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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: paclitaxel and cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-arm Paclitaxel-Cisplatin<br> | Drug: paclitaxel and cisplatin<br>* 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.<br>* Other names: Paclitaxel,Beijing Union Pharmaceutical Factory;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | 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 | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to event efficay | 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 | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal cancer, paclitaxel, cisplatin