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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01327235
First received: March 28, 2011
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Malignant Pleural Effusion
Malignant Ascites
Drug: Endostar
Drug: Cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Multicenter Trial of Endostar and/or Cisplatin in Patients With Malignant Pleural Effusion or Ascites

Resource links provided by NLM:


Further study details as provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: baseline to measured progressive disease, every three weeks ] [ Designated as safety issue: No ]
    WHO criteria


Secondary Outcome Measures:
  • Time to Progression [ Time Frame: baseline to every three weeks until disease progression ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: baseline to every three weeks ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: Up to 1 month after the last treatment ] [ Designated as safety issue: Yes ]

Enrollment: 336
Study Start Date: March 2011
Study Completion Date: July 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: Cisplatin Drug: Cisplatin
cisplatin 40 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327235

Locations
China
The 81st Hospital of Chinese PLA
Nanjing, China
The Affiliated Hospital of Medical College, QingDao University
Qingdao, China
Fudan University Shanghai Cancer Center
Shanghai, China
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Shukui Qin, MD The 81st Hospital of Chinese PLA
  More Information

No publications provided

Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01327235     History of Changes
Other Study ID Numbers: SIM-90
Study First Received: March 28, 2011
Last Updated: July 31, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Ascites
Pleural Effusion
Pleural Effusion, Malignant
Pathologic Processes
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 20, 2014