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

NCT ID: NCT01998347

Last Updated: 2015-11-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paclitaxel liposome and 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.

Group Type: EXPERIMENTAL

Paclitaxel liposome

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Cisplatin plus 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.

Group Type: ACTIVE_COMPARATOR

Cisplatin

Intervention Type: DRUG

5-fluorouracil

Intervention Type: DRUG

Interventions

Paclitaxel liposome

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

5-fluorouracil

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shantou University Medical College

OTHER

Sponsor Role: lead

Responsible Party

Lin Yingcheng

deputy secretary

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of medical oncology,Cancer hospital of Shantou University Medical colledge

Shantou, Guangdong, China

Countries

China

Other Identifiers

LYC01

Identifier Type: OTHER

Identifier Source: secondary_id

CSMECS 01

Identifier Type: -

Identifier Source: org_study_id