A Study on Predictive Value of ERCC1 in Esophageal Cancer Patients Treated With Paclitaxel and Cisplatin
The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and paclitaxel in esophageal cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase Ⅱ Study on Low-expression and High-expression of ERCC1 in Recurrent or Metastastic Esophageal Cancer Patients Treated With Biweekly Paclitaxel and Cisplatin|
- Overall response rate (ORR) [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]The primary objective of this study is to determine the response rate of paclitaxel plus cisplatin as first-line therapy in patients with locally advanced, recurrent or metastatic esophageal carcinoma
- Time to event efficay [ Time Frame: 5 year ] [ Designated as safety issue: No ]
The following time to event efficacy measures:
- Duration of overall response for responding patients
- Time to documented progressive disease
- Overall survival
- The quantitative and qualitative toxicity of paclitaxel plus cisplatin.
- Determinant of efficacy of the treatment with paclitaxel and cisplatin in the patient population by means of the analysis of ERCC1
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
|Experimental: single-arm Paclitaxel-Cisplatin||
Drug: paclitaxel and cisplatin
Paclitaxel 150 mg/m2 will be administered as an intravenous (IV) infusion over 3 hour on Days 1; Cisplatin 50 mg/m2 will be administered as an intravenous (IV) infusion on Days 2, and to take enough hydration in the day and the next day.
14 days as a cycle, up to 8 cycles.
Other Name: Paclitaxel,Beijing Union Pharmaceutical Factory
Open label single arm phase II study of cisplatin and paclitaxel in patients with recurrent or metastatic esophageal cancer. 92 Patients will be enrolled in this local trial. The primary objective of this study is to determine the response rate of the treatment.Schedule for this study is as follows: paclitaxel 150 mg/m2 will be administered as an intravenous infusion over 3 hour on Days 1, followed by cisplatin 50 mg/m2 on Days 2. This study will also include the investigation of ERCC1 expression in order to assess determinants of efficacy of the treatment with cisplatin and paclitaxel in the study population.
|Contact: Yi Zhou, M.Dfirstname.lastname@example.org|
|Contact: Xiao Lv, M.Demail@example.com|
|Cancer Institute and Hospital, Chinese Academy of Medical Sciences||Recruiting|
|Beijing, China, 100021|
|Contact: Yi Zhou, M.D 8610-87788800 firstname.lastname@example.org|
|Contact: Xiao Lv, M.D 8610-87788800 email@example.com|
|Principal Investigator: Jing Huang, M.D.,Ph.D|
|Principal Investigator:||Jing Huang, M.D.,Ph.D||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|