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

Primary Purpose

Esophageal Cancer

Status
Withdrawn
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Paclitaxel liposome
Cisplatin
5-fluorouracil
Sponsored by
Shantou University Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paclitaxel liposome and Cisplatin

Cisplatin plus 5-fluorouracil

Arm Description

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: 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.

Outcomes

Primary Outcome Measures

median overall survival

Secondary Outcome Measures

median progression free survival

Full Information

First Posted
November 17, 2013
Last Updated
November 18, 2015
Sponsor
Shantou University Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT01998347
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Why Stopped
slow enrollment
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shantou University Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel liposome and Cisplatin
Arm Type
Experimental
Arm Description
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.
Arm Title
Cisplatin plus 5-fluorouracil
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel liposome
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Primary Outcome Measure Information:
Title
median overall survival
Time Frame
one year
Secondary Outcome Measure Information:
Title
median progression free survival
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
time to progression
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of medical oncology,Cancer hospital of Shantou University Medical colledge
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515031
Country
China

12. IPD Sharing Statement

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

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