Clinical trial NCT02861690: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Carcinoma
Keywords: Esophageal Cancer
nedaplatin
Liposomal Paclitaxel
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Response rate
timeFrame: from date of baseline measured to date of first CT evaluation，Up to 3 months
Secondary outcomes:
measure: progression-free survival
timeFrame: 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
measure: overall survival
timeFrame: baseline to date of death from any cause，up to 2 approximately years
measure: Number of Participants With Adverse Events (Toxicity)
timeFrame: Up to 30 days post last dose
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Medical Oncology,Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen UniversityCancer center
name: Rui-hua Xu
role: STUDY_CHAIR
References: