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

This study is currently recruiting participants.
Verified January 2013 by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01327235
First received: March 28, 2011
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  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:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by Jiangsu Simcere Pharmaceutical R&D 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 ]

Estimated Enrollment: 336
Study Start Date: March 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: November 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327235

Contacts
Contact: Zongyuan Li 86-25-85566666 ext 1610

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

No publications provided

Responsible Party: Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
ClinicalTrials.gov Identifier: NCT01327235     History of Changes
Other Study ID Numbers: SIM-90
Study First Received: March 28, 2011
Last Updated: January 14, 2013
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
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013