A Study on Predictive Value of ERCC1 in Esophageal Cancer Patients Treated With Paclitaxel and Cisplatin

Phase 2

• Conditions: Esophageal Cancer
• Interventions: Drug: paclitaxel and cisplatin

• Registration Number: NCT01444547
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and paclitaxel in esophageal cancer

Detailed Description

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-09-30
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-02
• Last Update Posted: 2014-05-06
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Histologically proven diagnosis of the squamous cell carcinoma or adenocarcinoma of esophagus
• locally advanced, recurrent or metastatic disease
• Performance Status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status Scale
• Previous adjuvant or pre-operative chemotherapy without containing paclitaxel or platinum at least 12 months before enrollment
• Adequate organ function including the following:

Bone marrow: absolute neutrophil count (ANC) >or equal to 1.5 * 109/L, platelets >or equal to 100 *109/L, hemoglobin > or equal to 10 g/dL.

Hepatic: bilirubin < or equal to 1.5 x ULN; alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) < or equal to 3 x ULN (alkaline phosphatase, AST, ALT minor or equal to 5 x ULN is acceptable if liver has tumor involvement), serum albumin > or equal to3g/dL.

Renal: Calculated creatinine clearance major or equal to 60 ml/min (using the standard Cockcroft-Gault formula).

Exclusion Criteria

• No Prior palliative chemotherapy for advanced disease
• Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed at least 30 days before study enrollment
• Known or suspected brain metastasis
• Second primary malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single-arm Paclitaxel-Cisplatin	paclitaxel and cisplatin	-

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	5 year	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

Secondary Outcome Measures

Name	Time	Method
Time to event efficay	5 year	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

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China