Paclitaxel Liposome and Cisplatin as First-line Chemother... | NCT01998347

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

NCT01998347

Sponsor

Shantou University Medical College

Status

Withdrawn

Last Update Posted

Nov 20, 2015Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Esophageal Cancer

Interventions

Paclitaxel liposome
Cisplatin
5-fluorouracil

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
LYC01	Other Identifier	ShantouUMC

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

slow enrollment

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Dec 2017Estimated

Completion Date

Not provided

First Submitted Date

Nov 17, 2013

First Submission Date that Met QC Criteria

Nov 23, 2013

First Posted Date

Nov 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2015

Last Update Posted Date

Nov 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Paclitaxel liposome and Cisplatin	Experimental	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.	Drug: Paclitaxel liposome Drug: Cisplatin
Cisplatin plus 5-fluorouracil	Active Comparator	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.	Drug: Cisplatin Drug: 5-fluorouracil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paclitaxel liposome	Drug		Paclitaxel liposome and Cisplatin
Cisplatin

Measure	Description	Time Frame
median overall survival		one year

Measure	Description	Time Frame
median progression free survival		6 months

Measure	Description	Time Frame
time to progression		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D002945	Cisplatin
D005472	Fluorouracil

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds