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

NCT ID: NCT02861690

Last Updated: 2016-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Esophageal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

Liposomal Paclitaxel

Intervention Type: DRUG

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

Nedaplatin

Intervention Type: DRUG

Patients received Nedaplatin80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.

Interventions

Liposomal Paclitaxel

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

Intervention Type: DRUG

Nedaplatin

Patients received Nedaplatin80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ruihua Xu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rui-hua Xu

Role: STUDY_CHAIR

Sun Yat-sen UniversityCancer center

Locations

Medical Oncology,Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

Esophageal cancer 001

Identifier Type: -

Identifier Source: org_study_id