Back to resultsLiposomal Paclitaxel Combined Nedaplatin in Treatment of Advanced or Recurrent Esophageal Carcinoma
Primary Purpose
Esophageal Carcinoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Liposomal Paclitaxel
Nedaplatin
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Carcinoma focused on measuring Esophageal Cancer, nedaplatin, Liposomal Paclitaxel
Eligibility Criteria
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
Sites / Locations
- Medical Oncology,Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
patients received Liposomal Paclitaxel and Nedaplatin every 21 days until the presence of progressive disease or unacceptable toxicity
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
overall survival
Overall survival is defined as the time from the date of study enrollment to the date of death from any cause.
Number of Participants With Adverse Events (Toxicity)
Number of participants with treatment-related adverse events as assessed by CTCAE.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02861690
Brief Title
Liposomal Paclitaxel Combined Nedaplatin in Treatment of Advanced or Recurrent Esophageal Carcinoma
Official Title
Phase II Study of Liposomal Paclitaxel With Nedaplatin as First-line in Advanced or Recurrent Esophageal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Carcinoma
Keywords
Esophageal Cancer, nedaplatin, Liposomal Paclitaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
patients received Liposomal Paclitaxel and Nedaplatin every 21 days until the presence of progressive disease or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
Liposomal Paclitaxel
Intervention Description
Patients received Liposomal Paclitaxel 175mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Nedaplatin
Intervention Description
Patients received Nedaplatin80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.
Primary Outcome Measure Information:
Title
Response rate
Description
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 Outcome Measure Information:
Title
progression-free survival
Description
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
Title
overall survival
Description
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
Title
Number of Participants With Adverse Events (Toxicity)
Description
Number of participants with treatment-related adverse events as assessed by CTCAE.
Time Frame
Up to 30 days post last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui-hua Xu
Organizational Affiliation
Sun Yat-sen UniversityCancer center
Official's Role
Study Chair
Facility Information:
Facility Name
Medical Oncology,Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Liposomal Paclitaxel Combined Nedaplatin in Treatment of Advanced or Recurrent Esophageal Carcinoma
We'll reach out to this number within 24 hrs