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

Sun Yat-sen University72 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Carcinoma

Interventions

Liposomal PaclitaxelDRUG

Patients received Liposomal Paclitaxel 175mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.

NedaplatinDRUG

Patients received Nedaplatin80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: Inclusion Criteria: 1. histological confirmed advanced metastatic or recurrent esophageal cancer 2. age between 18 and 80 years 3. ECOG performance status of 0 to 2 4. life expectancy ≥ 12 weeks 5. has evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 6. at least one prior chemotherapy regimen 7. adequate bone marrow function as defined by absolute neutrophil count more than or equal to 2000/mm3 8. platelet count more than or equal to 100,000/mm3 and hemoglobin more than or equal to 8 g/dL 9. 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, 10. 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: 1. other primary malignancy 2. symptomatic central nervous system metastasis 3. pregnancy or lactation 4. cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure 5. ongoing infection

Locations (1)

Medical Oncology,Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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.

Time frame: from date of baseline measured to date of first CT evaluation，Up to 3 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 30 days post last dose

Data from ClinicalTrials.gov

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