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

July 31, 2014 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.

A Randomized Controlled Multicenter Trial of Endostar and/or Cisplatin in Patients With Malignant Pleural Effusion or Ascites

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

336

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cisplatin
Drug: Cisplatin
cisplatin 40 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles
Active Comparator: Endostar
Drug: Endostar
intrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles
Experimental: Endostar and Cisplatin
Drug: Endostar
intrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles
Drug: Cisplatin
cisplatin 40 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: baseline to measured progressive disease, every three weeks
WHO criteria
baseline to measured progressive disease, every three weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Progression
Time Frame: baseline to every three weeks until disease progression
baseline to every three weeks until disease progression
Quality of Life
Time Frame: baseline to every three weeks
baseline to every three weeks
Incidence of Adverse Events
Time Frame: Up to 1 month after the last treatment
Up to 1 month after the last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Shukui Qin, MD, The 81st Hospital of Chinese PLA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

March 31, 2011

First Posted (Estimate)

April 1, 2011

Study Record Updates

Last Update Posted (Estimate)

August 1, 2014

Last Update Submitted That Met QC Criteria

July 31, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIM-90

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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