Clinical trial NCT01998347: Paclitaxel Liposome and Cisplatin as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer
Official title: Paclitaxel Liposome and Cisplatin as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer: an Open-label, Randomised Phase 3 Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Esophageal Cancer
Lead sponsor: Shantou University Medical College
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: median overall survival
timeFrame: one year
Secondary outcomes:
measure: median progression free survival
timeFrame: 6 months
Other outcomes:
measure: time to progression
timeFrame: 6 months
Locations:
city: Shantou
country: China
facility: Department of medical oncology,Cancer hospital of Shantou University Medical colledge
state: Guangdong
Study officials:
References: