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

Phase 2

Completed

• Conditions: Esophageal Carcinoma
• Interventions: Drug: Liposomal Paclitaxel; Drug: Nedaplatin

• Registration Number: NCT02861690
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2015-09
• Study Completion: 2016-01
• Study First Submitted: 2016-07-28
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-05
• Last Update Submitted: 2016-08-05
• Study First Posted: 2016-08-10
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Liposomal Paclitaxel	patients received Liposomal Paclitaxel and Nedaplatin every 21 days until the presence of progressive disease or unacceptable toxicity
Treatment group	Nedaplatin	patients received Liposomal Paclitaxel and Nedaplatin every 21 days until the presence of progressive disease or unacceptable toxicity

Primary Outcome Measures

Name	Time	Method
Response rate	from date of baseline measured to date of first CT evaluation，Up to 3 months	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

Name	Time	Method
overall survival	baseline to date of death from any cause，up to 2 approximately years	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)	Up to 30 days post last dose	Number of participants with treatment-related adverse events as assessed by CTCAE.
progression-free survival	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	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.

Trial Locations

Locations (1)

Medical Oncology,Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China