Liposomal Paclitaxel Combined Nedaplatin in Treatment of Advanced or Recurrent Esophageal Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal Carcinoma

Detailed Description
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The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal Carcinoma.Patients receive Liposomal Paclitaxel 175mg/m2 and Nedaplatin 80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.

Official Title
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Phase II Study of Liposomal Paclitaxel With Nedaplatin as First-line in Advanced or Recurrent Esophageal Carcinoma

Conditions
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Esophageal Carcinoma

Intervention / Treatment
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* Drug: Liposomal Paclitaxel
* Drug: Nedaplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria: histological confirmed advanced metastatic or recurrent esophageal cancer age between 18 and 80 years ECOG performance status of 0 to 2 life expectancy ≥ 12 weeks has evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) at least one prior chemotherapy regimen adequate bone marrow function as defined by absolute neutrophil count more than or equal to 2000/mm3 platelet count more than or equal to 100,000/mm3 and hemoglobin more than or equal to 8 g/dL adequate renal function defined by creatinine less than or equal to 1.25 × upper limit of normal(ULN) and creatinine clearance more than or equal to 60mL/min, adequate liver function defined by bilirubin less than or equal to 1.0×ULN aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 2.5 ×ULN. Exclusion Criteria: other primary malignancy symptomatic central nervous system metastasis pregnancy or lactation cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure ongoing infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>patients received Liposomal Paclitaxel and Nedaplatin every 21 days until the presence of progressive disease or unacceptable toxicity | Drug: Liposomal Paclitaxel<br>* Patients received Liposomal Paclitaxel 175mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.<br>Drug: Nedaplatin<br>* Patients received Nedaplatin80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | To assess the response rate of Liposomal Paclitaxel and Nedaplatin in patients with pretreated advanced or recurrent esophageal carcinoma. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | from date of baseline measured to date of first CT evaluation，Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | Progression-free survival (PFS) is defined as the time from the date of study enrollment to the date of objectively determined PD or death from any cause, whichever comes first. For patients who are still alive at the time of analysis, and who do not have PD, PFS will be censored at the date of the last objective progression-free disease assessment. | from date of baseline to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | 
| overall survival | Overall survival is defined as the time from the date of study enrollment to the date of death from any cause. | baseline to date of death from any cause，up to 2 approximately years | 
| Number of Participants With Adverse Events (Toxicity) | Number of participants with treatment-related adverse events as assessed by CTCAE. | Up to 30 days post last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Cancer, nedaplatin, Liposomal Paclitaxel