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

Esophageal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861690
• Other study ID #: Esophageal cancer 001
• Status: Completed
• Phase: Phase 2
• First received: July 28, 2016
• Last updated: August 5, 2016
• Start date: January 2010
• Est. completion date: January 2016

Study information

• Verified date: August 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Esophageal Carcinoma
• Esophageal Neoplasms

Intervention

Drug:
• Liposomal Paclitaxel
Patients received Liposomal Paclitaxel 175mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.
• Nedaplatin
Patients received Nedaplatin80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.

Locations

Country	Name	City	State
China	Medical Oncology,Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes