every 2 weeks
Other Name: Gemmis, Eloxatin
Arm A will receive E-GEMOX with additional intravenous infusion of cetuximab (120 minutes for the 1st, 90 minutes for the 2nd and 60 minutes for all subsequent infusions) before GEMOX will be administered as above.
Drug: cetuximab, gemcitabine, oxaliplatin
E-GEMOX: intravenous infusion of cetuximab (120 minutes for the 1st, 90 minutes for the 2nd and 60 minutes for all subsequent infusions) before GEMOX will be administered as above. All of the study medication will be administrated on day 1 every 2 weeks, which is regarded as one cycle.
Other Name: Erbitux@, Eloxatin
- objective response rate [ Time Frame: baseline and every 8 weeks ]Evaluation of tumor response according to RECIST 1.1 version Evaluation will be done at baseline and every 8 weeks. Evaluation will be performed with CT or MRI.
- The toxicity profiles of the combination treatments [ Time Frame: Baseline and every 2 weeks, ]Treatment toxicity will be graded by NCI Common Toxicity Criteria Version 4.0 (CTC, v4.0) for safety evaluation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267344
|National Institute of Cancer Research, Taiwan Cooperative Oncology Group|
|Zhunan, Miaoli County, Taiwan, 350|
|Study Chair:||Li Tz Chen, PHD||National Institute of Cancer Research|
|Study Director:||Tsang Wu Liu, MD||National Institute of Cancer Research, TCOG|