Paclitaxel Liposome and Cisplatin as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Paclitaxel Liposome and Cisplatin as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer: an Open-label, Randomised Phase 3 Trial.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01998347
• Other study ID #: CSMECS 01
• Secondary ID: LYC01
• Status: Withdrawn
• Phase: Phase 3
• First received: November 17, 2013
• Last updated: November 18, 2015
• Start date: November 2013

Study information

• Verified date: November 2015
• Source: Shantou University Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

There are no standard chemotherapy regimens for metastatic esophageal cancer. Cisplatin plus 5-fluorouracil is widely used as first-line treatment with a response rate ranged from 30% to 40%. Combination of paclitaxel and cisplatin has been investigated in small size clinical trial, producing promising outcome.Liposome capsuled paclitaxel has been proved to be as effective as paclitaxel.The usefulness of the the regimen of paclitaxel liposome with cisplatin is evaluated by median survival time, progression free survival,and response rate.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed metastatic esophageal tumors with no previous treatment for advanced disease or recurrent disease after previous treatment for at least one year.

• At least one measurable lesion according to the RECIST1.1 (Response Evaluation Criteria in Solid Tumors RECIST Version 1.1) criteria. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques.

• Patients aged between 18 and 70 years, inclusive, at the time of acquisition of informed consent

• Patients with performance status(ECOG) 0 to 1.

• Abnormal hematologic values (WBC = 3.0 x 109/L, Hemoglobin = 10.0g/dl, platelet count = 100 x 109/L)

• Creatinine clearance = 60 ml/min, Serum creatinine = 1.5mg/dl

• Serum bilirubin = 1.5mg/dl. ALT(Alanine transaminase ), AST(Aspartate Transaminase) = 2.5 x upper normal limit (or = 2.5 x upper normal limit in the case of liver metastases)

• Life expectancy = 3 months

• Patients who have given written informed consent to participate in this study

Exclusion Criteria:

• Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer)

• Serious, uncontrolled, concurrent infection(s) or illness(es)

• Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia)

• Patients with brain metastasis

• Patients receiving continuous administration of steroids

• Patients who have experienced serious drug allergy in the past

• Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment

• Patients who are pregnant and lactating or hope to become pregnant during the study period

• Patients with prior Taxane treatment (Paclitaxel)

• Others, patients judged by the investigator or coinvestigator to be inappropriate as subject

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Paclitaxel liposome

• Cisplatin

• 5-fluorouracil

Locations

Country	Name	City	State
China	Department of medical oncology,Cancer hospital of Shantou University Medical colledge	Shantou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shantou University Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time to progression		6 months	No
Primary	median overall survival		one year	No
Secondary	median progression free survival		6 months	No