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

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Esophageal Carcinoma

Treatments: Drug: Nedaplatin; Drug: Liposomal Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT02861690

Esophageal cancer 001

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Treatment group

Experimental group

Description:

patients received Liposomal Paclitaxel and Nedaplatin every 21 days until the presence of progressive disease or unacceptable toxicity

Treatment:

Drug: Liposomal Paclitaxel

Drug: Nedaplatin