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Endostar and/or Cisplatin for Treatment of Malignant Pleural Effusion or Ascites

Primary Purpose

Malignant Pleural Effusion, Malignant Ascites

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Endostar
Cisplatin
Sponsored by
Jiangsu Simcere Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Effusion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histological or cytological diagnosis of thoracic or abdominal tumor
  • At least medium amount of malignant pleural effusion or ascites
  • ECOG Performance Status 0-2
  • Life expectancy ≥ 2 months
  • Adequate hematologic, cardiac, renal, and hepatic function
  • No major surgery within 4 weeks prior to this study
  • Written informed consent

Exclusion Criteria:

  • Patients with central nervous system (CNS) metastases
  • Evidence of bleeding diathesis, serious infection
  • Evidence of myocardial infarction, unstable angina or cardiac insufficiency
  • Presence of serious COPD and/or respiratory failure
  • Allergic to study drug
  • Pregnant or lactating women
  • Participation in other clinical trials within 30 days prior to this study

Sites / Locations

  • The 81st Hospital of Chinese PLA
  • The Affiliated Hospital of Medical College, QingDao University
  • Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Endostar

Cisplatin

Endostar and Cisplatin

Arm Description

Outcomes

Primary Outcome Measures

Objective Response Rate
WHO criteria

Secondary Outcome Measures

Time to Progression
Quality of Life
Incidence of Adverse Events

Full Information

First Posted
March 28, 2011
Last Updated
July 31, 2014
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01327235
Brief Title
Endostar and/or Cisplatin for Treatment of Malignant Pleural Effusion or Ascites
Official Title
A Randomized Controlled Multicenter Trial of Endostar and/or Cisplatin in Patients With Malignant Pleural Effusion or Ascites
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to compare the efficacy of Endostar/cisplatin with cisplatin alone or Endostar alone in patients with malignant pleural effusion or ascites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion, Malignant Ascites

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
336 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endostar
Arm Type
Active Comparator
Arm Title
Cisplatin
Arm Type
Active Comparator
Arm Title
Endostar and Cisplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Endostar
Intervention Description
intrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
cisplatin 40 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
WHO criteria
Time Frame
baseline to measured progressive disease, every three weeks
Secondary Outcome Measure Information:
Title
Time to Progression
Time Frame
baseline to every three weeks until disease progression
Title
Quality of Life
Time Frame
baseline to every three weeks
Title
Incidence of Adverse Events
Time Frame
Up to 1 month after the last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological or cytological diagnosis of thoracic or abdominal tumor At least medium amount of malignant pleural effusion or ascites ECOG Performance Status 0-2 Life expectancy ≥ 2 months Adequate hematologic, cardiac, renal, and hepatic function No major surgery within 4 weeks prior to this study Written informed consent Exclusion Criteria: Patients with central nervous system (CNS) metastases Evidence of bleeding diathesis, serious infection Evidence of myocardial infarction, unstable angina or cardiac insufficiency Presence of serious COPD and/or respiratory failure Allergic to study drug Pregnant or lactating women Participation in other clinical trials within 30 days prior to this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shukui Qin, MD
Organizational Affiliation
The 81st Hospital of Chinese PLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 81st Hospital of Chinese PLA
City
Nanjing
Country
China
Facility Name
The Affiliated Hospital of Medical College, QingDao University
City
Qingdao
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China

12. IPD Sharing Statement

Learn more about this trial

Endostar and/or Cisplatin for Treatment of Malignant Pleural Effusion or Ascites

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