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

Phase 3

Withdrawn

• Conditions: Esophageal Cancer
• Interventions: Drug: Paclitaxel liposome; Drug: Cisplatin; Drug: 5-fluorouracil

• Registration Number: NCT01998347
• Lead Sponsor: Shantou University Medical College

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-17
• Study First Submitted QC: 2013-11-23
• Study First Posted: 2013-11-28
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-18
• Last Update Posted: 2015-11-20
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paclitaxel liposome and Cisplatin	Paclitaxel liposome	Drug: paclitaxel liposome 175mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles:up to 6 cycles. Drug: cisplatin 37.5 mg/m2, IV (in the vein) on day 1\~2 of each 21 day cycle. Number of Cycles: up to 6 cycles.
Paclitaxel liposome and Cisplatin	Cisplatin	Drug: paclitaxel liposome 175mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles:up to 6 cycles. Drug: cisplatin 37.5 mg/m2, IV (in the vein) on day 1\~2 of each 21 day cycle. Number of Cycles: up to 6 cycles.
Cisplatin plus 5-fluorouracil	Cisplatin	Cisplatin: 37.5 mg/m2, IV (in the vein) on day 1-2 of each 21 day cycle. Number of Cycles: up to 6 cycles. 5-fluorouracil: 200mg/m2, CIV (continuous intravenous infusion) on day 1\~5 of each 21 day cycle. Number of Cycles: up to 6 cycles.
Cisplatin plus 5-fluorouracil	5-fluorouracil	Cisplatin: 37.5 mg/m2, IV (in the vein) on day 1-2 of each 21 day cycle. Number of Cycles: up to 6 cycles. 5-fluorouracil: 200mg/m2, CIV (continuous intravenous infusion) on day 1\~5 of each 21 day cycle. Number of Cycles: up to 6 cycles.

Primary Outcome Measures

Name	Time	Method
median overall survival	one year

Secondary Outcome Measures

Name	Time	Method
median progression free survival	6 months

Trial Locations

Locations (1)

Department of medical oncology,Cancer hospital of Shantou University Medical colledge; 🇨🇳 Shantou, Guangdong, China