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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Albumin-Bound Paclitaxel; Nedaplatin; Paclitaxel

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